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American Diabetes Association

Standards of
Medical Care in
Diabetesd2019
January 2019 Volume 42, Supplement 1

[T]he simple word Care may suffice to express [the journal’s] philosophical
mission. The new journal is designed to promote better patient care by
serving the expanded needs of all health professionals committed to the care
of patients with diabetes. As such, the American Diabetes Association views
Diabetes Care as a reaffirmation of Francis Weld Peabody’s contention that
“the secret of the care of the patient is in caring for the patient.”
—Norbert Freinkel, Diabetes Care, January-February 1978

EDITOR IN CHIEF

Matthew C. Riddle, MD

ASSOCIATE EDITORS EDITORIAL BOARD

George Bakris, MD Andrew J. Ahmann, MD Philip Home, DM, DPhil


Lawrence Blonde, MD, FACP Vanita R. Aroda, MD George S. Jeha, MD
Andrew J.M. Boulton, MD Linda A. Barbour, MD, MSPH Lee M. Kaplan, MD, PhD
David D’Alessio, MD Roy W. Beck, MD, PhD M. Sue Kirkman, MD
Eddie L. Greene, MD Gianni Bellomo, MD Ildiko Lingvay, MD, MPH, MSCS
Korey K. Hood, PhD Geremia Bolli, MD Maureen Monaghan, PhD, CDE
Frank B. Hu, MD, MPH, PhD John B. Buse, MD, PhD Kristen J. Nadeau, MD, MS
Steven E. Kahn, MB, ChB Sonia Caprio, MD Gregory A. Nichols, PhD, MBA
Sanjay Kaul, MD, FACC, FAHA Jessica R. Castle, MD Kwame Osei, MD
Derek LeRoith, MD, PhD Robert J. Chilton, DO, FACC, FAHA Kevin A. Peterson, MD, MPH, FRCS(Ed),
Robert G. Moses, MD Kenneth Cusi, MD, FACP, FACE FAAFP
Stephen Rich, PhD J. Hans DeVries, MD, PhD Ravi Retnakaran, MD, MSc, FRCPC
Julio Rosenstock, MD Ele Ferrannini, MD Elizabeth Seaquist, MD
Judith Wylie-Rosett, EdD, RD Thomas W. Gardner, MD, MS Guntram Schernthaner, MD
Jennifer Green, MD Jan S. Ulbrecht, MB, BS
Meredith A. Hawkins, MD, MS Ram Weiss, MD, PhD
Petr Heneberg, RNDr, PhD Deborah Wexler, MD, MSc
Norbert Hermanns, PhD, MSc Vincent C. Woo, MD, FRCPC
Irl B. Hirsch, MD, MACP Bernard Zinman, CM, MD, FRCPC, FACP
Reinhard W. Holl, MD, PhD

AMERICAN DIABETES ASSOCIATION OFFICERS


CHAIR OF THE BOARD PRESIDENT-ELECT, MEDICINE & SCIENCE
Karen Talmadge, PhD Louis Philipson, MD
PRESIDENT, MEDICINE & SCIENCE PRESIDENT-ELECT, HEALTH CARE &
Jane Reusch, MD EDUCATION
Gretchen Youssef, MS, RD, CDE
PRESIDENT, HEALTH CARE &
EDUCATION SECRETARY/TREASURER-ELECT
Felicia Hill-Briggs, PhD, ABPP Brian Bertha, JD, MBA
SECRETARY/TREASURER CHIEF EXECUTIVE OFFICER
Michael Ching, CPA Tracey D. Brown, MBA, BChE
CHAIR OF THE BOARD-ELECT CHIEF SCIENTIFIC, MEDICAL & MISSION OFFICER
David J. Herrick, MBA William T. Cefalu, MD

The mission of the American Diabetes Association


is to prevent and cure diabetes and to improve
the lives of all people affected by diabetes.
Diabetes Care is a journal for the health care practitioner that is intended to
increase knowledge, stimulate research, and promote better management of people
with diabetes. To achieve these goals, the journal publishes original research on
human studies in the following categories: Clinical Care/Education/Nutrition/
Psychosocial Research, Epidemiology/Health Services Research, Emerging
Technologies and Therapeutics, Pathophysiology/Complications, and Cardiovascular
and Metabolic Risk. The journal also publishes ADA statements, consensus reports,
clinically relevant review articles, letters to the editor, and health/medical news or points
of view. Topics covered are of interest to clinically oriented physicians, researchers,
epidemiologists, psychologists, diabetes educators, and other health professionals.
More information about the journal can be found online at care.diabetesjournals.org.
Copyright © 2018 by the American Diabetes Association, Inc. All rights reserved. Printed in
the USA. Requests for permission to reuse content should be sent to Copyright Clearance
Center at www.copyright.com or 222 Rosewood Dr., Danvers, MA 01923; phone: (978)
750-8400; fax: (978) 646-8600. Requests for permission to translate should be sent to
Permissions Editor, American Diabetes Association, at permissions@diabetes.org.
The American Diabetes Association reserves the right to reject any advertisement for
any reason, which need not be disclosed to the party submitting the advertisement.
Commercial reprint orders should be directed to Sheridan Content Services,
(800) 635-7181, ext. 8065.
Single issues of Diabetes Care can be ordered by calling toll-free (800) 232-3472, 8:30 A.M.
to 5:00 P.M. EST, Monday through Friday. Outside the United States, call (703) 549-1500.
Rates: $75 in the United States, $95 in Canada and Mexico, and $125 for all other countries.
Diabetes Care is available online at care.diabetesjournals.org. Please call the
numbers listed above, e-mail membership@diabetes.org, or visit the online journal for
more information about submitting manuscripts, publication charges, ordering reprints,
PRINT ISSN 0149-5992 subscribing to the journal, becoming an ADA member, advertising, permission to reuse
ONLINE ISSN 1935-5548 content, and the journal’s publication policies.
PRINTED IN THE USA Periodicals postage paid at Arlington, VA, and additional mailing offices.

AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS


ASSOCIATE PUBLISHER, EDITORIAL CONTENT MANAGER ADVERTISING REPRESENTATIVES
SCHOLARLY JOURNALS Nancy C. Baldino
Christian S. Kohler American Diabetes Association
Paul Nalbandian
Associate Publisher, Advertising &
TECHNICAL EDITORS
EDITORIAL OFFICE DIRECTOR Sponsorships
Theresa Cooper pnalbandian@diabetes.org
Lyn Reynolds
Donna J. Reynolds (703) 549-1500, ext. 4806
Tina Auletta
PEER REVIEW MANAGER
DIRECTOR, MEMBERSHIP/SUBSCRIPTION Senior Account Executive
Shannon Potts
SERVICES tauletta@diabetes.org
Donald Crowl (703) 549-1500, ext. 4809
ASSOCIATE MANAGER, PEER REVIEW PHARMACEUTICAL/DEVICE DIGITAL ADVERTISING
Larissa M. Pouch The Walchli Tauber Group
SENIOR ADVERTISING MANAGER Maura Paoletti
Julie DeVoss Graff National Sales Manager
DIRECTOR, SCHOLARLY JOURNALS jgraff@diabetes.org maura.paoletti@wt-group.com
Heather Norton Blackburn (703) 299-5511 (443) 512-8899, ext. 110
January 2019 Volume 42, Supplement 1

Standards of Medical Care in Diabetes—2019


S1 Introduction S90 9. Pharmacologic Approaches to Glycemic
S3 Professional Practice Committee Treatment
Pharmacologic Therapy for Type 1 Diabetes
S4 Summary of Revisions: Standards of Medical Care in Surgical Treatment for Type 1 Diabetes
Diabetes—2019 Pharmacologic Therapy for Type 2 Diabetes
S7 1. Improving Care and Promoting Health in S103 10. Cardiovascular Disease and Risk
Populations Management
Diabetes and Population Health Hypertension/Blood Pressure Control
Tailoring Treatment for Social Context Lipid Management
Antiplatelet Agents
S13 2. Classification and Diagnosis of Diabetes Cardiovascular Disease
Classification
Diagnostic Tests for Diabetes S124 11. Microvascular Complications and Foot Care
A1C Chronic Kidney Disease
Type 1 Diabetes Diabetic Retinopathy
Prediabetes and Type 2 Diabetes Neuropathy
Gestational Diabetes Mellitus Foot Care
Cystic Fibrosis–Related Diabetes
Posttransplantation Diabetes Mellitus S139 12. Older Adults
Monogenic Diabetes Syndromes Neurocognitive Function
Hypoglycemia
S29 3. Prevention or Delay of Type 2 Diabetes Treatment Goals
Lifestyle Interventions Lifestyle Management
Pharmacologic Interventions Pharmacologic Therapy
Prevention of Cardiovascular Disease Treatment in Skilled Nursing Facilities
Diabetes Self-management Education and Support and Nursing Homes
End-of-Life Care
S34 4. Comprehensive Medical Evaluation and S148 13. Children and Adolescents
Assessment of Comorbidities
Type 1 Diabetes
Patient-Centered Collaborative Care Type 2 Diabetes
Comprehensive Medical Evaluation Transition From Pediatric to Adult Care
Assessment of Comorbidities
S165 14. Management of Diabetes in Pregnancy
S46 5. Lifestyle Management
Diabetes in Pregnancy
Diabetes Self-management Education and Support Preconception Counseling
Nutrition Therapy Glycemic Targets in Pregnancy
Physical Activity Management of Gestational Diabetes Mellitus
Smoking Cessation: Tobacco and e-Cigarettes Management of Preexisting Type 1 Diabetes
Psychosocial Issues and Type 2 Diabetes in Pregnancy
S61 6. Glycemic Targets Pregnancy and Drug Considerations
Postpartum Care
Assessment of Glycemic Control
A1C Goals S173 15. Diabetes Care in the Hospital
Hypoglycemia Hospital Care Delivery Standards
Intercurrent Illness Glycemic Targets in Hospitalized Patients
Bedside Blood Glucose Monitoring
S71 7. Diabetes Technology Antihyperglycemic Agents in Hospitalized Patients
Insulin Delivery Hypoglycemia
Self-monitoring of Blood Glucose Medical Nutrition Therapy in the Hospital
Continuous Glucose Monitors Self-management in the Hospital
Automated Insulin Delivery Standards for Special Situations
Transition From the Acute Care Setting
S81 8. Obesity Management for the Treatment of Type 2 Preventing Admissions and Readmissions
Diabetes
Assessment S182 16. Diabetes Advocacy
Diet, Physical Activity, and Behavioral Therapy Advocacy Statements
Pharmacotherapy
Medical Devices for Weight Loss S184 Disclosures
Metabolic Surgery S187 Index

This issue is freely accessible online at care.diabetesjournals.org/content/42/Supplement_1.

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Diabetes Care Volume 42, Supplement 1, January 2019 S1

Introduction: Standards of Medical


Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S1–S2 | https://doi.org/10.2337/dc19-SINT01

Diabetes is a complex, chronic illness The ADA strives to improve and update updates the Standards of Care annually.
requiring continuous medical care with the Standards of Care to ensure that However, the Standards of Care is a
multifactorial risk-reduction strategies clinicians, health plans, and policy makers “living” document, where notable up-
beyond glycemic control. Ongoing pa- can continue to rely on them as the most dates are incorporated online should
tient self-management education and authoritative and current guidelines for the PPC determine that new evidence or
support are critical to preventing acute diabetes care. To improve access, the regulatory changes (e.g., drug approvals,
complications and reducing the risk of Standards of Care is now available label changes) merit immediate inclusion.
long-term complications. Significant ev- through ADA’s new interactive app, along More information on the “living Standards”

INTRODUCTION
idence exists that supports a range of with tools and calculators that can help can be found on DiabetesPro at profes-
interventions to improve diabetes out- guide patient care. To download the app, sional.diabetes.org/content-page/living-
comes. please visit professional.diabetes.org/ standards. The Standards of Care
The American Diabetes Association’s SOCapp. Readers who wish to com- supersedes all previous ADA position
(ADA’s) “Standards of Medical Care in ment on the 2019 Standards of Care statementsdand the recommendations
Diabetes,” referred to as the Standards of are invited to do so at professional. thereindon clinical topics within the
Care, is intended to provide clinicians, diabetes.org/SOC. purview of the Standards of Care; ADA
patients, researchers, payers, and other position statements, while still con-
interested individuals with the compo- ADA STANDARDS, STATEMENTS, taining valuable analysis, should not be
nents of diabetes care, general treat- REPORTS, and REVIEWS considered the ADA’s current position.
ment goals, and tools to evaluate the The ADA has been actively involved in the The Standards of Care receives annual
quality of care. The Standards of Care development and dissemination of di- review and approval by the ADA Board
recommendations are not intended to abetes care standards, guidelines, and of Directors.
preclude clinical judgment and must be related documents for over 25 years. The ADA Statement
applied in the context of excellent ADA’s clinical practice recommendations An ADA statement is an official ADA
clinical care, with adjustments for in- are viewed as important resources for point of view or belief that does not
dividual preferences, comorbidities, health care professionals who care for contain clinical practice recommenda-
and other patient factors. For more people with diabetes. tions and may be issued on advocacy,
detailed information about manage-
policy, economic, or medical issues re-
ment of diabetes, please refer to Med- Standards of Care
lated to diabetes.
ical Management of Type 1 Diabetes This document is an official ADA posi-
ADA statements undergo a formal
(1) and Medical Management of Type 2 tion, is authored by the ADA, and pro-
review process, including a review by
Diabetes (2). vides all of the ADA’s current clinical
the appropriate national committee,
The recommendations include screen- practice recommendations.
ADA mission staff, and the ADA Board
ing, diagnostic, and therapeutic act- To update the Standards of Care, the
of Directors.
ions that are known or believed to ADA’s Professional Practice Committee
favorably affect health outcomes of (PPC) performs an extensive clinical di- Consensus Report
patients with diabetes. Many of these abetes literature search, supple- A consensus report of a particular topic
interventions have also been shown to mented with input from ADA staff and contains a comprehensive examination
be cost-effective (3). the medical community at large. The PPC and is authored by an expert panel (i.e.,

“Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: December 2018.
© 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
S2 Introduction Diabetes Care Volume 42, Supplement 1, January 2019

Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes” that forms the basis for the recommen-
Level of evidence Description
dations. ADA recommendations are as-
signed ratings of A, B, or C, depending on
A Clear evidence from well-conducted, generalizable randomized controlled
the quality of evidence. Expert opinion
trials that are adequately powered, including
E is a separate category for recommen-
c Evidence from a well-conducted multicenter trial
c Evidence from a meta-analysis that incorporated quality ratings in the
dations in which there is no evidence
analysis from clinical trials, in which clinical trials
Compelling nonexperimental evidence, i.e., “all or none” rule developed by may be impractical, or in which there
the Centre for Evidence-Based Medicine at the University of Oxford is conflicting evidence. Recommenda-
Supportive evidence from well-conducted randomized controlled trials that tions with an A rating are based on large
are adequately powered, including well-designed clinical trials or well-done
c Evidence from a well-conducted trial at one or more institutions meta-analyses. Generally, these recom-
c Evidence from a meta-analysis that incorporated quality ratings in the mendations have the best chance of
analysis improving outcomes when applied to
B Supportive evidence from well-conducted cohort studies the population to which they are ap-
c Evidence from a well-conducted prospective cohort study or registry
propriate. Recommendations with lower
c Evidence from a well-conducted meta-analysis of cohort studies
levels of evidence may be equally im-
Supportive evidence from a well-conducted case-control study
portant but are not as well supported.
C Supportive evidence from poorly controlled or uncontrolled studies Of course, evidence is only one com-
c Evidence from randomized clinical trials with one or more major or three
ponent of clinical decision making. Clini-
or more minor methodological flaws that could invalidate the results
cians care for patients, not populations;
c Evidence from observational studies with high potential for bias (such as
case series with comparison with historical controls) guidelines must always be interpreted
c Evidence from case series or case reports
with the individual patient in mind. In-
Conflicting evidence with the weight of evidence supporting the dividual circumstances, such as comorbid
recommendation and coexisting diseases, age, education,
E Expert consensus or clinical experience disability, and, above all, patients’ values
and preferences, must be considered
and may lead to different treatment tar-
gets and strategies. Furthermore, con-
consensus panel) and represents the by invited experts. The scientific review ventional evidence hierarchies, such as
panel’s collective analysis, evaluation, may provide a scientific rationale for the one adapted by the ADA, may miss
and opinion. clinical practice recommendations in the nuances important in diabetes care. For
The need for a consensus report arises Standards of Care. The category may also example, although there is excellent
when clinicians, scientists, regulators, include task force and expert committee evidence from clinical trials supporting
and/or policy makers desire guidance reports. the importance of achieving multiple
and/or clarity on a medical or scientific risk factor control, the optimal way to
issue related to diabetes for which the GRADING OF SCIENTIFIC EVIDENCE achieve this result is less clear. It is dif-
evidence is contradictory, emerging, or ficult to assess each component of such
Since the ADA first began publishing
incomplete. Consensus reports may also a complex intervention.
practice guidelines, there has been con-
highlight gaps in evidence and propose
siderable evolution in the evaluation of
areas of future research to address these
scientific evidence and in the develop- References
gaps. A consensus report is not an ADA
ment of evidence-based guidelines. In 1. American Diabetes Association. Medical
position and represents expert opinion Management of Type 1 Diabetes. 7th ed.
2002, the ADA developed a classification
only but is produced under the auspices Wang CC, Shah AC, Eds. Alexandria, VA, American
system to grade the quality of scientific
of the Association by invited experts. Diabetes Association, 2017
evidence supporting ADA recommen- 2. American Diabetes Association. Medical
A consensus report may be developed
dations. A 2015 analysis of the evi- Management of Type 2 Diabetes. 7th ed.
after an ADA Clinical Conference or Re-
dence cited in the Standards of Care Burant CF, Young LA, Eds. Alexandria, VA,
search Symposium. American Diabetes Association, 2012
found steady improvement in quality
3. Li R, Zhang P, Barker LE, Chowdhury FM,
Scientific Review over the previous 10 years, with the Zhang X. Cost-effectiveness of interventions to
A scientific review is a balanced review 2014 Standards of Care for the first prevent and control diabetes mellitus: a sys-
and analysis of the literature on a scien- time having the majority of bulleted tematic review. Diabetes Care 2010;33:1872–
tific or medical topic related to diabetes. recommendations supported by A- or 1894
A scientific review is not an ADA po- B-level evidence (4). A grading system 4. Grant RW, Kirkman MS. Trends in the ev-
idence level for the American Diabetes As-
sition and does not contain clinical prac- (Table 1) developed by the ADA and sociation’s “Standards of Medical Care in
tice recommendations but is produced modeled after existing methods was Diabetes” from 2005 to 2014. Diabetes Care
under the auspices of the Association used to clarify and codify the evidence 2015;38:6–8
Diabetes Care Volume 42, Supplement 1, January 2019 S3

Professional Practice Committee:


Standards of Medical Care in
Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S3| https://doi.org/10.2337/dc19-SPPC01

The Professional Practice Committee For the current revision, PPC mem- Members of the PPC
(PPC) of the American Diabetes Associ- bers systematically searched MEDLINE Joshua J. Neumiller, PharmD, CDE, FASCP*
ation (ADA) is responsible for the “Stan- for human studies related to each section (Chair)
dards of Medical Care in Diabetes,” and published since 15 October 2017. Christopher P. Cannon, MD

PROFESSIONAL PRACTICE COMMITTEE


referred to as the Standards of Care. Recommendations were revised based Jill Crandall, MD
The PPC is a multidisciplinary expert on new evidence or, in some cases, to David D’Alessio, MD
committee comprised of physicians, clarify the prior recommendation or Ian H. de Boer, MD, MS*
diabetes educators, and others who match the strength of the wording to Mary de Groot, PhD
have expertise in a range of areas, the strength of the evidence. A table Judith Fradkin, MD
including adult and pediatric endocri- linking the changes in recommendations Kathryn Evans Kreider, DNP, APRN,
nology, epidemiology, public health, to new evidence can be reviewed at FNP-BC, BC-ADM
lipid research, hypertension, precon- professional.diabetes.org/SOC. The Stan- David Maahs, MD, PhD
ception planning, and pregnancy care. dards of Care was approved by ADA’s Nisa Maruthur, MD, MHS
Appointment to the PPC is based on Board of Directors, which includes health Medha N. Munshi, MD*
excellence in clinical practice and re- care professionals, scientists, and lay people. Maria Jose Redondo, MD, PhD, MPH
search. Although the primary role of Feedback from the larger clinical com- Guillermo E. Umpierrez, MD, CDE, FACE,
the PPC is to review and update the munity was valuable for the 2018 revision FACP*
Standards of Care, it may also be in- of the Standards of Care. Readers who Jennifer Wyckoff, MD
volved in ADA statements, reports, and wish to comment on the 2019 Standards *Subgroup leaders
reviews. of Care are invited to do so at professional
The ADA adheres to the National .diabetes.org/SOC. ADA Nutrition Consensus Report
Academy of Medicine Standards for De- The PPC would like to thank the fol- Writing GroupdLiaison
veloping Trustworthy Clinical Practice lowing individuals who provided their Melinda Maryniuk, MEd, RDN, CDE
Guidelines. All members of the PPC expertise in reviewing and/or consulting
are required to disclose potential con- with the committee: Ann Albright, PhD, RD; American College of
flicts of interest with industry and/or Pamela Allweiss, MD, MPH; Barbara J. CardiologydDesignated
other relevant organizations. These dis- Anderson, PhD; George Bakris, MD; Richard Representatives (Section 10)
closures are discussed at the onset of Bergenstal, MD; Stuart Brink, MD; Donald Sandeep Das, MD, MPH, FACC
each Standards of Care revision meeting. R. Coustan, MD; Ellen D. Davis, MS, RN, Mikhail Kosiborod, MD, FACC
Members of the committee, their em- CDE, FAADE; Jesse Dinh, PharmD; Steven
ployers, and their disclosed conflicts of Edelman, MD; Barry H. Ginsberg, MD, PhD; ADA Staff
interest are listed in the “Disclosures: Irl B. Hirsch, MD; Scott Kahan, MD, MPH; Erika Gebel Berg, PhD
Standards of Medical Care in Diabetesd David Klonoff, MD; Joyce Lee, MD, MPH; (correspondingauthor:eberg@diabetes.org)
2019” table (see pp. S184–S186). The Randie Little, PhD; Alexandra Migdal, MD; Mindy Saraco, MHA
ADA funds development of the Stand- Anne Peters, MD; Amy Rothberg, MD; Matthew P. Petersen
ards of Care out of its general revenues Jennifer Sherr, MD, PhD; Hood Thabit, Sacha Uelmen, RDN, CDE
and does not use industry support for MB, BCh, MD, PhD; Stuart Alan Weinzimer, Shamera Robinson, MPH, RDN
this purpose. MD; and Neil White, MD. William T. Cefalu, MD

© 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
S4 Diabetes Care Volume 42, Supplement 1, January 2019

Summary of Revisions: Standards


of Medical Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S4–S6 | https://doi.org/10.2337/dc19-srev01

GENERAL CHANGES Because telemedicine is a growing professional audiences in an informative,


The field of diabetes care is rapidly field that may increase access to care empowering, and educational style.
changing as new research, technology, for patients with diabetes, discussion was A new figure from the ADA-European
and treatments that can improve the added on its use to facilitate remote Association for the Study of Diabetes
health and well-being of people with delivery of health-related services and (EASD) consensus report about the di-
diabetes continue to emerge. With an- clinical information. abetes care decision cycle was added to
nual updates since 1989, the American emphasize the need for ongoing assess-
Section 2. Classification and Diagnosis ment and shared decision making to
Diabetes Association (ADA) has long
of Diabetes achieve the goals of health care and
been a leader in producing guidelines
SUMMARY OF REVISIONS

Based on new data, the criteria for the avoid clinical inertia.
that capture the most current state of
diagnosis of diabetes was changed to
the field. To that end, the “Standards A new recommendation was added to
include two abnormal test results from explicitly call out the importance of the
of Medical Care in Diabetes” (Standards
the same sample (i.e., fasting plasma diabetes care team and to list the pro-
of Care) now includes a dedicated section
glucose and A1C from same sample). fessionals that make up the team.
on Diabetes Technology, which contains
The section was reorganized to im- The table listing the components of a
preexisting material that was previously
prove flow and reduce redundancy. comprehensive medical evaluation was
in other sections that has been consol-
Additional conditions were identified revised, and the section on assessment
idated, as well as new recommendations.
that may affect A1C test accuracy including and planning was used to create a new
Another general change is that each rec-
the postpartum period. table (Table 4.2).
ommendation is now associated with a
number (i.e., the second recommendation Section 3. Prevention or Delay of
A new table was added listing factors
in Section 7 is now recommendation 7.2). Type 2 Diabetes
that increase risk of treatment-associated
Finally, the order of the prevention section This section was moved (previously it was hypoglycemia (Table 4.3).
was changed (from Section 5 to Section 3) Section 5) and is now located before the A recommendation was added to in-
to follow a more logical progression. Lifestyle Management section to better clude the 10-year atherosclerotic cardio-
Although levels of evidence for several reflect the progression of type 2 diabetes. vascular disease (ASCVD) risk as part of
recommendations have been updated, The nutrition section was updated to overall risk assessment.
these changes are not addressed below highlight the importance of weight loss The fatty liver disease section was
as the clinical recommendations have for those at high risk for developing revised to include updated text and a
remained the same. Changes in evidence type 2 diabetes who have overweight new recommendation regarding when
level from, for example, E to C are not or obesity. to test for liver disease.
noted below. The 2019 Standards of Care Because smoking may increase the risk
contains, in addition to many minor of type 2 diabetes, a section on tobacco Section 5. Lifestyle Management
changes that clarify recommendations use and cessation was added. Evidence continues to suggest that there
or reflect new evidence, the following is not an ideal percentage of calories from
more substantive revisions. Section 4. Comprehensive Medical carbohydrate, protein, and fat for all
Evaluation and Assessment of people with diabetes. Therefore, more
SECTION CHANGES Comorbidities discussion was added about the im-
Section 1. Improving Care and On the basis of a new consensus report portance of macronutrient distribution
Promoting Health in Populations on diabetes and language, new text was based on an individualized assessment of
Additional information was included on added to guide health care professionals’ current eating patterns, preferences, and
the financial costs of diabetes to individ- use of language to communicate about metabolic goals. Additional considera-
uals and society. diabetes with people with diabetes and tions were added to the eating

© 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
care.diabetesjournals.org Summary of Revisions S5

patterns, macronutrient distribution, and intermittently scanned [“flash”]), and au- abbreviated, as these are not generally
meal planning sections to better iden- tomated insulin delivery devices. recommended.
tify candidates for meal plans, specifically The recommendation to use self-
for low-carbohydrate eating patterns monitoring of blood glucose in people
Section 10. Cardiovascular Disease
and people who are pregnant or lactat- who are not using insulin was changed
and Risk Management
ing, who have or are at risk for disor- to acknowledge that routine glucose
For the first time, this section is endorsed
dered eating, who have renal disease, monitoring is of limited additional clin-
by the American College of Cardiology.
and who are taking sodium–glucose co- ical benefit in this population.
Additional text was added to acknowl-
transporter 2 inhibitors. There is not
edge heart failure as an important type
a one-size-fits-all eating pattern for in-
Section 8. Obesity Management for of cardiovascular disease in people with
dividuals with diabetes, and meal plan-
the Treatment of Type 2 Diabetes diabetes for consideration when deter-
ning should be individualized.
A recommendation was modified to mining optimal diabetes care.
A recommendation was modified to
acknowledge the benefits of tracking The blood pressure recommenda-
encourage people with diabetes to de-
weight, activity, etc., in the context of tions were modified to emphasize the
crease consumption of both sugar
achieving and maintaining a healthy importance of individualization of targets
sweetened and nonnutritive-sweetened
weight. based on cardiovascular risk.
beverages and use other alternatives,
A brief section was added on medical A discussion of the appropriate use of
with an emphasis on water intake.
devices for weight loss, which are not the ASCVD risk calculator was included,
The sodium consumption recommen-
currently recommended due to limited and recommendations were modified
dation was modified to eliminate the
data in people with diabetes. to include assessment of 10-year ASCVD
further restriction that was potentially
The recommendations for metabolic risk as part of overall risk assessment
indicated for those with both diabetes
surgery were modified to align with re- and in determining optimal treatment
and hypertension.
cent guidelines, citing the importance of approaches.
Additional discussion was added to the
considering comorbidities beyond dia- The recommendation and text regard-
physical activity section to include the ben-
betes when contemplating the ap- ing the use of aspirin in primary pre-
efit of a variety of leisure-time physical ac-
propriateness of metabolic surgery for vention was updated with new data.
tivities and flexibility and balance exercises.
a given patient. For alignment with the ADA-EASD
The discussion about e-cigarettes was
consensus report, two recommendations
expanded to include more on public
were added for the use of medications
perception and how their use to aide Section 9. Pharmacologic Approaches
that have proven cardiovascular benefit in
smoking cessation was not more effec- to Glycemic Treatment
people with ASCVD, with and without
tive than “usual care.” The section on the pharmacologic treat-
heart failure.
ment of type 2 diabetes was signifi-
cantly changed to align, as per the
Section 6. Glycemic Targets living Standards update in October Section 11. Microvascular
This section now begins with a discussion 2018, with the ADA-EASD consensus Complications and Foot Care
of A1C tests to highlight the centrality of report on this topic, summarized in To align with the ADA-EASD consensus
A1C testing in glycemic management. the new Figs. 9.1 and 9.2. This includes report, a recommendation was added for
The self-monitoring of blood glucose consideration of key patient factors: people with type 2 diabetes and chronic
and continuous glucose monitoring text a) important comorbidities such as kidney disease to consider agents with
and recommendations were moved to ASCVD, chronic kidney disease, and proven benefit with regard to renal out-
the new Diabetes Technology section. heart failure, b) hypoglycemia risk, c) comes.
To emphasize that the risks and ben- effects on body weight, d) side effects, The recommendation on the use of
efits of glycemic targets can change as e) costs, and f) patient preferences. telemedicine in retinal screening was
diabetes progresses and patients age, To align with the ADA-EASD con- modified to acknowledge the utility of
a recommendation was added to reeval- sensus report, the approach to inject- this approach, so long as appropriate
uate glycemic targets over time. able medication therapy was revised referrals are made for a comprehensive
The section was modified to align (Fig. 9.2). A recommendation that, for eye examination.
with the living Standards updates made most patients who need the greater Gabapentin was added to the list of
in April 2018 regarding the consensus efficacy of an injectable medication, a agents to be considered for the treat-
definition of hypoglycemia. glucagon-like peptide 1 receptor ago- ment of neuropathic pain in people with
nist should be the first choice, ahead diabetes based on data on efficacy and
Section 7. Diabetes Technology of insulin. the potential for cost savings.
This new section includes new recommen- A new section was added on insulin The gastroparesis section includes a
dations, the self-monitoring of blood glu- injection technique, emphasizing the im- discussion of a few additional treatment
cose section formerly included in Section portance of technique for appropriate modalities.
6 “Glycemic Targets,” and a discussion of insulin dosing and the avoidance of com- The recommendation for patients with
insulin delivery devices (syringes, pens, and plications (lipodystrophy, etc.). diabetes to have their feet inspected at
insulin pumps), blood glucose meters, con- The section on noninsulin pharmaco- every visit was modified to only include
tinuous glucose monitors (real-time and logic treatments for type 1 diabetes was those at high risk for ulceration. Annual
S6 Summary of Revisions Diabetes Care Volume 42, Supplement 1, January 2019

examinations remain recommended for screening in youth with type 1 diabetes Greater emphasis has been placed on
everyone. beginning at 10–12 years of age. the use of insulin as the preferred med-
Based on new evidence, a recom- ication for treating hyperglycemia in
Section 12. Older Adults mendation was added discouraging gestational diabetes mellitus as it does
A new section and recommendation on e-cigarette use in youth. not cross the placenta to a measurable
lifestyle management was added to address The discussion of type 2 diabetes in extent and how metformin and gly-
the unique nutritional and physical activity children and adolescents was significantly buride should not be used as first-
needs and considerations for older adults. expanded, with new recommendations line agents as both cross the placenta
Within the pharmacologic therapy in a number of areas, including screen- to the fetus.
discussion, deintensification of insulin re- ing and diagnosis, lifestyle management,
gimes was introduced to help simplify pharmacologic management, and transi- Section 15. Diabetes Care in the
insulin regimen to match individual’s tion of care to adult providers. New Hospital
self-management abilities. A new figure sections and/or recommendations for Because of their ability to improve hos-
was added (Fig. 12.1) that provides a path type 2 diabetes in children and adoles- pital readmission rates and cost of care,
for simplification. A new table was also cents were added for glycemic targets, a new recommendation was added call-
added (Table 12.2) to help guide providers metabolic surgery, nephropathy, neurop- ing for providers to consider consulting
considering medication regimen simplifi- athy, retinopathy, nonalcoholic fatty liver with a specialized diabetes or glucose
cation and deintensification/deprescrib- disease, obstructive sleep apnea, poly- management team where possible
ing in older adults with diabetes. cystic ovary syndrome, cardiovascular when caring for hospitalized patients
disease, dyslipidemia, cardiac function with diabetes.
Section 13. Children and Adolescents
testing, and psychosocial factors. Figure
Introductory language was added to the Section 16. Diabetes Advocacy
13.1 was added to provide guidance
beginning of this section reminding the The “Insulin Access and Affordability
on the management of diabetes in
reader that the epidemiology, patho- Working Group: Conclusions and
overweight youth.
physiology, developmental consider- Recommendations” ADA statement was
ations, and response to therapy in added to this section. Published in 2018,
pediatric-onset diabetes are different Section 14. Management of Diabetes this statement compiled public informa-
from adult diabetes, and that there in Pregnancy tion and convened a series of meetings
are also differences in recommended Women with preexisting diabetes are with stakeholders throughout the in-
care for children and adolescents with now recommended to have their care sulin supply chain to learn how each
type 1 as opposed to type 2 diabetes. managed in a multidisciplinary clinic to entity affects the cost of insulin for the
A recommendation was added to em- improve diabetes and pregnancy out- consumer, an important topic for the
phasize the need for disordered eating comes. ADA and people living with diabetes.
Diabetes Care Volume 42, Supplement 1, January 2019 S7

1. Improving Care and Promoting American Diabetes Association

Health in Populations: Standards


of Medical Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S7–S12 | https://doi.org/10.2337/dc19-S001

1. IMPROVING CARE AND PROMOTING HEALTH


The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”
includes ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee, are responsible for updating the Standards of
Care annually, or more frequently as warranted. For a detailed description of ADA
standards, statements, and reports, as well as the evidence-grading system for
ADA’s clinical practice recommendations, please refer to the Standards of Care
Introduction. Readers who wish to comment on the Standards of Care are invited
to do so at professional.diabetes.org/SOC.

DIABETES AND POPULATION HEALTH


Recommendations
1.1 Ensure treatment decisions are timely, rely on evidence-based guidelines, and
are made collaboratively with patients based on individual preferences, prog-
noses, and comorbidities. B
1.2 Align approaches to diabetes management with the Chronic Care Model,
emphasizing productive interactions between a prepared proactive care team
and an informed activated patient. A
1.3 Care systems should facilitate team-based care, patient registries, decision
support tools, and community involvement to meet patient needs. B
1.4 Efforts to assess the quality of diabetes care and create quality improvement
strategies should incorporate reliable data metrics, to promote improved pro-
cesses of care and health outcomes, with simultaneous emphasis on costs. E

Population health is defined as “the health outcomes of a group of individuals,


including the distribution of health outcomes within the group”; these outcomes can
be measured in terms of health outcomes (mortality, morbidity, health, and functional
status), disease burden (incidence and prevalence), and behavioral and metabolic
Suggested citation: American Diabetes Associa-
factors (exercise, diet, A1C, etc.) (1). Clinical practice recommendations for health care tion. 1. Improving care and promoting health
providers are tools that can ultimately improve health across populations; however, in populations: Standards of Medical Care in
for optimal outcomes, diabetes care must also be individualized for each patient. Thus, Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):
efforts to improve population health will require a combination of system-level and S7–S12
patient-level approaches. With such an integrated approach in mind, the American © 2018 by the American Diabetes Association.
Diabetes Association (ADA) highlights the importance of patient-centered care, Readers may use this article as long as the work
is properly cited, the use is educational and not
defined as care that is respectful of and responsive to individual patient preferences, for profit, and the work is not altered. More infor-
needs, and values and that ensures that patient values guide all clinical decisions (2). mation is available at http://www.diabetesjournals
Clinical practice recommendations, whether based on evidence or expert opinion, are .org/content/license.
S8 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019

intended to guide an overall approach to health strategies are needed in order to suboptimal (3). Efforts to increase the
care. The science and art of medicine reduce costs and provide optimized care. quality of diabetes care include provid-
come together when the clinician is faced ing care that is concordant with
with making treatment recommenda- Chronic Care Model evidence-based guidelines (16); expand-
tions for a patient who may not meet Numerous interventions to improve ad- ing the role of teams to implement more
the eligibility criteria used in the studies herence to the recommended standards intensive disease management strate-
on which guidelines are based. Recog- have been implemented. However, a gies (7,17,18); tracking medication-
nizing that one size does not fit all, the major barrier to optimal care is a delivery taking behavior at a systems level (19);
standards presented here provide guid- system that is often fragmented, lacks redesigning the organization of the care
ance for when and how to adapt rec- clinical information capabilities, dupli- process (20); implementing electronic
ommendations for an individual. cates services, and is poorly designed health record tools (21,22); empowering
for the coordinated delivery of chronic and educating patients (23,24); removing
Care Delivery Systems care. The Chronic Care Model (CCM) financial barriers and reducing patient
The proportion of patients with diabetes takes these factors into consideration out-of-pocket costs for diabetes educa-
who achieve recommended A1C, blood and is an effective framework for im- tion, eye exams, diabetes technology, and
pressure, and LDL cholesterol levels has proving the quality of diabetes care (9). necessary medications (7); assessing and
increased in recent years (3). The mean Six Core Elements. The CCM includes six
addressing psychosocial issues (25,26);
A1C nationally among people with diabe- core elements to optimize the care of and identifying, developing, and engaging
tes declined from 7.6% (60 mmol/mol) patients with chronic disease: community resources and public policies
in 1999–2002 to 7.2% (55 mmol/mol) that support healthy lifestyles (27). The
in 2007–2010 based on the National 1. Delivery system design (moving from National Diabetes Education Program
Health and Nutrition Examination Survey a reactive to a proactive care delivery maintains an online resource (www
(NHANES), with younger adults less likely system where planned visits are .betterdiabetescare.nih.gov) to help health
to meet treatment targets than older coordinated through a team-based care professionals design and implement
adults (3). This has been accompanied approach) more effective health care delivery systems
by improvements in cardiovascular out- 2. Self-management support for those with diabetes.
comes and has led to substantial re- 3. Decision support (basing care on The care team, which centers around
ductions in end-stage microvascular evidence-based, effective care the patient, should avoid therapeutic
complications. guidelines) inertia and prioritize timely and appro-
Nevertheless, 33–49% of patients still 4. Clinical information systems (using priate intensification of lifestyle and/or
did not meet general targets for glyce- registries that can provide patient- pharmacologic therapy for patients who
mic, blood pressure, or cholesterol con- specific and population-based sup- have not achieved the recommended
trol, and only 14% met targets for all port to the care team) metabolic targets (28–30). Strategies
three measures while also avoiding smok- 5. Community resources and policies shown to improve care team behavior
ing (3). Evidence suggests that progress in (identifying or developing resources and thereby catalyze reductions in A1C,
cardiovascular risk factor control (partic- to support healthy lifestyles) blood pressure, and/or LDL cholesterol
ularly tobacco use) may be slowing (3,4). 6. Health systems (to create a quality- include engaging in explicit and collab-
Certain segments of the population, such oriented culture) orative goal setting with patients (31,32);
as young adults and patients with complex identifying and addressing language,
comorbidities, financial or other social Redefining the roles of the health care numeracy, or cultural barriers to care
hardships, and/or limited English pro- delivery team and empowering patient (33–35); integrating evidence-based guide-
ficiency, face particular challenges to self-management are fundamental to lines and clinical information tools
goal-based care (5–7). Even after adjust- the successful implementation of the into the process of care (16,36,37);
ing for these patient factors, the persis- CCM (10). Collaborative, multidisciplinary soliciting performance feedback, setting
tent variability in the quality of diabetes teams are best suited to provide care reminders, and providing structured care
care across providers and practice set- for people with chronic conditions such (e.g., guidelines, formal case manage-
tings indicates that substantial system- as diabetes and to facilitate patients’ ment, and patient education resources)
level improvements are still needed. self-management (11–13). (7); and incorporating care management
Diabetes poses a significant financial teams including nurses, dietitians, phar-
burden to individuals and society. It is Strategies for System-Level Improvement macists, and other providers (17,38).
estimated that the annual cost of di- Optimal diabetes management requires Initiatives such as the Patient-Centered
agnosed diabetes in 2017 was $327 an organized, systematic approach and Medical Home show promise for im-
billion, including $237 billion in direct the involvement of a coordinated team of proving health outcomes by fostering
medical costs and $90 billion in reduced dedicated health care professionals work- comprehensive primary care and offer-
productivity. After adjusting for inflation, ing in an environment where patient- ing new opportunities for team-based
economic costs of diabetes increased centered high-quality care is a priority chronic disease management (39).
by 26% from 2012 to 2017 (8). This is (7,14,15). While many diabetes pro- Telemedicine is a growing field that
attributed to the increased prevalence cesses of care have improved nationally may increase access to care for patients
of diabetes and the increased cost per in the past decade, the overall quality of with diabetes. Telemedicine is defined
person with diabetes. Ongoing population care for patients with diabetes remains as the use of telecommunications to
care.diabetesjournals.org Improving Care and Promoting Health S9

facilitate remote delivery of health-re- barriers to medication taking may be accommodate personalized care goals
lated services and clinical information achieved if the patient and provider (7,57).
(40). A growing body of evidence sug- agree on a targeted approach for a spe-
gests that various telemedicine modali- cific barrier (12). TAILORING TREATMENT FOR
ties may be effective at reducing A1C in SOCIAL CONTEXT
The Affordable Care Act has resulted
patients with type 2 diabetes compared in increased access to care for many Recommendations
with usual care or in addition to usual individuals with diabetes with an empha- 1.5 Providers should assess social
care (41). For rural populations or those sis on the protection of people with context, including potential
with limited physical access to health preexisting conditions, health promotion, food insecurity, housing stabil-
care, telemedicine has a growing body of and disease prevention (45). In fact, health ity, and financial barriers, and
evidence for its effectiveness, particularly insurance coverage increased from apply that information to treat-
with regard to glycemic control as mea- 84.7% in 2009 to 90.1% in 2016 for ment decisions. A
sured by A1C (42–44). Interactive strat- adults with diabetes aged 18–64 years. 1.6 Refer patients to local commu-
egies that facilitate communication Coverage for those $65 years remained nity resources when available. B
between providers and patients, including near universal (46). Patients who have 1.7 Provide patients with self-
the use of web-based portals or text either private or public insurance coverage management support from lay
messaging and those that incorporate are more likely to meet quality indicators health coaches, navigators, or
medication adjustment, appear more for diabetes care (47). As mandated community health workers
effective. There is limited data avail- by the Affordable Care Act, the Agency when available. A
able on the cost-effectiveness of these for Healthcare Research and Quality
strategies. developed a National Quality Strategy
Successful diabetes care also requires based on the triple aims that include Health inequities related to diabetes
a systematic approach to supporting improving the health of a population, and its complications are well docu-
patients’ behavior change efforts. overall quality and patient experience of mented and are heavily influenced by
High-quality diabetes self-management care, and per capita cost (48,49). As social determinants of health (58–62).
education and support (DSMES) has health care systems and practices adapt Social determinants of health are defined
been shown to improve patient self- to the changing landscape of health as the economic, environmental, politi-
management, satisfaction, and glucose care, it will be important to integrate cal, and social conditions in which people
outcomes. National DSMES standards traditional disease-specific metrics with live and are responsible for a major part
call for an integrated approach that in- measures of patient experience, as well of health inequality worldwide (63). The
cludes clinical content and skills, behav- as cost, in assessing the quality of diabe- ADA recognizes the association between
ioral strategies (goal setting, problem tes care (50,51). Information and guid- social and environmental factors and the
solving), and engagement with psycho- ance specific to quality improvement and prevention and treatment of diabetes
social concerns (26). For more informa- practice transformation for diabetes care and has issued a call for research that
tion on DSMES, see Section 5 “Lifestyle is available from the National Diabetes seeks to better understand how these
Management.” Education Program practice transforma- social determinants influence behaviors
In devising approaches to support tion website and the National Institute of and how the relationships between these
disease self-management, it is notable Diabetes and Digestive and Kidney Dis- variables might be modified for the pre-
that in 23% of cases, uncontrolled A1C, eases report on diabetes care and quality vention and management of diabetes
blood pressure, or lipids were associated (52,53). Using patient registries and elec- (64). While a comprehensive strategy to
with poor medication-taking behaviors tronic health records, health systems reduce diabetes-related health inequi-
(“medication adherence”) (19). At a sys- can evaluate the quality of diabetes care ties in populations has not been for-
tem level, “adequate” medication taking being delivered and perform interven- mally studied, general recommendations
is defined as 80% (calculated as the tion cycles as part of quality improve- from other chronic disease models can
number of pills taken by the patient ment strategies (54). Critical to these be drawn upon to inform systems-level
in a given time period divided by the efforts is provider adherence to clinical strategies in diabetes. For example, the
number of pills prescribed by the physi- practice recommendations and accu- National Academy of Medicine has
cian in that same time period) (19). rate, reliable data metrics that include published a framework for educating
If medication taking is 80% or above sociodemographic variables to examine health care professionals on the impor-
and treatment goals are not met, then health equity within and across popula- tance of social determinants of health
treatment intensification should be tions (55). (65). Furthermore, there are resources
considered (e.g., uptitration). Barriers In addition to quality improvement available for the inclusion of standard-
to medication taking may include efforts, other strategies that simulta- ized sociodemographic variables in elec-
patient factors (financial limitations, neously improve the quality of care tronic medical records to facilitate the
remembering to obtain or take medica- and potentially reduce costs are gaining measurement of health inequities as
tions, fear, depression, or health beliefs), momentum and include reimbursement well as the impact of interventions de-
medication factors (complexity, multiple structures that, in contrast to visit-based signed to reduce those inequities (66–68).
daily dosing, cost, or side effects), and billing, reward the provision of appro- Social determinants of health are not
system factors (inadequate follow- priate and high-quality care to achieve always recognized and often go undis-
up or support). Success in overcoming metabolic goals (56) and incentives that cussed in the clinical encounter (61). A
S10 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019

study by Piette et al. (69) found that to get more.” An affirmative response Standards for Culturally and Linguisti-
among patients with chronic illnesses, to either statement had a sensitivity of cally Appropriate Services in Health
two-thirds of those who reported not 97% and specificity of 83%. and Health Care provide guidance on
taking medications as prescribed due to Treatment Considerations how health care providers can reduce
cost never shared this with their physi- In those with diabetes and FI, the priority language barriers by improving their
cian. In a more recent study using data is mitigating the increased risk for un- cultural competency, addressing health
from the National Health Interview controlled hyperglycemia and severe hy- literacy, and ensuring communication
Survey (NHIS), Patel et al. (61) found poglycemia. Reasons for the increased with language assistance (76). The site
that half of adults with diabetes reported risk of hyperglycemia include the steady offers a number of resources and materi-
financial stress and one-fifth reported consumption of inexpensive carbohy- als that can be used to improve the quality
food insecurity (FI). One population in drate-rich processed foods, binge eat- of care delivery to non-English–speaking
which such issues must be considered is ing, financial constraints to the filling patients.
older adults, where social difficulties may of diabetes medication prescriptions, Community Support
impair their quality of life and increase and anxiety/depression leading to poor Identification or development of com-
their risk of functional dependency (70) diabetes self-care behaviors. Hypoglyce- munity resources to support healthy
(see Section 12 “Older Adults” for a de- mia can occur as a result of inadequate lifestyles is a core element of the CCM
tailed discussion of social considerations or erratic carbohydrate consumption (9). Health care community linkages
in older adults). Creating systems-level following the administration of sul- are receiving increasing attention from
mechanisms to screen for social deter- fonylureas or insulin. See Table 9.1 for the American Medical Association, the
minants of health may help overcome drug-specific and patient factors, includ- Agency for Healthcare Research and
structural barriers and communication ing cost and risk of hypoglycemia, for Quality, and others as a means of pro-
gaps between patients and providers treatment options for adults with FI and moting translation of clinical recommen-
(61). In addition, brief, validated screen- type 2 diabetes. Providers should con- dations for lifestyle modification in real-
ing tools for some social determinants of sider these factors when making treat- world settings (77). Community health
health exist and could facilitate discus- ment decisions in people with FI and workers (CHWs) (78), peer supporters
sion around factors that significantly seek local resources that might help (79–81), and lay leaders (82) may assist
impact treatment during the clinical en- patients with diabetes and their family in the delivery of DSMES services (66),
counter. Below is a discussion of assess- members to more regularly obtain particularly in underserved communi-
ment and treatment considerations in nutritious food (74). ties. A CHW is defined by the American
the context of FI, homelessness, and
Public Health Association as a “frontline
limited English proficiency/low literacy. Homelessness public health worker who is a trusted
Homelessness often accompanies many member of and/or has an unusually close
Food Insecurity additional barriers to diabetes self- understanding of the community served”
FI is the unreliable availability of nutri- management, including FI, literacy and (83). CHWs can be part of a cost-effective,
tious food and the inability to consis- numeracy deficiencies, lack of insurance, evidence-based strategy to improve
tently obtain food without resorting to cognitive dysfunction, and mental health the management of diabetes and car-
socially unacceptable practices. Over issues. Additionally, patients with diabe- diovascular risk factors in underserved
14% (or one of every seven people) tes who are homeless need secure places communities and health care systems
of the U.S. population is food insecure. to keep their diabetes supplies and re- (84).
The rate is higher in some racial/ethnic frigerator access to properly store their
minority groups, including African insulin and take it on a regular schedule.
American and Latino populations, in References
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approaches for improving quality and addressing Pandiscio JC, Park ER. Diabetes oral medication Care 2018;41:956–962
disparities. Curr Diab Rep 2017;17:31 initiation and intensification: patient views com- 47. Doucette ED, Salas J, Scherrer JF. Insurance
16. O’Connor PJ, Bodkin NL, Fradkin J, et al. pared with current treatment guidelines. Diabe- coverage and diabetes quality indicators among
Diabetes performance measures: current status tes Educ 2011;37:78–84 patients in NHANES. Am J Manag Care 2016;22:
and future directions. Diabetes Care 2011;34: 32. Tamhane S, Rodriguez-Gutierrez R, Hargraves 484–490
1651–1659 I, Montori VM. Shared decision-making in diabe- 48. Stiefel M, Nolan K. Measuring the triple aim:
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2013;310:699–705 diabetic patients who have low health literacy. About the National Quality Strategy [Internet],
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care beneficiaries: 15 randomized trials. JAMA culturally tailored diabetes self-management 50. National Quality Forum. Home page [Internet],
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Konieczny JL, Steiner JF. Standardizing terminol- 844 51. Burstin H, Johnson K. Getting to better care
ogy and definitions of medication adherence 35. Osborn CY, Cavanaugh K, Wallston KA, et al. and outcomes for diabetes through measure-
and persistence in research employing electronic Health literacy explains racial disparities in di- ment [article online], 2016. Available from
databases. Med Care 2013;51(Suppl. 3):S11–S21 abetes medication adherence. J Health Commun http://www.ajmc.com/journals/evidence-based-
20. Feifer C, Nemeth L, Nietert PJ, et al. Different 2011;16(Suppl. 3):268–278 diabetes-management/2016/march-2016/getting-
paths to high-quality care: three archetypes of 36. Garg AX, Adhikari NKJ, McDonald H, et al. to-better-care-and-outcomes-for-diabetes-through-
top-performing practice sites. Ann Fam Med Effects of computerized clinical decision support measurement. Accessed 22 October 2018
2007;5:233–241 systems on practitioner performance and patient 52. National Institute of Diabetes and Diges-
21. Reed M, Huang J, Graetz I, et al. Outpatient outcomes: a systematic review. JAMA 2005;293: tive and Kidney Diseases. Practice transformation
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and outcomes of patients with diabetes mellitus. 37. Smith SA, Shah ND, Bryant SC, et al.; Evidens Available from https://www.niddk.nih.gov/
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53. National Institute of Diabetes and Digestive 64. Hill JO, Galloway JM, Goley A, et al. Socio- 74. Seligman HK, Schillinger D. Hunger and
and Kidney Diseases. Diabetes care and quality: ecological determinants of prediabetes and socioeconomic disparities in chronic disease.
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https://www.niddk.nih.gov/health-information/ 2439 75. Montgomery AE, Fargo JD, Kane V, Culhane
health-communication-programs/ndep/health- 65. National Academies of Sciences, Engineer- DP. Development and validation of an instrument
care-professionals/practice-transformation/ ing, and Medicine. A Framework to Address to assess imminent risk of homelessness among
defining-quality-care/diabetes-care-quality/Pages/ the Social Determinants of Health [Internet], veterans. Public Health Rep 2014;129:428–436
default.aspx. Accessed 22 October 2018 2016. Washington, DC, The National Academies 76. U.S. Department of Health and Human Ser-
54. O’Connor PJ, Sperl-Hillen JM, Fazio CJ, Press. Available from https://www.nap.edu/ vices. Think cultural health [Internet]. Available
Averbeck BM, Rank BH, Margolis KL. Outpatient catalog/21923/a-framework-for-educating-health- from https://www.thinkculturalhealth.hhs.gov/.
diabetes clinical decision support: current status and professionals-to-address-the-social-determinants- Accessed 22 October 2018
future directions. Diabet Med 2016;33:734–741 of-health. Accessed 22 October 2018 77. Agency for Healthcare Research and Quality.
55. Centers for Medicare & Medicaid Services. 66. Institute of Medicine. Capturing social and Clinical-community linkages [Internet]. Avail-
CMS Equity Plan for Medicare [Internet]. Avail- behavioral domains and measures in electronic able from http://www.ahrq.gov/professionals/
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Agency-Information/OMH/equity-initiatives/ ington, DC, The National Academies Press. Avail- index.html. Accessed 22 October 2018
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56. Rosenthal MB, Cutler DM, Feder J. The ACO capturing-social-and-behavioral-domains-and- community health workers in diabetes: update on
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transformative potential. N Engl J Med 2011;365:e6 22 October 2018 79. Heisler M, Vijan S, Makki F, Piette JD. Di-
57. Washington AE, Lipstein SH. The Patient- 67. Chin MH, Clarke AR, Nocon RS, et al. A abetes control with reciprocal peer support
Centered Outcomes Research Institute–promoting roadmap and best practices for organizations versus nurse care management: a randomized
better information, decisions, and health. N Engl J to reduce racial and ethnic disparities in health trial. Ann Intern Med 2010;153:507–515
Med 2011;365:e31 care. J Gen Intern Med 2012;27:992–1000 80. Long JA, Jahnle EC, Richardson DM,
58. Hutchinson RN, Shin S. Systematic review of 68. National Quality Forum. National voluntary Loewenstein G, Volpp KG. Peer mentoring
health disparities for cardiovascular diseases and consensus standards for ambulatory cared and financial incentives to improve glucose
associated factors among American Indian and measuring healthcare disparities [Internet], 2008. control in African American veterans: a random-
Alaska Native populations. PLoS One 2014;9: Available from https://www.qualityforum.org/ ized trial. Ann Intern Med 2012;156:416–424
e80973 Publications/2008/03/National_Voluntary_ 81. Fisher EB, Boothroyd RI, Elstad EA, et al. Peer
59. Borschuk AP, Everhart RS. Health disparities Consensus_Standards_for_Ambulatory_Care% support of complex health behaviors in preven-
among youth with type 1 diabetes: a systematic E2%80%94Measuring_Healthcare_Disparities tion and disease management with special ref-
review of the current literature. Fam Syst Health .aspx. Accessed 22 October 2018 erence to diabetes: systematic reviews. Clin
2015;33:297–313 69. Piette JD, Heisler M, Wagner TH. Cost- Diabetes Endocrinol 2017;3:4
60. Walker RJ, Strom Williams J, Egede LE. In- related medication underuse among chronically 82. Foster G, Taylor SJC, Eldridge SE, Ramsay J,
fluence of race, ethnicity and social determinants ill adults: the treatments people forgo, how Griffiths CJ. Self-management education pro-
of health on diabetes outcomes. Am J Med Sci often, and who is at risk. Am J Public Health grammes by lay leaders for people with chronic
2016;351:366–373 2004;94:1782–1787 conditions. Cochrane Database Syst Rev 2007;4:
61. Patel MR, Piette JD, Resnicow K, Kowalski- 70. Laiteerapong N, Karter AJ, Liu JY, et al. CD005108
Dobson T, Heisler M. Social determinants of Correlates of quality of life in older adults 83. Rosenthal EL, Rush CH, Allen CG; Project on
health, cost-related nonadherence, and cost- with diabetes: the Diabetes & Aging Study. Di- CHW Policy & Practice. Understanding scope
reducing behaviors among adults with diabetes: abetes Care 2011;34:1749–1753 and competencies: a contemporary look at the
findings from the National Health Interview 71. Heerman WJ, Wallston KA, Osborn CY, et al. United States community health worker field:
Survey. Med Care 2016;54:796–803 Food insecurity is associated with diabetes self- progress report of the Community Health Worker
62. Steve SL, Tung EL, Schlichtman JJ, Peek ME. care behaviours and glycaemic control. Diabet (CHW) Core Consensus (C3) Project: building
Social disorder in adults with type 2 diabetes: Med 2016;33:844–850 national consensus on CHW core roles, skills,
building on race, place, and poverty. Curr Diab 72. Silverman J, Krieger J, Kiefer M, Hebert P, and qualities [Internet], 2016. Available from
Rep 2016;16:72 Robinson J, Nelson K. The relationship between http://files.ctctcdn.com/a907c850501/1c1289f0-
63. World Health Organization Commission on food insecurity and depression, diabetes distress 88cc-49c3-a238-66def942c147.pdf. Accessed
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.pdf. Accessed 22 October 2018 diatrics 2010;126:e26–e32 diabetes. Accessed 22 October 2018
Diabetes Care Volume 42, Supplement 1, January 2019 S13

2. Classification and Diagnosis of American Diabetes Association

Diabetes: Standards of Medical


Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S13–S28 | https://doi.org/10.2337/dc19-S002

2. CLASSIFICATION AND DIAGNOSIS OF DIABETES


The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”
includes ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee, are responsible for updating the Standards of
Care annually, or more frequently as warranted. For a detailed description of ADA
standards, statements, and reports, as well as the evidence-grading system for
ADA’s clinical practice recommendations, please refer to the Standards of Care
Introduction. Readers who wish to comment on the Standards of Care are invited
to do so at professional.diabetes.org/SOC.

CLASSIFICATION
Diabetes can be classified into the following general categories:

1. Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute


insulin deficiency)
2. Type 2 diabetes (due to a progressive loss of b-cell insulin secretion frequently on
the background of insulin resistance)
3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third
trimester of pregnancy that was not clearly overt diabetes prior to gestation)
4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes
(such as neonatal diabetes and maturity-onset diabetes of the young [MODY]),
diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and
drug- or chemical-induced diabetes (such as with glucocorticoid use, in the
treatment of HIV/AIDS, or after organ transplantation)

This section reviews most common forms of diabetes but is not comprehensive. For
additional information, see the American Diabetes Association (ADA) position
statement “Diagnosis and Classification of Diabetes Mellitus” (1).
Type 1 diabetes and type 2 diabetes are heterogeneous diseases in which clinical Suggested citation: American Diabetes Associa-
presentation and disease progression may vary considerably. Classification is im- tion. 2. Classification and diagnosis of diabetes:
portant for determining therapy, but some individuals cannot be clearly classified as Standards of Medical Care in Diabetesd2019.
having type 1 or type 2 diabetes at the time of diagnosis. The traditional paradigms of Diabetes Care 2019;42(Suppl. 1):S13–S28
type 2 diabetes occurring only in adults and type 1 diabetes only in children are no © 2018 by the American Diabetes Association.
longer accurate, as both diseases occur in both age-groups. Children with type 1 Readers may use this article as long as the work
is properly cited, the use is educational and not
diabetes typically present with the hallmark symptoms of polyuria/polydipsia, and for profit, and the work is not altered. More infor-
approximately one-third present with diabetic ketoacidosis (DKA) (2). The onset of mation is available at http://www.diabetesjournals
type 1 diabetes may be more variable in adults, and they may not present with the .org/content/license.
S14 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

classic symptoms seen in children. Oc- of subtypes of this heterogeneous dis- Fasting and 2-Hour Plasma Glucose
casionally, patients with type 2 diabetes order have been developed and vali- The FPG and 2-h PG may be used to
may present with DKA, particularly ethnic dated in Scandinavian and Northern diagnose diabetes (Table 2.2). The con-
minorities (3). Although difficulties in European populations but have not cordance between the FPG and 2-h PG
distinguishing diabetes type may occur in been confirmed in other ethnic and racial tests is imperfect, as is the concordance
all age-groups at onset, the true diag- groups. Type 2 diabetes is primarily as- between A1C and either glucose-based
nosis becomes more obvious over sociated with insulin secretory defects test. Compared with FPG and A1C cut
time. related to inflammation and metabolic points, the 2-h PG value diagnoses more
In both type 1 and type 2 diabetes, stress among other contributors, includ- people with prediabetes and diabetes (9).
various genetic and environmental fac- ing genetic factors. Future classification
A1C
tors can result in the progressive loss of schemes for diabetes will likely focus
b-cell mass and/or function that mani- on the pathophysiology of the underly- Recommendations
fests clinically as hyperglycemia. Once ing b-cell dysfunction and the stage of 2.1 To avoid misdiagnosis or missed
hyperglycemia occurs, patients with all disease as indicated by glucose status diagnosis, the A1C test should be
forms of diabetes are at risk for devel- (normal, impaired, or diabetes) (4). performed using a method that is
oping the same chronic complications, certified by the NGSP and stan-
although rates of progression may differ. DIAGNOSTIC TESTS FOR DIABETES dardized to the Diabetes Control
The identification of individualized ther- Diabetes may be diagnosed based on and Complications Trial (DCCT)
apies for diabetes in the future will re- plasma glucose criteria, either the fasting assay. B
quire better characterization of the many plasma glucose (FPG) value or the 2-h 2.2 Marked discordance between mea-
paths to b-cell demise or dysfunction (4). plasma glucose (2-h PG) value during a sured A1C and plasma glucose
Characterization of the underlying 75-g oral glucose tolerance test (OGTT), levels should raise the possibility
pathophysiology is more developed in or A1C criteria (6) (Table 2.2). of A1C assay interference due to
type 1 diabetes than in type 2 diabetes. It Generally, FPG, 2-h PG during 75-g hemoglobin variants (i.e., hemo-
is now clear from studies of first-degree OGTT, and A1C are equally appropriate globinopathies) and consider-
relatives of patients with type 1 diabetes for diagnostic testing. It should be noted ation of using an assay without
that the persistent presence of two or that the tests do not necessarily detect interference or plasma blood glu-
more autoantibodies is an almost certain diabetes in the same individuals. The cose criteria to diagnose diabe-
predictor of clinical hyperglycemia and efficacy of interventions for primary pre- tes. B
diabetes. The rate of progression is de- vention of type 2 diabetes (7,8) has 2.3 In conditions associated with an
pendent on the age at first detection primarily been demonstrated among in- altered relationship between A1C
of antibody, number of antibodies, anti- dividuals who have impaired glucose and glycemia, such as sickle cell
body specificity, and antibody titer. Glu- tolerance (IGT) with or without elevated disease, pregnancy (second and
cose and A1C levels rise well before the fasting glucose, not for individuals with third trimesters and the postpar-
clinical onset of diabetes, making diag- isolated impaired fasting glucose (IFG) or tum period), glucose-6-phosphate
nosis feasible well before the onset of for those with prediabetes defined by dehydrogenase deficiency, HIV,
DKA. Three distinct stages of type 1 di- A1C criteria. hemodialysis, recent blood loss or
abetes can be identified (Table 2.1) and The same tests may be used to screen transfusion, or erythropoietin ther-
serve as a framework for future research for and diagnose diabetes and to detect apy, only plasma blood glucose cri-
and regulatory decision making (4,5). individuals with prediabetes. Diabetes teria should be used to diagnose
The paths to b-cell demise and dys- may be identified anywhere along the diabetes. B
function are less well defined in type 2 spectrum of clinical scenarios: in seem-
diabetes, but deficient b-cell insulin ingly low-risk individuals who happen to The A1C test should be performed using a
secretion, frequently in the setting of have glucose testing, in individuals tested method that is certified by the NGSP
insulin resistance, appears to be the based on diabetes risk assessment, and (www.ngsp.org) and standardized or
common denominator. Characterization in symptomatic patients. traceable to the Diabetes Control and

Table 2.1—Staging of type 1 diabetes (4,5)


Stage 1 Stage 2 Stage 3
Characteristics c Autoimmunity c Autoimmunity c New-onset hyperglycemia
c Normoglycemia c Dysglycemia c Symptomatic
c Presymptomatic c Presymptomatic
Diagnostic criteria c Multipleautoantibodies c Multiple autoantibodies c Clinical symptoms
c No IGT or IFG c Dysglycemia: IFG and/or IGT c Diabetes by standard criteria
c FPG 100–125 mg/dL (5.6–6.9 mmol/L)
c 2-h PG 140–199 mg/dL (7.8–11.0 mmol/L)
c A1C 5.7–6.4% (39–47 mmol/mol) or $10%
increase in A1C
care.diabetesjournals.org Classification and Diagnosis of Diabetes S15

Table 2.2—Criteria for the diagnosis of diabetes


FPG $126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.*
OR
2-h PG $200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the
equivalent of 75-g anhydrous glucose dissolved in water.*
OR
A1C $6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized
to the DCCT assay.*
OR
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose $200 mg/dL (11.1 mmol/L).
*In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test samples.

Complications Trial (DCCT) reference clinical guidance concluded that A1C, Americans may also have higher levels of
assay. Although point-of-care A1C assays FPG, or 2-h PG can be used to test for fructosamine and glycated albumin and
may be NGSP certified or U.S. Food and prediabetes or type 2 diabetes in chil- lower levels of 1,5-anhydroglucitol, suggest-
Drug Administration approved for diag- dren and adolescents. (see p. S20 SCREEN- ing that their glycemic burden (particularly
nosis, proficiency testing is not always ING AND TESTING FOR PREDIABETES AND TYPE 2 postprandially) may be higher (21,22). The
mandated for performing the test. There- DIABETES IN CHILDREN AND ADOLESCENTS for ad- association of A1C with risk for complica-
fore, point-of-care assays approved for ditional information) (13). tions appears to be similar in African Amer-
diagnostic purposes should only be con- icans and non-Hispanic whites (23,24).
sidered in settings licensed to perform Race/Ethnicity/Hemoglobinopathies
Hemoglobin variants can interfere with Other Conditions Altering the Relationship
moderate-to-high complexity tests. As
of A1C and Glycemia
discussed in Section 6 “Glycemic Targets,” the measurement of A1C, although most
point-of-care A1C assays may be more assays in use in the U.S. are unaffected by In conditions associated with increased
generally applied for glucose monitoring. the most common variants. Marked dis- red blood cell turnover, such as sickle cell
The A1C has several advantages com- crepancies between measured A1C and disease, pregnancy (second and third
pared with the FPG and OGTT, including plasma glucose levels should prompt trimesters), glucose-6-phosphate dehy-
greater convenience (fasting not re- consideration that the A1C assay may drogenase deficiency (25,26), hemodialy-
quired), greater preanalytical stability, not be reliable for that individual. For sis, recent blood loss or transfusion, or
and less day-to-day perturbations during patients with a hemoglobin variant but erythropoietin therapy, only plasma blood
stress and illness. However, these ad- normal red blood cell turnover, such as glucose criteria should be used to diagnose
vantages may be offset by the lower those with the sickle cell trait, an A1C diabetes (27). A1C is less reliable than
sensitivity of A1C at the designated cut assay without interference from hemo- blood glucose measurement in other con-
point, greater cost, limited availability of globin variants should be used. An up- ditions such as postpartum (28–30), HIV
A1C testing in certain regions of the de- dated list of A1C assays with interferences treated with certain drugs (11), and iron-
veloping world, and the imperfect corre- is available at www.ngsp.org/interf.asp. deficient anemia (31).
lation between A1C and average glucose African Americans heterozygous for
in certain individuals. The A1C test, with the common hemoglobin variant HbS Confirming the Diagnosis
a diagnostic threshold of $6.5% (48 may have, for any given level of mean Unless there is a clear clinical diagnosis
mmol/mol), diagnoses only 30% of the glycemia, lower A1C by about 0.3% than (e.g., patient in a hyperglycemic crisis
diabetes cases identified collectively those without the trait (14). Another ge- or with classic symptoms of hyperglyce-
using A1C, FPG, or 2-h PG, according netic variant, X-linked glucose-6-phosphate mia and a random plasma glucose $200
to National Health and Nutrition Exam- dehydrogenase G202A, carried by 11% mg/dL [11.1 mmol/L]), diagnosis requires
ination Survey (NHANES) data (10). of African Americans, was associated two abnormal test results from the
When using A1C to diagnose diabetes, with a decrease in A1C of about 0.8% same sample (32) or in two separate
it is important to recognize that A1C is an in homozygous men and 0.7% in homo- test samples. If using two separate test
indirect measure of average blood glu- zygous women compared with those samples, it is recommended that the
cose levels and to take other factors into without the variant (15). second test, which may either be a repeat
consideration that may impact hemoglo- Even in the absence of hemoglobin of the initial test or a different test, be
bin glycation independently of glycemia variants, A1C levels may vary with race/ performed without delay. For example, if
including HIV treatment (11,12), age, race/ ethnicity independently of glycemia the A1C is 7.0% (53 mmol/mol) and a
ethnicity, pregnancy status, genetic back- (16–18). For example, African Americans repeat result is 6.8% (51 mmol/mol), the
ground, and anemia/hemoglobinopathies. may have higher A1C levels than non- diagnosis of diabetes is confirmed. If two
Hispanic whites with similar fasting and different tests (such as A1C and FPG) are
Age postglucose load glucose levels (19), and both above the diagnostic threshold
The epidemiological studies that formed A1C levels may be higher for a given mean when analyzed from the same sample
the basis for recommending A1C to di- glucose concentration when measured or in two different test samples, this also
agnose diabetes included only adult pop- with continuous glucose monitoring (20). confirms the diagnosis. On the other
ulations (10). However, a recent ADA Though conflicting data exists, African hand, if a patient has discordant results
S16 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

from two different tests, then the test determine how long a patient has had permanent insulinopenia and are prone
result that is above the diagnostic cut hyperglycemia. The criteria to diagnose to DKA, but have no evidence of b-cell
point should be repeated, with consider- diabetes are listed in Table 2.2. autoimmunity. Although only a minority
ation of the possibility of A1C assay in- of patients with type 1 diabetes fall into
terference. The diagnosis is made on the Immune-Mediated Diabetes this category, of those who do, most are of
basis of the confirmed test. For example, This form, previously called “insulin- African or Asian ancestry. Individuals with
if a patient meets the diabetes criterion dependent diabetes” or “juvenile-onset this form of diabetes suffer from episodic
of the A1C (two results $6.5% [48 diabetes,” accounts for 5–10% of diabetes DKA and exhibit varying degrees of insulin
mmol/mol]) but not FPG (,126 mg/dL and is due to cellular-mediated auto- deficiency between episodes. This form
[7.0 mmol/L]), that person should never- immune destruction of the pancreatic of diabetes is strongly inherited and is
theless be considered to have diabetes. b-cells. Autoimmune markers include islet not HLA associated. An absolute require-
Since all the tests have preanalytic and cell autoantibodies and autoantibodies to ment for insulin replacement therapy in
analytic variability, it is possible that an GAD (GAD65), insulin, the tyrosine phos- affected patients may be intermittent.
abnormal result (i.e., above the diagnostic phatases IA-2 and IA-2b, and ZnT8. Type 1
threshold), when repeated, will produce diabetes is defined by the presence of Screening for Type 1 Diabetes Risk
a value below the diagnostic cut point. one or more of these autoimmune The incidence and prevalence of type 1
This scenario is likely for FPG and 2-h PG if markers. The disease has strong HLA diabetes is increasing (33). Patients with
the glucose samples remain at room tem- associations, with linkage to the DQA type 1 diabetes often present with acute
perature and are not centrifuged promptly. and DQB genes. These HLA-DR/DQ alleles symptoms of diabetes and markedly
Because of the potential for preanalytic can be either predisposing or protective. elevated blood glucose levels, and ap-
variability, it is critical that samples for The rate of b-cell destruction is quite proximately one-third are diagnosed
plasma glucose be spun and separated variable, being rapid in some individuals with life-threatening DKA (2). Several
immediately after they are drawn. If pa- (mainly infants and children) and slow in studies indicate that measuring islet
tients have test results near the margins of others (mainly adults). Children and ado- autoantibodies in relatives of those
the diagnostic threshold, the health care lescents may present with DKA as the with type 1 diabetes may identify indi-
professional should follow the patient first manifestation of the disease. Others viduals who are at risk for developing
closely and repeat the test in 3–6 months. have modest fasting hyperglycemia type 1 diabetes (5). Such testing, coupled
that can rapidly change to severe hyper- with education about diabetes symp-
TYPE 1 DIABETES glycemia and/or DKA with infection or toms and close follow-up, may enable
other stress. Adults may retain sufficient earlier identification of type 1 diabetes
Recommendations
b-cell function to prevent DKA for many onset. A study reported the risk of pro-
2.4 Plasma blood glucose rather than gression to type 1 diabetes from the time
years; such individuals eventually be-
A1C should be used to diagnose of seroconversion to autoantibody pos-
come dependent on insulin for survival
the acute onset of type 1 diabetes itivity in three pediatric cohorts from
and are at risk for DKA. At this latter stage
in individuals with symptoms of Finland, Germany, and the U.S. Of the
of the disease, there is little or no insulin
hyperglycemia. E 585 children who developed more than
secretion, as manifested by low or un-
2.5 Screening for type 1 diabetes risk two autoantibodies, nearly 70% devel-
detectable levels of plasma C-peptide.
with a panel of autoantibodies is oped type 1 diabetes within 10 years and
Immune-mediated diabetes commonly
currently recommended only in 84% within 15 years (34). These findings
occurs in childhood and adolescence,
the setting of a research trial or in are highly significant because while the
but it can occur at any age, even in
first-degree family members of a German group was recruited from off-
the 8th and 9th decades of life.
proband with type 1 diabetes. B
Autoimmune destruction of b-cells spring of parents with type 1 diabetes,
2.6 Persistence of two or more auto- the Finnish and American groups were
has multiple genetic predispositions
antibodies predicts clinical diabe- recruited from the general population.
and is also related to environmental
tes and may serve as an indication Remarkably, the findings in all three
factors that are still poorly defined. Al-
for intervention in the setting of groups were the same, suggesting that
though patients are not typically obese
a clinical trial. B the same sequence of events led to
when they present with type 1 diabetes,
obesity should not preclude the diagno- clinical disease in both “sporadic” and
Diagnosis sis. People with type 1 diabetes are also familial cases of type 1 diabetes. Indeed,
In a patient with classic symptoms, mea- prone to other autoimmune disorders the risk of type 1 diabetes increases as
surement of plasma glucose is sufficient such as Hashimoto thyroiditis, Graves dis- the number of relevant autoantibodies
to diagnose diabetes (symptoms of hy- ease, Addison disease, celiac disease, vit- detected increases (35–37).
perglycemia or hyperglycemic crisis plus iligo, autoimmune hepatitis, myasthenia Although there is currently a lack of
a random plasma glucose $200 mg/dL gravis, and pernicious anemia (see Section accepted screening programs, one should
[11.1 mmol/L]). In these cases, knowing 4 “Comprehensive Medical Evaluation consider referring relatives of those with
the plasma glucose level is critical be- and Assessment of Comorbidities”). type 1 diabetes for antibody testing for
cause, in addition to confirming that risk assessment in the setting of a clini-
symptoms are due to diabetes, it will in- Idiopathic Type 1 Diabetes cal research study (www.diabetestrialnet
form management decisions. Some pro- Some forms of type 1 diabetes have no .org). Widespread clinical testing of asymp-
viders may also want to know the A1C to known etiologies. These patients have tomatic low-risk individuals is not currently
care.diabetesjournals.org Classification and Diagnosis of Diabetes S17

recommended due to lack of approved World Health Organization (WHO) and


appropriate, treat other cardio-
therapeutic interventions. Individuals numerous other diabetes organizations
vascular disease risk factors. B
who test positive should be counseled define the IFG cutoff at 110 mg/dL
2.13 Risk-based screening for pre-
about the risk of developing diabetes, (6.1 mmol/L).
diabetes and/or type 2 diabetes
diabetes symptoms, and DKA preven- As with the glucose measures, several
should be considered after the
tion. Numerous clinical studies are be- prospective studies that used A1C to
onset of puberty or after 10 years
ing conducted to test various methods predict the progression to diabetes as
of age, whichever occurs earlier,
of preventing type 1 diabetes in those defined by A1C criteria demonstrated a
in children and adolescents who
with evidence of autoimmunity (www. strong, continuous association between
are overweight (BMI $85th per-
clinicaltrials.gov). A1C and subsequent diabetes. In a sys-
centile) or obese (BMI $95th
tematic review of 44,203 individuals
percentile) and who have addi-
PREDIABETES AND TYPE from 16 cohort studies with a follow-up
tional risk factors for diabe-
2 DIABETES interval averaging 5.6 years (range 2.8–
tes. (See Table 2.4 for evidence
12 years), those with A1C between 5.5
Recommendations grading of risk factors.)
and 6.0% (between 37 and 42 mmol/mol)
2.7 Screening for prediabetes and
had a substantially increased risk of
type 2 diabetes with an infor-
diabetes (5-year incidence from 9 to
mal assessment of risk factors Prediabetes 25%). Those with an A1C range of
or validated tools should be “Prediabetes” is the term used for indi- 6.0–6.5% (42–48 mmol/mol) had a
considered in asymptomatic viduals whose glucose levels do not meet 5-year risk of developing diabetes be-
adults. B the criteria for diabetes but are too high tween 25 and 50% and a relative risk
2.8 Testing for prediabetes and/or to be considered normal (23,24). Pa- 20 times higher compared with A1C of
type 2 diabetes in asymptomatic tients with prediabetes are defined by 5.0% (31 mmol/mol) (41). In a commu-
people should be considered in the presence of IFG and/or IGT and/or nity-based study of African American
adults of any age who are over- A1C 5.7–6.4% (39–47 mmol/mol) (Table and non-Hispanic white adults without
weight or obese (BMI $25 kg/m2 2.5). Prediabetes should not be viewed diabetes, baseline A1C was a stronger
or $23 kg/m2 in Asian Ameri- as a clinical entity in its own right but predictor of subsequent diabetes and
cans) and who have one or more rather as an increased risk for diabetes cardiovascular events than fasting glu-
additional risk factors for diabe- and cardiovascular disease (CVD). Crite- cose (42). Other analyses suggest that A1C
tes (Table 2.3). B ria for testing for diabetes or prediabe- of 5.7% (39 mmol/mol) or higher is asso-
2.9 For all people, testing should be- tes in asymptomatic adults is outlined ciated with a diabetes risk similar to that of
gin at age 45 years. B in Table 2.3. Prediabetes is associated the high-risk participants in the Diabetes
2.10 If tests are normal, repeat testing with obesity (especially abdominal or Prevention Program (DPP) (43), and A1C at
carried out at a minimum of visceral obesity), dyslipidemia with high baseline was a strong predictor of the
3-year intervals is reasonable. C triglycerides and/or low HDL choles- development of glucose-defined diabe-
2.11 To test for prediabetes and terol, and hypertension. tes during the DPP and its follow-up (44).
type 2 diabetes, fasting plasma
Diagnosis Hence, it is reasonable to consider
glucose, 2-h plasma glucose
IFG is defined as FPG levels between an A1C range of 5.7–6.4% (39–47
during 75-g oral glucose toler-
100 and 125 mg/dL (between 5.6 and mmol/mol) as identifying individuals with
ance test, and A1C are equally
6.9 mmol/L) (38,39) and IGT as 2-h PG prediabetes. Similar to those with IFG
appropriate. B
during 75-g OGTT levels between 140 and/or IGT, individuals with A1C of 5.7–
2.12 In patients with prediabetes and
and 199 mg/dL (between 7.8 and 11.0 6.4% (39–47 mmol/mol) should be in-
type 2 diabetes, identify and, if
mmol/L) (40). It should be noted that the formed of their increased risk for diabetes

Table 2.3—Criteria for testing for diabetes or prediabetes in asymptomatic adults


1. Testing should be considered in overweight or obese (BMI $25 kg/m2 or $23 kg/m2 in Asian Americans) adults who have one or more of
the following risk factors:
c First-degree relative with diabetes
c High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander)
c History of CVD
c Hypertension ($140/90 mmHg or on therapy for hypertension)
c HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level .250 mg/dL (2.82 mmol/L)
c Women with polycystic ovary syndrome
c Physical inactivity
c Other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
2. Patients with prediabetes (A1C $5.7% [39 mmol/mol], IGT, or IFG) should be tested yearly.
3. Women who were diagnosed with GDM should have lifelong testing at least every 3 years.
4. For all other patients, testing should begin at age 45 years.
5. If results are normal, testing should be repeated at a minimum of 3-year intervals, with consideration of more frequent testing depending
on initial results and risk status.
S18 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

Table 2.4—Risk-based screening for type 2 diabetes or prediabetes in asymptomatic children and adolescents in a clinical setting
Testing should be considered in youth* who are overweight ($85% percentile) or obese ($95 percentile) A and who have one or more additional
risk factors based on the strength of their association with diabetes:
c Maternal history of diabetes or GDM during the child’s gestation A
c Family history of type 2 diabetes in first- or second-degree relative A
c Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander) A
c Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary
syndrome, or small-for-gestational-age birth weight) B
*After the onset of puberty or after 10 years of age, whichever occurs earlier. If tests are normal, repeat testing at a minimum of 3-year intervals, or
more frequently if BMI is increasing, is recommended.

and CVD and counseled about effective are not known, autoimmune destruction Insulin resistance may improve with
strategies to lower their risks (see Section 3 of b-cells does not occur and patients do weight reduction and/or pharmacologic
“Prevention or Delay of Type 2 Diabetes”). not have any of the other known causes treatment of hyperglycemia but is sel-
Similar to glucose measurements, the con- of diabetes. Most but not all patients dom restored to normal.
tinuum of risk is curvilinear, so as A1C rises, with type 2 diabetes are overweight or The risk of developing type 2 diabetes
the diabetes risk rises disproportionately obese. Excess weight itself causes some increases with age, obesity, and lack of
(41). Aggressive interventions and vig- degree of insulin resistance. Patients physical activity. It occurs more fre-
ilant follow-up should be pursued for who are not obese or overweight by quently in women with prior GDM, in
those considered at very high risk (e.g., traditional weight criteria may have an those with hypertension or dyslipidemia,
those with A1C .6.0% [42 mmol/mol]). increased percentage of body fat distrib- and in certain racial/ethnic subgroups
Table 2.5 summarizes the categories uted predominantly in the abdominal (African American, American Indian,
of prediabetes and Table 2.3 the criteria region. Hispanic/Latino, and Asian American). It
for prediabetes testing. The ADA dia- DKA seldom occurs spontaneously in is often associated with a strong genetic
betes risk test is an additional option type 2 diabetes; when seen, it usually predisposition or family history in first-
for assessment to determine the ap- arises in association with the stress degree relatives, more so than type 1
propriateness of testing for diabetes of another illness such as infection or diabetes. However, the genetics of type 2
or prediabetes in asymptomatic adults. with the use of certain drugs (e.g., diabetes is poorly understood. In adults
(Fig. 2.1) (diabetes.org/socrisktest). For corticosteroids, atypical antipsychotics, without traditional risk factors for
additional background regarding risk fac- and sodium–glucose cotransporter 2 in- type 2 diabetes and/or younger age, con-
tors and screening for prediabetes, see pp. hibitors) (45,46). Type 2 diabetes fre- sider antibody testing to exclude the
S18–S20 (SCREENING AND TESTING FOR PREDIABETES quently goes undiagnosed for many diagnosis of type 1 diabetes (i.e., GAD).
AND TYPE 2 DIABETES IN ASYMPTOMATIC ADULTS and years because hyperglycemia develops
SCREENING AND TESTING FOR PREDIABETES AND TYPE 2 gradually and, at earlier stages, is often Screening and Testing for
DIABETES IN CHILDREN AND ADOLESCENTS). not severe enough for the patient to Prediabetes and Type 2 Diabetes in
notice the classic diabetes symptoms. Asymptomatic Adults
Type 2 Diabetes Nevertheless, even undiagnosed pa- Screening for prediabetes and type 2
Type 2 diabetes, previously referred to tients are at increased risk of develop- diabetes risk through an informal as-
as “noninsulin-dependent diabetes” or ing macrovascular and microvascular sessment of risk factors (Table 2.3) or with
“adult-onset diabetes,” accounts for 90– complications. an assessment tool, such as the ADA risk
95% of all diabetes. This form encom- Whereas patients with type 2 diabetes test (Fig. 2.1) (diabetes.org/socrisktest),
passes individuals who have relative may have insulin levels that appear nor- is recommended to guide providers on
(rather than absolute) insulin deficiency mal or elevated, the higher blood glu- whether performing a diagnostic test
and have peripheral insulin resistance. cose levels in these patients would be (Table 2.2) is appropriate. Prediabetes
At least initially, and often throughout expected to result in even higher insulin and type 2 diabetes meet criteria for
their lifetime, these individuals may not values had their b-cell function been conditions in which early detection is
need insulin treatment to survive. normal. Thus, insulin secretion is defec- appropriate. Both conditions are com-
There are various causes of type 2 di- tive in these patients and insufficient mon and impose significant clinical and
abetes. Although the specific etiologies to compensate for insulin resistance. public health burdens. There is often a
long presymptomatic phase before the
Table 2.5—Criteria defining prediabetes*
diagnosis of type 2 diabetes. Simple tests
FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) to detect preclinical disease are readily
OR available. The duration of glycemic bur-
2-h PG during 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) den is a strong predictor of adverse out-
OR
comes. There are effective interventions
A1C 5.7–6.4% (39–47 mmol/mol)
that prevent progression from prediabe-
tes to diabetes (see Section 3 “Prevention
*For all three tests, risk is continuous, extending below the lower limit of the range and becoming or Delay of Type 2 Diabetes”) and re-
disproportionately greater at the higher end of the range.
duce the risk of diabetes complications
care.diabetesjournals.org Classification and Diagnosis of Diabetes S19

Figure 2.1—ADA risk test (diabetes.org/socrisktest).

(see Section 10 “Cardiovascular Disease of Asian and Hispanic Americans with effectiveness of such screening have
and Risk Management” and Section 11 diabetes are undiagnosed (38,39). Al- not been conducted and are unlikely
“Microvascular Complications and Foot though screening of asymptomatic indi- to occur.
Care”). viduals to identify those with prediabetes A large European randomized con-
Approximately one-quarter of people or diabetes might seem reasonable, trolled trial compared the impact of
with diabetes in the U.S. and nearly half rigorous clinical trials to prove the screening for diabetes and intensive
S20 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

multifactorial intervention with that of (52). The finding that one-third to one- practices had dysglycemia (61). Further
screening and routine care (47). General half of diabetes in Asian Americans is research is needed to demonstrate
practice patients between the ages of undiagnosed suggests that testing is the feasibility, effectiveness, and cost-
40 and 69 years were screened for di- not occurring at lower BMI thresholds effectiveness of screening in this setting.
abetes and randomly assigned by prac- (53,54).
tice to intensive treatment of multiple Evidence also suggests that other pop- Screening and Testing for Prediabetes
risk factors or routine diabetes care. ulations may benefit from lower BMI cut and Type 2 Diabetes in Children and
After 5.3 years of follow-up, CVD risk points. For example, in a large multi- Adolescents
factors were modestly but significantly ethnic cohort study, for an equivalent In the last decade, the incidence and
improved with intensive treatment com- incidence rate of diabetes, a BMI of prevalence of type 2 diabetes in adoles-
pared with routine care, but the inci- 30 kg/m2 in non-Hispanic whites was cents has increased dramatically, es-
dence of first CVD events or mortality equivalent to a BMI of 26 kg/m2 in Afri- pecially in racial and ethnic minority
was not significantly different between can Americans (55). populations (33). See Table 2.4 for rec-
the groups (40). The excellent care pro- ommendations on risk-based screening
Medications
vided to patients in the routine care for type 2 diabetes or prediabetes in
Certain medications, such as glucocorti- asymptomatic children and adolescents
group and the lack of an unscreened
coids, thiazide diuretics, some HIV med- in a clinical setting (13). See Tables 2.2
control arm limited the authors’ ability
ications, and atypical antipsychotics (56), and 2.5 for the criteria for the diagno-
to determine whether screening and
are known to increase the risk of diabetes sis of diabetes and prediabetes, respec-
early treatment improved outcomes com-
and should be considered when deciding tively, which apply to children, adolescents,
pared with no screening and later treat-
whether to screen. and adults. See Section 13 “Children
ment after clinical diagnoses. Computer
simulation modeling studies suggest that Testing Interval and Adolescents” for additional infor-
major benefits are likely to accrue from The appropriate interval between screen- mation on type 2 diabetes in children
the early diagnosis and treatment of ing tests is not known (57). The rationale and adolescents.
hyperglycemia and cardiovascular risk for the 3-year interval is that with this Some studies question the validity of
factors in type 2 diabetes (48); more- interval, the number of false-positive A1C in the pediatric population, espe-
over, screening, beginning at age 30 tests that require confirmatory testing cially among certain ethnicities, and sug-
or 45 years and independent of risk will be reduced and individuals with gest OGTT or FPG as more suitable
factors, may be cost-effective (,$11,000 false-negative tests will be retested diagnostic tests (62). However, many
per quality-adjusted life-year gained) (49). before substantial time elapses and of these studies do not recognize that
Additional considerations regarding complications develop (57). diabetes diagnostic criteria are based on
testing for type 2 diabetes and predia- long-term health outcomes, and valida-
Community Screening
betes in asymptomatic patients include tions are not currently available in the
Ideally, testing should be carried out
the following. pediatric population (63). The ADA ac-
within a health care setting because of
knowledges the limited data supporting
Age the need for follow-up and treatment.
A1C for diagnosing type 2 diabetes in
Age is a major risk factor for diabetes. Community screening outside a health
children and adolescents. Although A1C
Testing should begin at no later than age care setting is generally not recom-
is not recommended for diagnosis of di-
45 years for all patients. Screening should mended because people with positive
abetes in children with cystic fibrosis or
be considered in overweight or obese tests may not seek, or have access to,
symptoms suggestive of acute onset of
adults of any age with one or more risk appropriate follow-up testing and care.
type 1 diabetes and only A1C assays with-
factors for diabetes. However, in specific situations where
out interference are appropriate for chil-
an adequate referral system is estab-
BMI and Ethnicity dren with hemoglobinopathies, the ADA
lished beforehand for positive tests,
In general, BMI $25 kg/m2 is a risk factor continues to recommend A1C for diagnosis
community screening may be consid-
for diabetes. However, data suggest that of type 2 diabetes in this cohort (64,65).
ered. Community testing may also be
the BMI cut point should be lower for
poorly targeted; i.e., it may fail to reach
the Asian American population (50,51). GESTATIONAL DIABETES
the groups most at risk and inappro-
The BMI cut points fall consistently be- MELLITUS
priately test those at very low risk or
tween 23 and 24 kg/m2 (sensitivity of 80%)
even those who have already been Recommendations
for nearly all Asian American subgroups
diagnosed (58). 2.14 Test for undiagnosed diabetes at
(with levels slightly lower for Japanese
the first prenatal visit in those
Americans). This makes a rounded cut Screening in Dental Practices
with risk factors using standard
point of 23 kg/m2 practical. An argument Because periodontal disease is associ-
diagnostic criteria. B
can be made to push the BMI cut point ated with diabetes, the utility of screen-
2.15 Test for gestational diabetes mel-
to lower than 23 kg/m2 in favor of increased ing in a dental setting and referral to
litus at 24–28 weeks of gestation
sensitivity; however, this would lead to primary care as a means to improve the
in pregnant women not previ-
an unacceptably low specificity (13.1%). diagnosis of prediabetes and diabetes
ously known to have diabetes. A
Data from the WHO also suggest that a has been explored (59–61), with one
2.16 Test women with gestational di-
BMI of $23 kg/m2 should be used to study estimating that 30% of patients
abetes mellitus for prediabetes
define increased risk in Asian Americans $30 years of age seen in general dental
care.diabetesjournals.org Classification and Diagnosis of Diabetes S21

(Table 2.3) at their initial prenatal Diagnosis


or diabetes at 4–12 weeks post-
visit, using standard diagnostic criteria GDM carries risks for the mother, fetus,
partum, using the 75-g oral glu-
(Table 2.2). Women diagnosed with di- and neonate. Not all adverse outcomes are
cose tolerance test and clinically
abetes by standard diagnostic criteria of equal clinical importance. The Hyper-
appropriate nonpregnancy diag-
in the first trimester should be classified glycemia and Adverse Pregnancy Out-
nostic criteria. B
as having preexisting pregestational di- come (HAPO) study (74), a large-scale
2.17 Women with a history of gesta-
abetes (type 2 diabetes or, very rarely, multinational cohort study completed
tional diabetes mellitus should
type 1 diabetes or monogenic diabe- by more than 23,000 pregnant women,
have lifelong screening for the
tes). Women found to have prediabetes demonstrated that risk of adverse ma-
development of diabetes or pre-
in the first trimester may be encour- ternal, fetal, and neonatal outcomes
diabetes at least every 3 years. B
aged to make lifestyle changes to reduce continuously increased as a function of
2.18 Women with a history of gesta-
their risk of developing type 2 diabetes, maternal glycemia at 24–28 weeks of ges-
tional diabetes mellitus found to
and perhaps GDM, though more study tation, even within ranges previously con-
have prediabetes should receive
is needed (68). GDM is diabetes that is sidered normal for pregnancy. For most
intensive lifestyle interventions or
first diagnosed in the second or third complications, there was no threshold for
metformin to prevent diabetes. A
trimester of pregnancy that is not clearly risk. These results have led to careful re-
either preexisting type 1 or type 2 di- consideration of the diagnostic criteria for
Definition abetes (see Section 14 “Management GDM. GDM diagnosis (Table 2.6) can be
For many years, GDM was defined as any of Diabetes in Pregnancy”). The Inter- accomplished with either of two strategies:
degree of glucose intolerance that was national Association of the Diabetes
first recognized during pregnancy (40), and Pregnancy Study Groups (IADPSG) 1. “One-step” 75-g OGTT or
regardless of whether the condition GDM diagnostic criteria for the 75-g 2. “Two-step” approach with a 50-g
may have predated the pregnancy or OGTT as well as the GDM screening (nonfasting) screen followed by a
persisted after the pregnancy. This def- and diagnostic criteria used in the two- 100-g OGTT for those who screen
inition facilitated a uniform strategy for step approach were not derived from positive
detection and classification of GDM, but data in the first half of pregnancy, so the
it was limited by imprecision. diagnosis of GDM in early pregnancy by Different diagnostic criteria will identify
The ongoing epidemic of obesity and either FPG or OGTT values is not evidence different degrees of maternal hypergly-
diabetes has led to more type 2 diabetes based (69). cemia and maternal/fetal risk, leading
in women of childbearing age, with an Because GDM confers increased risk some experts to debate, and disagree on,
increase in the number of pregnant for the development of type 2 diabetes optimal strategies for the diagnosis of
women with undiagnosed type 2 dia- after delivery (70,71) and because effec- GDM.
betes (66). Because of the number of tive prevention interventions are avail- One-Step Strategy
pregnant women with undiagnosed type able (72,73), women diagnosed with The IADPSG defined diagnostic cut points
2 diabetes, it is reasonable to test women GDM should receive lifelong screening for GDM as the average fasting, 1-h, and
with risk factors for type 2 diabetes (67) for prediabetes and type 2 diabetes. 2-h PG values during a 75-g OGTT in

Table 2.6—Screening for and diagnosis of GDM


One-step strategy
Perform a 75-g OGTT, with plasma glucose measurement when patient is fasting and at 1 and 2 h, at 24–28 weeks of gestation in women not
previously diagnosed with diabetes.
The OGTT should be performed in the morning after an overnight fast of at least 8 h.
The diagnosis of GDM is made when any of the following plasma glucose values are met or exceeded:
c Fasting: 92 mg/dL (5.1 mmol/L)
c 1 h: 180 mg/dL (10.0 mmol/L)
c 2 h: 153 mg/dL (8.5 mmol/L)
Two-step strategy
Step 1: Perform a 50-g GLT (nonfasting), with plasma glucose measurement at 1 h, at 24–28 weeks of gestation in women not previously diagnosed
with diabetes.
If the plasma glucose level measured 1 h after the load is $130 mg/dL, 135 mg/dL, or 140 mg/dL (7.2 mmol/L, 7.5 mmol/L, or 7.8 mmol/L, respectively),
proceed to a 100-g OGTT.
Step 2: The 100-g OGTT should be performed when the patient is fasting.
The diagnosis of GDM is made if at least two* of the following four plasma glucose levels (measured fasting and 1 h, 2 h, 3 h during OGTT) are met or
exceeded:
Carpenter-Coustan (86) or NDDG (87)
cFasting 95 mg/dL (5.3 mmol/L) 105 mg/dL (5.8 mmol/L)
c1h 180 mg/dL (10.0 mmol/L) 190 mg/dL (10.6 mmol/L)
c2 h 155 mg/dL (8.6 mmol/L) 165 mg/dL (9.2 mmol/L)
c3 h 140 mg/dL (7.8 mmol/L) 145 mg/dL (8.0 mmol/L)
NDDG, National Diabetes Data Group. *ACOG notes that one elevated value can be used for diagnosis (82).
S22 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

women at 24–28 weeks of gestation criteria versus older criteria have been identified by the two-step approach,
who participated in the HAPO study at published to date. Data are also lacking reduces rates of neonatal macrosomia,
which odds for adverse outcomes reached on how the treatment of lower levels large-for-gestational-age births (85), and
1.75 times the estimated odds of these of hyperglycemia affects a mother’s fu- shoulder dystocia, without increasing
outcomes at the mean fasting, 1-h, and ture risk for the development of type 2 small-for-gestational-age births. ACOG
2-h PG levels of the study population. diabetes and her offspring’s risk for currently supports the two-step ap-
This one-step strategy was anticipated obesity, diabetes, and other meta- proach but notes that one elevated
to significantly increase the incidence of bolic disorders. Additional well-designed value, as opposed to two, may be
GDM (from 5–6% to 15–20%), primarily clinical studies are needed to deter- used for the diagnosis of GDM (82). If
because only one abnormal value, not mine the optimal intensity of monitor- this approach is implemented, the in-
two, became sufficient to make the di- ing and treatment of women with GDM cidence of GDM by the two-step strat-
agnosis (75). The anticipated increase in diagnosed by the one-step strategy egy will likely increase markedly.
the incidence of GDM could have a sub- (79,80). ACOG recommends either of two sets of
stantial impact on costs and medical diagnostic thresholds for the 3-h 100-g
infrastructure needs and has the poten- Two-Step Strategy OGTT (86,87). Each is based on different
tial to “medicalize” pregnancies previ- In 2013, the National Institutes of Health mathematical conversions of the original
ously categorized as normal. A recent (NIH) convened a consensus develop- recommended thresholds, which used
follow-up study of women participating ment conference to consider diagnostic whole blood and nonenzymatic methods
in a blinded study of pregnancy OGTTs criteria for diagnosing GDM (81). The for glucose determination. A secondary
found that 11 years after their pregnan- 15-member panel had representatives analysis of data from a randomized clin-
cies, women who would have been from obstetrics/gynecology, maternal- ical trial of identification and treatment
diagnosed with GDM by the one-step ap- fetal medicine, pediatrics, diabetes re- of mild GDM (88) demonstrated that
proach, as compared with those without, search, biostatistics, and other related treatment was similarly beneficial in
were at 3.4-fold higher risk of developing fields. The panel recommended a two- patients meeting only the lower thresh-
prediabetes and type 2 diabetes and had step approach to screening that used a olds (86) and in those meeting only the
children with a higher risk of obesity and 1-h 50-g glucose load test (GLT) followed higher thresholds (87). If the two-step
increased body fat, suggesting that the by a 3-h 100-g OGTT for those who approach is used, it would appear advan-
larger group of women identified by the screened positive. The American Col- tageous to use the lower diagnostic
one-step approach would benefit from lege of Obstetricians and Gynecologists thresholds as shown in step 2 in Table 2.6.
increased screening for diabetes and (ACOG) recommends any of the com-
prediabetes that would accompany a monly used thresholds of 130, 135, or Future Considerations
history of GDM (76). Nevertheless, the 140 mg/dL for the 1-h 50-g GLT (82). A The conflicting recommendations from
ADA recommends these diagnostic cri- systematic review for the U.S. Preventive expert groups underscore the fact that
teria with the intent of optimizing ges- Services Task Force compared GLT cut- there are data to support each strategy.
tational outcomes because these criteria offs of 130 mg/dL (7.2 mmol/L) and A cost-benefit estimation comparing the
were the only ones based on pregnancy 140 mg/dL (7.8 mmol/L) (83). The higher two strategies concluded that the one-
outcomes rather than end points such cutoff yielded sensitivity of 70–88% and step approach is cost-effective only if
as prediction of subsequent maternal specificity of 69–89%, while the lower patients with GDM receive postdelivery
diabetes. cutoff was 88–99% sensitive and 66– counseling and care to prevent type 2
The expected benefits to the off- 77% specific. Data regarding a cutoff diabetes (89). The decision of which
spring are inferred from intervention of 135 mg/dL are limited. As for other strategy to implement must therefore
trials that focused on women with lower screening tests, choice of a cutoff is be made based on the relative values
levels of hyperglycemia than identified based upon the trade-off between sen- placed on factors that have yet to be
using older GDM diagnostic criteria. sitivity and specificity. The use of A1C at measured (e.g., willingness to change
Those trials found modest benefits includ- 24–28 weeks of gestation as a screening practice based on correlation studies
ing reduced rates of large-for-gestational- test for GDM does not function as well rather than intervention trial results,
age births and preeclampsia (77,78). It as the GLT (84). available infrastructure, and importance
is important to note that 80–90% of Key factors cited by the NIH panel in of cost considerations).
women being treated for mild GDM in their decision-making process were the As the IADPSG criteria (“one-step
these two randomized controlled trials lack of clinical trial data demonstrating strategy”) have been adopted interna-
could be managed with lifestyle therapy the benefits of the one-step strategy tionally, further evidence has emerged to
alone. The OGTT glucose cutoffs in these and the potential negative consequences support improved pregnancy outcomes
two trials overlapped with the thresh- of identifying a large group of women with cost savings (90) and may be the
olds recommended by the IADPSG, and with GDM, including medicalization of preferred approach. Data comparing
in one trial (78), the 2-h PG threshold pregnancy with increased health care population-wide outcomes with one-
(140 mg/dL [7.8 mmol/L]) was lower utilization and costs. Moreover, screening step versus two-step approaches have
than the cutoff recommended by the with a 50-g GLT does not require fasting been inconsistent to date (91,92). In
IADPSG (153 mg/dL [8.5 mmol/L]). No and is therefore easier to accomplish addition, pregnancies complicated by
randomized controlled trials of identify- for many women. Treatment of higher- GDM per the IADPSG criteria, but not
ing and treating GDM using the IADPSG threshold maternal hyperglycemia, as recognized as such, have comparable
care.diabetesjournals.org Classification and Diagnosis of Diabetes S23

outcomes to pregnancies diagnosed as weight, height, BMI, or lung function.


2.25 Immunosuppressive regimens
GDM by the more stringent two-step Continuous glucose monitoring or
shown to provide the best out-
criteria (93,94). There remains strong HOMA of b-cell function (96) may be
comes for patient and graft
consensus that establishing a uniform more sensitive than OGTT to detect
survival should be used, irre-
approach to diagnosing GDM will benefit risk for progression to CFRD; how-
spective of posttransplantation
patients, caregivers, and policy makers. ever, evidence linking these results
diabetes mellitus risk. E
Longer-term outcome studies are cur- to long-term outcomes is lacking, and
rently underway. these tests are not recommended for
screening (97). Several terms are used in the literature
CYSTIC FIBROSIS–RELATED CFRD mortality has significantly de- to describe the presence of diabetes
DIABETES creased over time, and the gap in mor- following organ transplantation. “New-
tality between cystic fibrosis patients onset diabetes after transplantation”
Recommendations
with and without diabetes has consid- (NODAT) is one such designation that
2.19 Annual screening for cystic
erably narrowed (98). There are limited describes individuals who develop new-
fibrosis–related diabetes with
clinical trial data on therapy for CFRD. The onset diabetes following transplant.
an oral glucose tolerance test
largest study compared three regimens: NODAT excludes patients with pretrans-
should begin by age 10 years
premeal insulin aspart, repaglinide, or plant diabetes that was undiagnosed
in all patients with cystic fibrosis
oral placebo in cystic fibrosis patients as well as posttransplant hyperglycemia
not previously diagnosed with
with diabetes or abnormal glucose tol- that resolves by the time of discharge
cystic fibrosis–related diabe-
erance. Participants all had weight loss in (103). Another term, “posttransplan-
tes. B
the year preceding treatment; however, tation diabetes mellitus” (PTDM) (103,
2.20 A1C is not recommended as a
in the insulin-treated group, this pat- 104), describes the presence of diabetes
screening test for cystic fibrosis–
tern was reversed, and patients gained in the posttransplant setting irrespec-
related diabetes. B
0.39 (6 0.21) BMI units (P 5 0.02). The tive of the timing of diabetes onset.
2.21 Patients with cystic fibrosis–
repaglinide-treated group had initial Hyperglycemia is very common dur-
related diabetes should be
weight gain, but this was not sustained ing the early posttransplant period, with
treated with insulin to attain in-
by 6 months. The placebo group contin- ;90% of kidney allograft recipients ex-
dividualized glycemic goals. A
ued to lose weight (99). Insulin remains hibiting hyperglycemia in the first few
2.22 Beginning 5 years after the di-
the most widely used therapy for CFRD weeks following transplant (103–106).
agnosis of cystic fibrosis–related
(100). In most cases, such stress- or steroid-
diabetes, annual monitoring for
Additional resources for the clinical induced hyperglycemia resolves by the
complications of diabetes is rec-
management of CFRD can be found in time of discharge (106,107). Although
ommended. E
the position statement “Clinical Care the use of immunosuppressive therapies
Guidelines for Cystic Fibrosis2Related is a major contributor to the develop-
Cystic fibrosis–related diabetes (CFRD) Diabetes: A Position Statement of the ment of PTDM, the risks of transplant
is the most common comorbidity in American Diabetes Association and a Clin- rejection outweigh the risks of PTDM and
people with cystic fibrosis, occurring in ical Practice Guideline of the Cystic Fibrosis the role of the diabetes care provider is
about 20% of adolescents and 40–50% Foundation, Endorsed by the Pediatric to treat hyperglycemia appropriately re-
of adults (95). Diabetes in this popu- Endocrine Society” (101) and in the In- gardless of the type of immunosuppres-
lation, compared with individuals with ternational Society for Pediatric and Ad- sion (103). Risk factors for PTDM include
type 1 or type 2 diabetes, is associated olescent Diabetes’s 2014 clinical practice both general diabetes risks (such as age,
with worse nutritional status, more consensus guidelines (102). family history of diabetes, etc.) as well as
severe inflammatory lung disease, transplant-specific factors, such as use
and greater mortality. Insulin insuffi- POSTTRANSPLANTATION of immunosuppressant agents (108).
ciency is the primary defect in CFRD. DIABETES MELLITUS Whereas posttransplantation hypergly-
Genetically determined b-cell func- cemia is an important risk factor for
Recommendations
tion and insulin resistance associated subsequent PTDM, a formal diagnosis
2.23 Patients should be screened
with infection and inflammation may of PTDM is optimally made once the
after organ transplantation for
also contribute to the development patient is stable on maintenance immu-
hyperglycemia, with a formal
of CFRD. Milder abnormalities of glu- nosuppression and in the absence of
diagnosis of posttransplantation
cose tolerance are even more common acute infection (106–108). The OGTT is
diabetes mellitus being best
and occur at earlier ages than CFRD. considered the gold standard test for
made once a patient is stable
Whether individuals with IGT should be the diagnosis of PTDM (103,104,109,
on an immunosuppressive regi-
treated with insulin replacement has 110). However, screening patients using
men and in the absence of an
not currently been determined. Al- fasting glucose and/or A1C can identify
acute infection. E
though screening for diabetes before high-risk patients requiring further as-
2.24 The oral glucose tolerance test
the age of 10 years can identify risk sessment and may reduce the number
is the preferred test to make
for progression to CFRD in those with of overall OGTTs required.
a diagnosis of posttransplanta-
abnormal glucose tolerance, no benefit Few randomized controlled studies have
tion diabetes mellitus. B
has been established with respect to reported on the short- and long-term
S24 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

use of antihyperglycemic agents in the dose adjustments may be required be-


life should have immediate ge-
setting of PTDM (108,111,112). Most cause of decreases in the glomerular
netic testing for neonatal diabe-
studies have reported that transplant filtration rate, a relatively common com-
tes. A
patients with hyperglycemia and PTDM plication in transplant patients. A small
2.27 Children and adults, diagnosed
after transplantation have higher rates short-term pilot study reported that
in early adulthood, who have
of rejection, infection, and rehospitali- metformin was safe to use in renal trans-
diabetes not characteristic of
zation (106,108,113). plant recipients (114), but its safety has
type 1 or type 2 diabetes that
Insulin therapy is the agent of choice not been determined in other types of
occurs in successive generations
for the management of hyperglycemia organ transplant. Thiazolidinediones have
(suggestive of an autosomal
and diabetes in the hospital setting. Af- been used successfully in patients with
dominant pattern of inheri-
ter discharge, patients with preexisting liver and kidney transplants, but side
tance) should have genetic test-
diabetes could go back on their pre- effects include fluid retention, heart fail-
ing for maturity-onset diabetes
transplant regimen if they were in good ure, and osteopenia (115,116). Dipeptidyl
of the young. A
control before transplantation. Those peptidase 4 inhibitors do not interact with
2.28 In both instances, consulta-
with previously poor control or with per- immunosuppressant drugs and have
tion with a center specializing
sistent hyperglycemia should continue in- demonstrated safety in small clinical trials
in diabetes genetics is recom-
sulin with frequent home self-monitoring (117,118). Well-designed intervention
mended to understand the sig-
of blood glucose to determine when trials examining the efficacy and safety
nificance of these mutations and
insulin dose reductions may be needed of these and other antihyperglycemic
how best to approach further
and when it may be appropriate to switch agents in patients with PTDM are needed.
evaluation, treatment, and ge-
to noninsulin agents.
netic counseling. E
No studies to date have established
which noninsulin agents are safest or MONOGENIC DIABETES
most efficacious in PTDM. The choice SYNDROMES Monogenic defects that cause b-cell dys-
of agent is usually made based on the function, such as neonatal diabetes and
Recommendations
side effect profile of the medication and MODY, represent a small fraction of
2.26 All children diagnosed with di-
possible interactions with the patient’s patients with diabetes (,5%). Table 2.7
abetes in the first 6 months of
immunosuppression regimen (108). Drug describes the most common causes of

Table 2.7—Most common causes of monogenic diabetes (119)


Gene Inheritance Clinical features
MODY
GCK AD GCK-MODY: stable, nonprogressive elevated fasting blood glucose; typically
does not require treatment; microvascular complications are rare; small
rise in 2-h PG level on OGTT (,54 mg/dL [3 mmol/L])
HNF1A AD HNF1A-MODY: progressive insulin secretory defect with presentation in
adolescence or early adulthood; lowered renal threshold for glucosuria;
large rise in 2-h PG level on OGTT (.90 mg/dL [5 mmol/L]); sensitive to
sulfonylureas
HNF4A AD HNF4A-MODY: progressive insulin secretory defect with presentation in
adolescence or early adulthood; may have large birth weight and
transient neonatal hypoglycemia; sensitive to sulfonylureas
HNF1B AD HNF1B-MODY: developmental renal disease (typically cystic); genitourinary
abnormalities; atrophy of the pancreas; hyperuricemia; gout
Neonatal diabetes
KCNJ11 AD Permanent or transient: IUGR; possible developmental delay and seizures;
responsive to sulfonylureas
INS AD Permanent: IUGR; insulin requiring
ABCC8 AD Permanent or transient: IUGR; rarely developmental delay; responsive to
sulfonylureas
6q24 AD for paternal Transient: IUGR; macroglossia; umbilical hernia; mechanisms include UPD6,
(PLAGL1, HYMA1) duplications paternal duplication or maternal methylation defect; may be treatable
with medications other than insulin
GATA6 AD Permanent: pancreatic hypoplasia; cardiac malformations; pancreatic
exocrine insufficiency; insulin requiring
EIF2AK3 AR Permanent: Wolcott-Rallison syndrome: epiphyseal dysplasia; pancreatic
exocrine insufficiency; insulin requiring
FOXP3 X-linked Permanent: immunodysregulation, polyendocrinopathy, enteropathy
X-linked (IPEX) syndrome: autoimmune diabetes; autoimmune thyroid
disease; exfoliative dermatitis; insulin requiring
AD, autosomal dominant; AR, autosomal recessive; IUGR, intrauterine growth restriction.
care.diabetesjournals.org Classification and Diagnosis of Diabetes S25

monogenic diabetes. For a comprehen- considered first-line therapy. Mutations the absence of glucose-lowering ther-
sive list of causes, see Genetic Diagnosis or deletions in HNF1B are associated apy (125). Genetic counseling is re-
of Endocrine Disorders (119). with renal cysts and uterine malforma- commended to ensure that affected
tions (renal cysts and diabetes [RCAD] individuals understand the patterns of
Neonatal Diabetes syndrome). Other extremely rare forms inheritance and the importance of a
Diabetes occurring under 6 months of of MODY have been reported to involve correct diagnosis.
age is termed “neonatal” or “congenital” other transcription factor genes includ- The diagnosis of monogenic diabetes
diabetes, and about 80–85% of cases can ing PDX1 (IPF1) and NEUROD1. should be considered in children and
be found to have an underlying mono- adults diagnosed with diabetes in early
genic cause (120). Neonatal diabetes Diagnosis of Monogenic Diabetes adulthood with the following findings:
occurs much less often after 6 months A diagnosis of one of the three most
of age, whereas autoimmune type 1 di- common forms of MODY, including ○ Diabetes diagnosed within the first
abetes rarely occurs before 6 months GCK-MODY, HNF1A-MODY, and HNF4A- 6 months of life (with occasional cases
of age. Neonatal diabetes can either be MODY, allows for more cost-effective presenting later, mostly INS and
transient or permanent. Transient dia- therapy (no therapy for GCK-MODY; ABCC8 mutations) (120,126)
betes is most often due to overexpres- sulfonylureas as first-line therapy for ○ Diabetes without typical features of
sion of genes on chromosome 6q24, is HNF1A-MODY and HNF4A-MODY). Ad- type 1 or type 2 diabetes (negative
recurrent in about half of cases, and may ditionally, diagnosis can lead to iden- diabetes-associated autoantibodies,
be treatable with medications other than tification of other affected family nonobese, lacking other metabolic
insulin. Permanent neonatal diabetes is members. features especially with strong family
most commonly due to autosomal dom- A diagnosis of MODY should be con- history of diabetes)
inant mutations in the genes encoding the sidered in individuals who have atypical ○ Stable, mild fasting hyperglycemia
Kir6.2 subunit (KCNJ11) and SUR1 subunit diabetes and multiple family members (100–150 mg/dL [5.5–8.5 mmol/L]),
(ABCC8) of the b-cell KATP channel. Correct with diabetes not characteristic of type 1 stable A1C between 5.6 and 7.6%
diagnosis has critical implications because or type 2 diabetes, although admittedly (between 38 and 60 mmol/mol), es-
most patients with KATP-related neonatal “atypical diabetes” is becoming increas- pecially if nonobese
diabetes will exhibit improved glycemic ingly difficult to precisely define in the
control when treated with high-dose oral absence of a definitive set of tests for
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school cohort. Diabetes Care 2013;36:429–435 maternal disorders of glucose metabolism and lower cost in a large cohort of pregnant women:
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2008;31:899–904 80. Landon MB, Rice MM, Varner MW, et al.; Berger H. The impact of adoption of the
67. Poltavskiy E, Kim DJ, Bang H. Comparison of Eunice Kennedy Shriver National Institute of Child international association of diabetes in preg-
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Diabetes Care Volume 42, Supplement 1, January 2019 S29

3. Prevention or Delay of Type 2 American Diabetes Association

Diabetes: Standards of Medical


Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S29–S33 | https://doi.org/10.2337/dc19-S003

3. PREVENTION OR DELAY OF TYPE 2 DIABETES


The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”
includes ADA’s current clinical practice recommendations and is intended to
provide the components of diabetes care, general treatment goals and guidelines,
and tools to evaluate quality of care. Members of the ADA Professional Practice
Committee, a multidisciplinary expert committee, are responsible for updating
the Standards of Care annually, or more frequently as warranted. For a detailed
description of ADA standards, statements, and reports, as well as the evidence-
grading system for ADA’s clinical practice recommendations, please refer to the
Standards of Care Introduction. Readers who wish to comment on the Standards
of Care are invited to do so at professional.diabetes.org/SOC.

For guidelines related to screening for increased risk for type 2 diabetes (prediabetes),
please refer to Section 2 “Classification and Diagnosis of Diabetes.”
Recommendation
3.1 At least annual monitoring for the development of type 2 diabetes in those
with prediabetes is suggested. E

Screening for prediabetes and type 2 diabetes risk through an informal assessment
of risk factors (Table 2.3) or with an assessment tool, such as the American
Diabetes Association risk test (Fig. 2.1), is recommended to guide providers on
whether performing a diagnostic test for prediabetes (Table 2.5) and previ-
ously undiagnosed type 2 diabetes (Table 2.2) is appropriate (see Section
2 “Classification and Diagnosis of Diabetes”). Those determined to be at high
risk for type 2 diabetes, including people with A1C 5.726.4% (39247 mmol/mol),
impaired glucose tolerance, or impaired fasting glucose, are ideal candidates
for diabetes prevention efforts. Using A1C to screen for prediabetes may
be problematic in the presence of certain hemoglobinopathies or conditions
that affect red blood cell turnover. See Section 2 “Classification and Diagnosis of
Diabetes” and Section 6 “Glycemic Targets” for additional details on the appropriate
use of the A1C test.
At least annual monitoring for the development of diabetes in those with Suggested citation: American Diabetes Associa-
tion. 3. Prevention or delay of type 2 diabetes:
prediabetes is suggested.
Standards of Medical Care in Diabetesd2019.
Diabetes Care 2019;42(Suppl. 1):S29–S33
LIFESTYLE INTERVENTIONS © 2018 by the American Diabetes Association.
Readers may use this article as long as the work
Recommendations is properly cited, the use is educational and not
3.2 Refer patients with prediabetes to an intensive behavioral lifestyle interven- for profit, and the work is not altered. More infor-
tion program modeled on the Diabetes Prevention Program (DPP) to achieve mation is available at http://www.diabetesjournals
.org/content/license.
S30 Prevention or Delay of Type 2 Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

and maintain 7% loss of ini- specific methods used to achieve the Nutrition
tial body weight and increase goals (6). Structured behavioral weight loss ther-
moderate-intensity physical ac- The 7% weight loss goal was selected apy, including a reduced calorie meal
tivity (such as brisk walking) to because it was feasible to achieve and plan and physical activity, is of para-
at least 150 min/week. A maintain and likely to lessen the risk of mount importance for those at high
3.3 Based on patient preference, developing diabetes. Participants were risk for developing type 2 diabetes who
technology-assisted diabetes encouraged to achieve the 7% weight have overweight or obesity (1,7). Be-
prevention interventions may loss during the first 6 months of the cause weight loss through lifestyle
be effective in preventing type intervention. However, longer-term changes alone can be difficult to maintain
2 diabetes and should be con- (4-year) data reveal maximal prevention long term (4), people being treated with
sidered. B of diabetes observed at about 7–10% weight loss therapy should have access
3.4 Given the cost-effectiveness of weight loss (7). The recommended pace to ongoing support and additional thera-
diabetes prevention, such inter- of weight loss was 122 lb/week. Calorie peutic options (such as pharmacother-
vention programs should be cov- goals were calculated by estimating the apy) if needed. Based on intervention
ered by third-party payers. B daily calories needed to maintain the trials, the eating patterns that may be
participant’s initial weight and subtract- helpful for those with prediabetes
The Diabetes Prevention Program ing 50021,000 calories/day (depending include a Mediterranean eating plan
Several major randomized controlled tri- on initial body weight). The initial focus (8–11) and a low-calorie, low-fat eating
als, including the Diabetes Prevention was on reducing total dietary fat. After plan (5). Additional research is needed
Program (DPP) (1), the Finnish Diabetes several weeks, the concept of calorie regarding whether a low-carbohydrate
Prevention Study (DPS) (2), and the Da balance and the need to restrict calories eating plan is beneficial for persons with
Qing Diabetes Prevention Study (Da Qing as well as fat was introduced (6). prediabetes (12). In addition, evidence
study) (3), demonstrate that lifestyle/ The goal for physical activity was se- suggests that the overall quality of food
behavioral therapy featuring an indi- lected to approximate at least 700 kcal/ consumed (as measured by the Alterna-
vidualized reduced calorie meal plan is week expenditure from physical activity. tive Healthy Eating Index), with an em-
highly effective in preventing type 2 For ease of translation, this goal was phasis on whole grains, legumes, nuts,
diabetes and improving other cardiome- described as at least 150 min of moderate- fruits and vegetables, and minimal re-
tabolic markers (such as blood pressure, intensity physical activity per week fined and processed foods, is also im-
lipids, and inflammation). The strongest similar in intensity to brisk walking. Par- portant (13–15).
evidence for diabetes prevention comes ticipants were encouraged to distribute Whereas overall healthy low-calorie
from the DPP trial (1). The DPP demon- their activity throughout the week with eating patterns should be encouraged,
strated that an intensive lifestyle inter- a minimum frequency of three times per there is also some evidence that partic-
vention could reduce the incidence of week with at least 10 min per session. A ular dietary components impact diabetes
type 2 diabetes by 58% over 3 years. maximum of 75 min of strength training risk in observational studies. Higher in-
Follow-up of three large studies of life- could be applied toward the total takes of nuts (16), berries (17), yogurt
style intervention for diabetes preven- 150 min/week physical activity goal (6). (18,19), coffee, and tea (20) are associ-
tion has shown sustained reduction in To implement the weight loss and ated with reduced diabetes risk. Con-
the rate of conversion to type 2 diabetes: physical activity goals, the DPP used an in- versely, red meats and sugar-sweetened
45% reduction at 23 years in the Da Qing dividual model of treatment rather than beverages are associated with an in-
study (3), 43% reduction at 7 years in the a group-based approach. This choice was creased risk of type 2 diabetes (13).
DPS (2), and 34% reduction at 10 years (4) based on a desire to intervene before As is the case for those with diabetes,
and 27% reduction at 15 years (5) in the participants had the possibility of devel- individualized medical nutrition therapy
U.S. Diabetes Prevention Program Out- oping diabetes or losing interest in the (see Section 5 “Lifestyle Management”
comes Study (DPPOS). Notably, in the program. The individual approach also for more detailed information) is effec-
23-year follow-up for the Da Qing study, allowed for tailoring of interventions to tive in lowering A1C in individuals di-
reductions in all-cause mortality and reflect the diversity of the population (6). agnosed with prediabetes (21).
cardiovascular disease–related mor- The DPP intervention was adminis-
tality were observed for the lifestyle tered as a structured core curriculum Physical Activity
intervention groups compared with the followed by a more flexible maintenance Just as 150 min/week of moderate-
control group (3). program of individual sessions, group intensity physical activity, such as brisk
The two major goals of the DPP in- classes, motivational campaigns, and re- walking, showed beneficial effects in
tensive, behavioral, lifestyle intervention start opportunities. The 16-session core those with prediabetes (1), moderate-
were to achieve and maintain a minimum curriculum was completed within the intensity physical activity has been
of 7% weight loss and 150 min of physical first 24 weeks of the program and in- shown to improve insulin sensitivity
activity similar in intensity to brisk walk- cluded sections on lowering calories, in- and reduce abdominal fat in children
ing per week. The DPP lifestyle interven- creasing physical activity, self-monitoring, and young adults (22,23). On the basis
tion was a goal-based intervention: all maintaining healthy lifestyle behaviors, of these findings, providers are encour-
participants were given the same weight and psychological, social, and motivational aged to promote a DPP-style program,
loss and physical activity goals, but in- challenges. For further details on the core including its focus on physical activity, to
dividualization was permitted in the curriculum sessions, refer to ref. 6. all individuals who have been identified
care.diabetesjournals.org Prevention or Delay of Type 2 Diabetes S31

to be at an increased risk of type 2 are promising (39). In an effort to expand Administration specifically for diabetes
diabetes. In addition to aerobic activity, preventive services using a cost-effective prevention. One has to balance the risk/
an exercise regimen designed to prevent model that began in April 2018, the Centers benefit of each medication. Metformin
diabetes may include resistance training for Medicare & Medicaid Services has has the strongest evidence base (50) and
(6,24). Breaking up prolonged sedentary expanded Medicare reimbursement cov- demonstrated long-term safety as phar-
time may also be encouraged, as it is erage for the National DPP lifestyle inter- macologic therapy for diabetes preven-
associated with moderately lower post- vention to organizations recognized by the tion (48). For other drugs, cost, side
prandial glucose levels (25,26). The pre- CDC that become Medicare suppliers for effects, and durable efficacy require
ventive effects of exercise appear to this service (https://innovation.cms.gov/ consideration.
extend to the prevention of gestational initiatives/medicare-diabetes-prevention- Metformin was overall less effective
diabetes mellitus (GDM) (27). program/). than lifestyle modification in the DPP
and DPPOS, though group differences
Technology-Assisted Interventions to Tobacco Use declined over time (5) and metformin
Deliver Lifestyle Interventions Smoking may increase the risk of type 2 may be cost-saving over a 10-year period
Technology-assisted interventions may diabetes (40); therefore, evaluation for (34). It was as effective as lifestyle mod-
effectively deliver the DPP lifestyle tobacco use and referral for tobacco ification in participants with BMI $35
intervention, reducing weight and, cessation, if indicated, should be part kg/m2 but not significantly better than
therefore, diabetes risk (28–31). Such of routine care for those at risk for di- placebo in those over 60 years of age (1).
technology-assisted interventions may abetes. Of note, the years immediately In the DPP, for women with history of
deliver content through smartphone following smoking cessation may rep- GDM, metformin and intensive lifestyle
and web-based applications and tele- resent a time of increased risk for di- modification led to an equivalent 50%
health (28). The Centers for Disease abetes (40–42) and patients should be reduction in diabetes risk (51), and both
Control and Prevention (CDC) Diabetes monitored for diabetes development interventions remained highly effective
Prevention Recognition Program (DPRP) and receive evidence-based interven- during a 10-year follow-up period (52).
(www.cdc.gov/diabetes/prevention/ tions for diabetes prevention as de- In the Indian Diabetes Prevention Pro-
lifestyle-program) does certify technology- scribed in this section. See Section gramme (IDPP-1), metformin and the
assisted modalities as effective vehicles 5 “Lifestyle Management” for more de- lifestyle intervention reduced diabetes
for DPP-based interventions; such pro- tailed information. risk similarly at 30 months; of note, the
grams must use an approved curricu- lifestyle intervention in IDPP-1 was
lum, include interaction with a coach less intensive than that in the DPP (53).
(which may be virtual), and attain the PHARMACOLOGIC Based on findings from the DPP, met-
DPRP outcomes of participation, phys- INTERVENTIONS formin should be recommended as an
ical activity reporting, and weight loss. Recommendations
option for high-risk individuals (e.g.,
The selection of an in-person or virtual 3.5 Metformin therapy for preven- those with a history of GDM or those
program should be based on patient tion of type 2 diabetes should be with BMI $35 kg/m2). Consider monitor-
preference. considered in those with predia- ing vitamin B12 levels in those taking
betes, especially for those with metformin chronically to check for
Cost-effectiveness BMI $35 kg/m2, those aged possible deficiency (54) (see Section 9
A cost-effectiveness model suggested that ,60 years, and women with “Pharmacologic Approaches to Glycemic
the lifestyle intervention used in the DPP prior gestational diabetes melli- Treatment” for more details).
was cost-effective (32,33). Actual cost data tus. A
from the DPP and DPPOS confirmed this 3.6 Long-term use of metformin may
(34). Group delivery of DPP content in PREVENTION OF
be associated with biochemical CARDIOVASCULAR DISEASE
community or primary care settings has vitamin B12 deficiency, and pe-
the potential to reduce overall program riodic measurement of vitamin Recommendation
costs while still producing weight loss and B12 levels should be considered 3.7 Prediabetes is associated with
diabetes risk reduction (35–37). The use of in metformin-treated patients, heightened cardiovascular risk;
community health workers to support DPP especially in those with anemia therefore, screening for and treat-
efforts has been shown to be effective with or peripheral neuropathy. B ment of modifiable risk factors
cost savings (38) (see Section 1 “Improving for cardiovascular disease is sug-
Care and Promoting Health in Populations” gested. B
for more information). The CDC coordi- Pharmacologic agents including metfor-
nates the National Diabetes Prevention min, a-glucosidase inhibitors, glucagon- People with prediabetes often have other
Program (National DPP), a resource de- like peptide 1 receptor agonists, cardiovascular risk factors, including hy-
signed to bring evidence-based lifestyle thiazolidinediones, and several agents ap- pertension and dyslipidemia (55), and are
change programs for preventing type 2 proved for weight loss have been shown in at increased risk for cardiovascular dis-
diabetes to communities (www.cdc.gov/ research studies to decrease the incidence ease (56). Although treatment goals for
diabetes/prevention/index.htm). Early of diabetes to various degrees in those with people with prediabetes are the same as
results from the CDC’s National DPP prediabetes (1,43–49), though none are for the general population (57), in-
during the first 4 years of implementation approved by the U.S. Food and Drug creased vigilance is warranted to identify
S32 Prevention or Delay of Type 2 Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

and treat these and other cardiovascular and microvascular complications over 15-year 20. Mozaffarian D. Dietary and policy priorities
risk factors (e.g., smoking). follow-up: the Diabetes Prevention Program for cardiovascular disease, diabetes, and obesity:
Outcomes Study. Lancet Diabetes Endocrinol a comprehensive review. Circulation 2016;133:
2015;3:866–875 187–225
DIABETES SELF-MANAGEMENT 6. Diabetes Prevention Program (DPP) Research 21. Parker AR, Byham-Gray L, Denmark R,
Group. The Diabetes Prevention Program (DPP): Winkle PJ. The effect of medical nutrition therapy
EDUCATION AND SUPPORT
description of lifestyle intervention. Diabetes by a registered dietitian nutritionist in patients
Recommendation Care 2002;25:2165–2171 with prediabetes participating in a randomized
7. Hamman RF, Wing RR, Edelstein SL, et al. controlled clinical research trial. J Acad Nutr Diet
3.8 Diabetes self-management edu-
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be appropriate venues for people 2107 Exercise and insulin resistance in youth: a meta-
with prediabetes to receive edu- 8. Salas-Salvadó J, Bulló M, Babio N, et al.; analysis. Pediatrics 2014;133:e163–e174
cation and support to develop PREDIMED Study Investigators. Reduction in 23. Davis CL, Pollock NK, Waller JL, et al. Exercise
the incidence of type 2 diabetes with the Med- dose and diabetes risk in overweight and obese
and maintain behaviors that
iterranean diet: results of the PREDIMED-Reus children: a randomized controlled trial. JAMA
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Although reimbursement remains a bar- 12. Noto H, Goto A, Tsujimoto T, Noda M. Long- L, Whitcomb BW. Physical activity interventions
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17:60–70 28. Grock S, Ku J-H, Kim J, Moin T. A review of
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of diabetes (21,58). Lancet 2014;383:1999–2007 Diabetes Prevention Program into an online
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363 44. Torgerson JS, Hauptman J, Boldrin MN, The effect of lifestyle intervention and metformin
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S34 Diabetes Care Volume 42, Supplement 1, January 2019

4. Comprehensive Medical American Diabetes Association

Evaluation and Assessment of


Comorbidities: Standards of
Medical Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S34–S45 | https://doi.org/10.2337/dc19-S004
4. MEDICAL EVALUATION AND COMORBIDITIES

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”


includes ADA’s current clinical practice recommendations and is intended to
provide the components of diabetes care, general treatment goals and guidelines,
and tools to evaluate quality of care. Members of the ADA Professional Practice
Committee, a multidisciplinary expert committee, are responsible for updating the
Standards of Care annually, or more frequently as warranted. For a detailed
description of ADA standards, statements, and reports, as well as the evidence-
grading system for ADA’s clinical practice recommendations, please refer to the
Standards of Care Introduction. Readers who wish to comment on the Standards
of Care are invited to do so at professional.diabetes.org/SOC.

PATIENT-CENTERED COLLABORATIVE CARE


Recommendations
4.1 A patient-centered communication style that uses person-centered and
strength-based language and active listening, elicits patient preferences
and beliefs, and assesses literacy, numeracy, and potential barriers to care
should be used to optimize patient health outcomes and health-related
quality of life. B
4.2 Diabetes care should be managed by a multidisciplinary team that may draw
from primary care physicians, subspecialty physicians, nurse practitioners,
physician assistants, nurses, dietitians, exercise specialists, pharmacists,
dentists, podiatrists, and mental health professionals. E

A successful medical evaluation depends on beneficial interactions between the


patient and the care team. The Chronic Care Model (1–3) (see Section 1 “Improving
Care and Promoting Health in Populations”) is a patient-centered approach to
care that requires a close working relationship between the patient and clinicians
Suggested citation: American Diabetes Associa-
involved in treatment planning. People with diabetes should receive health care tion. 4. Comprehensive medical evaluation and
from an interdisciplinary team that may include physicians, nurse practitioners, assessment of comorbidities: Standards of
physician assistants, nurses, dietitians, exercise specialists, pharmacists, dentists, Medical Care in Diabetesd2019. Diabetes Care
podiatrists, and mental health professionals. Individuals with diabetes must assume 2019;42(Suppl. 1):S34–S45
an active role in their care. The patient, family or support people, physicians, and © 2018 by the American Diabetes Association.
health care team should together formulate the management plan, which includes Readers may use this article as long as the work
is properly cited, the use is educational and not
lifestyle management (see Section 5 “Lifestyle Management”). for profit, and the work is not altered. More infor-
The goals of treatment for diabetes are to prevent or delay complications mation is available at http://www.diabetesjournals
and maintain quality of life (Fig. 4.1). Treatment goals and plans should be created .org/content/license.
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S35

Figure 4.1—Decision cycle for patient-centered glycemic management in type 2 diabetes. Adapted from Davies et al. (119).

with the patients based on their individ- assess and address self-management assessment, patient education, and
ual preferences, values, and goals. The barriers without blaming patients for treatment planning.
management plan should take into “noncompliance” or “nonadherence” Language has a strong impact on per-
account the patient’s age, cognitive abil- when the outcomes of self-management ceptions and behavior. The use of em-
ities, school/work schedule and condi- are not optimal (8). The familiar terms powering language in diabetes care and
tions, health beliefs, support systems, “noncompliance” and “nonadherence” education can help to inform and motivate
eating patterns, physical activity, social denote a passive, obedient role for a people, yet language that shames and
situation, financial concerns, cultural fac- person with diabetes in “following doc- judges may undermine this effort. The
tors, literacy and numeracy (mathemat- tor’s orders” that is at odds with the American Diabetes Association (ADA) and
ical literacy), diabetes complications active role people with diabetes take in American Association of Diabetes Educa-
and duration of disease, comorbidities, directing the day-to-day decision mak- tors consensus report, “The Use of Lan-
health priorities, other medical condi- ing, planning, monitoring, evaluation, guage in Diabetes Care and Education,”
tions, preferences for care, and life and problem-solving involved in diabetes provides the authors’ expert opinion re-
expectancy. Various strategies and tech- self-management. Using a nonjudg- garding the use of language by health care
niques should be used to support mental approach that normalizes peri- professionals when speaking or writing
patients’ self-management efforts, in- odic lapses in self-management may help about diabetes for people with diabetes or
cluding providing education on problem- minimize patients’ resistance to report- for professional audiences (14). Although
solving skills for all aspects of diabetes ing problems with self-management. further research is needed to address the
management. Empathizing and using active listening impact of language on diabetes outcomes,
Provider communications with patients techniques, such as open-ended ques- the report includes five key consensus
and families should acknowledge that tions, reflective statements, and summa- recommendations for language use:
multiple factors impact glycemic manage- rizing what the patient said, can help
ment but also emphasize that collab- facilitate communication. Patients’ per- ○ Use language that is neutral, nonjudg-
oratively developed treatment plans ceptions about their own ability, or self- mental, and based on facts, actions, or
and a healthy lifestyle can significantly efficacy, to self-manage diabetes are one physiology/biology.
improve disease outcomes and well- important psychosocial factor related to ○ Use language that is free from stigma.
being (4–7). Thus, the goal of provider- improved diabetes self-management ○ Use language that is strength based,
patient communication is to establish and treatment outcomes in diabetes (9– respectful, and inclusive and that im-
a collaborative relationship and to 13) and should be a target of ongoing parts hope.
S36 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 42, Supplement 1, January 2019

○ Use language that fosters collabora- of the patient throughout the process. for complications and comorbidities. Dis-
tion between patients and providers. While a comprehensive list is provided cussing and implementing an approach
○ Use language that is person centered in Table 4.1, in clinical practice, the to glycemic control with the patient is a
(e.g., “person with diabetes” is pre- provider may need to prioritize the com- part, not the sole goal, of the patient
ferred over “diabetic”). ponents of the medical evaluation given encounter.
the available resources and time. The
goal is to provide the health care team
COMPREHENSIVE MEDICAL Immunizations
information to optimally support a pa-
EVALUATION
tient. In addition to the medical history, Recommendations
Recommendations physical examination, and laboratory 4.7 Provide routinely recommended
4.3 A complete medical evaluation tests, providers should assess diabetes vaccinations for children and
should be performed at the ini- self-management behaviors, nutrition, adults with diabetes by age. C
tial visit to: and psychosocial health (see Section 5 4.8 Annual vaccination against in-
○ Confirm the diagnosis and classify “Lifestyle Management”) and give guid- fluenza is recommended for all
diabetes. B ance on routine immunizations. The people $6 months of age, es-
○ Evaluate for diabetes complica- assessment of sleep pattern and dura- pecially those with diabetes. C
tions and potential comorbid tion should be considered; a recent meta- 4.9 Vaccination against pneumo-
conditions. B analysis found that poor sleep quality, coccal disease, including pneu-
○ Review previous treatment and short sleep, and long sleep were associ- mococcal pneumonia, with
risk factor control in patients ated with higher A1C in people with 13-valent pneumococcal conju-
with established diabetes. B type 2 diabetes (15). Interval follow-up gate vaccine (PCV13) is recom-
○ Begin patient engagement in the visits should occur at least every 3–6 mended for children before age
formulation of a care manage- months, individualized to the patient, 2 years. People with diabetes
ment plan. B and then annually. ages 2 through 64 years should
○ Develop a plan for continuing Lifestyle management and psychoso- also receive 23-valent pneu-
care. B cial care are the cornerstones of diabe- mococcal polysaccharide vaccine
4.4 A follow-up visit should include tes management. Patients should be (PPSV23). At age $65 years,
most components of the initial referred for diabetes self-management regardless of vaccination his-
comprehensive medical evalua- education and support, medical nutri- tory, additional PPSV23 vacci-
tion including: interval medical tion therapy, and assessment of psy- nation is necessary. C
history, assessment of medication- chosocial/emotional health concerns if 4.10 Administer a 2- or 3-dose series
taking behavior and intolerance/ indicated. Patients should receive rec- of hepatitis B vaccine, depend-
side effects, physical examina- ommended preventive care services ing on the vaccine, to unvacci-
tion, laboratory evaluation as ap- (e.g., immunizations, cancer screening, nated adults with diabetes ages
propriate to assess attainment etc.), smoking cessation counseling, and 18 through 59 years. C
of A1C and metabolic targets, ophthalmological, dental, and podiatric 4.11 Consider administering 3-dose
and assessment of risk for compli- referrals. series of hepatitis B vaccine to
cations, diabetes self-management The assessment of risk of acute and unvaccinated adults with dia-
behaviors, nutrition, psychosocial chronic diabetes complications and treat- betes ages $60 years. C
health, and the need for referrals, ment planning are key components of
immunizations, or other routine initial and follow-up visits (Table 4.2). Children and adults with diabetes
health maintenance screening. B The risk of atherosclerotic cardiovascu- should receive vaccinations according
4.5 Ongoing management should be lar disease and heart failure (Section to age-appropriate recommendations
guided by the assessment of di- 10 “Cardiovascular Disease and Risk (16,17). The child and adolescent (#18
abetes complications and shared Management”), chronic kidney disease years of age) vaccination schedule is
decision making to set therapeu- staging (Section 11 “Microvascular available at www.cdc.gov/vaccines/
tic goals. B Complications and Foot Care”), and schedules/hcp/imz/child-adolescent.html,
4.6 The 10-year risk of a first athero- risk of treatment-associated hypogly- and the adult ($19 years of age) vacci-
sclerotic cardiovascular disease cemia (Table 4.3) should be used to nation schedule is available at www.cdc
event should be assessed using individualize targets for glycemia (Sec- .gov/vaccines/schedules/hcp/imz/adult
the race- and sex-specific Pooled tion 6 “Glycemic Targets”), blood pres- .html. These immunization schedules in-
Cohort Equations to better strat- sure, and lipids and to select specific clude vaccination schedules specifically
ify atherosclerotic cardiovascular glucose-lowering medication (Section 9 for children, adolescents, and adults with
disease risk. B “Pharmacologic Approaches to Glycemic diabetes.
Treatment”), antihypertension medica- People with diabetes are at higher
The comprehensive medical evaluation tion, or statin treatment intensity. risk for hepatitis B infection and are
includes the initial and follow-up evalua- Additional referrals should be ar- more likely to develop complications
tions, assessment of complications, psy- ranged as necessary (Table 4.4). Clini- from influenza and pneumococcal dis-
chosocial assessment, management of cians should ensure that individuals ease. The Centers for Disease Control and
comorbid conditions, and engagement with diabetes are appropriately screened Prevention (CDC) Advisory Committee
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S37

Continued on p. S38
S38 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 42, Supplement 1, January 2019

on Immunization Practices (ACIP) recom- the elderly and people with chronic dis- recommendations from the CDC ACIP
mends influenza, pneumococcal, and eases. Influenza vaccination in people that adults age $65 years, who are at
hepatitis B vaccinations specifically for with diabetes has been found to signif- higher risk for pneumococcal disease,
people with diabetes. Vaccinations icantly reduce influenza and diabetes- receive an additional 23-valent pneumo-
against tetanus-diphtheria-pertussis, related hospital admissions (18). coccal polysaccharide vaccine (PPSV23),
measles-mumps-rubella, human papillo- regardless of prior pneumococcal vacci-
mavirus, and shingles are also important Pneumococcal Pneumonia nation history. See detailed recommen-
for adults with diabetes, as they are for Like influenza, pneumococcal pneumo- dations at www.cdc.gov/vaccines/hcp/
the general population. nia is a common, preventable disease. acip-recs/vacc-specific/pneumo.html.
People with diabetes are at increased
Influenza risk for the bacteremic form of pneu- Hepatitis B
Influenza is a common, preventable in- mococcal infection and have been re- Compared with the general population,
fectious disease associated with high ported to have a high risk of nosocomial people with type 1 or type 2 diabetes
mortality and morbidity in vulnerable bacteremia, with a mortality rate as have higher rates of hepatitis B. This may
populations including the young and high as 50% (19). The ADA endorses be due to contact with infected blood
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S39

Table 4.2—Assessment and treatment plan* disease) (see Section 13 “Children and
Assess risk of diabetes complications Adolescents”).
c ASCVD and heart failure history
c ASCVD risk factors (see Table 10.2) and 10-year ASCVD risk assessment
Cancer
c Staging of chronic kidney disease (see Table 11.1)
Diabetes is associated with increased
c Hypoglycemia risk (Table 4.3)
Goal setting
risk of cancers of the liver, pancreas,
c Set A1C/blood glucose target
endometrium, colon/rectum, breast,
c If hypertension present, establish blood pressure target
and bladder (29). The association may
c Diabetes self-management goals (e.g., monitoring frequency)
result from shared risk factors between
Therapeutic treatment plan type 2 diabetes and cancer (older age,
c Lifestyle management obesity, and physical inactivity) but may
c Pharmacologic therapy (glucose lowering) also be due to diabetes-related factors
c Pharmacologic therapy (cardiovascular disease risk factors and renal) (30), such as underlying disease physiol-
c Use of glucose monitoring and insulin delivery devices ogy or diabetes treatments, although
c Referral to diabetes education and medical specialists (as needed) evidence for these links is scarce. Patients
ASCVD, atherosclerotic cardiovascular disease. *Assessment and treatment planning is an with diabetes should be encouraged to
essential component of initial and all follow-up visits. undergo recommended age- and sex-
appropriate cancer screenings and to
reduce their modifiable cancer risk fac-
or through improper equipment use Autoimmune Diseases
tors (obesity, physical inactivity, and
(glucose monitoring devices or infected
Recommendation smoking). New onset of atypical diabetes
needles). Because of the higher likeli-
4.12 Consider screening patients (lean body habitus, negative family his-
hood of transmission, hepatitis B vac-
with type 1 diabetes for auto- tory) in a middle-aged or older patient
cine is recommended for adults with
immune thyroid disease and may precede the diagnosis of pancre-
diabetes age ,60 years. For adults age
celiac disease soon after diag- atic adenocarcinoma (31). However, in
$60 years, hepatitis B vaccine may be
nosis. B the absence of other symptoms (e.g.,
administered at the discretion of the
weight loss, abdominal pain), routine
treating clinician based on the patient’s People with type 1 diabetes are at in- screening of all such patients is not
likelihood of acquiring hepatitis B creased risk for other autoimmune currently recommended.
infection. diseases including thyroid disease, pri-
mary adrenal insufficiency, celiac disease, Cognitive Impairment/Dementia
ASSESSMENT OF COMORBIDITIES autoimmune gastritis, autoimmune hep-
Recommendation
Besides assessing diabetes-related com- atitis, dermatomyositis, and myasthenia
4.13 In people with a history of cog-
plications, clinicians and their patients gravis (25–27). Type 1 diabetes may also
nitive impairment/dementia, in-
need to be aware of common comorbid- occur with other autoimmune diseases
tensive glucose control cannot
ities that affect people with diabetes in the context of specific genetic dis-
be expected to remediate def-
and may complicate management orders or polyglandular autoimmune syn-
icits. Treatment should be
(20–24). Diabetes comorbidities are con- dromes (28). In autoimmune diseases,
tailored to avoid significant
ditions that affect people with diabetes the immune system fails to maintain
hypoglycemia. B
more often than age-matched people self-tolerance to specific peptides within
without diabetes. This section includes target organs. It is likely that many factors
Diabetes is associated with a significantly
many of the common comorbidities ob- trigger autoimmune disease; however,
increased risk and rate of cognitive de-
served in patients with diabetes but is not common triggering factors are known
cline and an increased risk of demen-
necessarily inclusive of all the conditions for only some autoimmune condi-
tia (32,33). A recent meta-analysis of
that have been reported. tions (i.e., gliadin peptides in celiac
prospective observational studies in peo-
ple with diabetes showed 73% in-
Table 4.3—Assessment of hypoglycemia risk creased risk of all types of dementia,
Factors that increase risk of treatment-associated hypoglycemia 56% increased risk of Alzheimer de-
c Use of insulin or insulin secretagogues (i.e., sulfonylureas, meglitinides)
mentia, and 127% increased risk of
c Impaired kidney or hepatic function
vascular dementia compared with in-
c Longer duration of diabetes
dividuals without diabetes (34). The
c Frailty and older age
reverse is also true: people with Alz-
c Cognitive impairment
heimer dementia are more likely to
c Impaired counterregulatory response, hypoglycemia unawareness
c Physical or intellectual disability that may impair behavioral response to hypoglycemia
develop diabetes than people without
c Alcohol use
Alzheimer dementia. In a 15-year pro-
c Polypharmacy (especially ACE inhibitors, angiotensin receptor blockers, nonselective
spective study of community-dwelling
b-blockers) people .60 years of age, the presence
of diabetes at baseline significantly
See references 114–118.
increased the age- and sex-adjusted
S40 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 42, Supplement 1, January 2019

Table 4.4—Referrals for initial care evidence to recommend any dietary has also shown some promise in pre-
management change for the prevention or treatment liminary studies, although benefits may
c Eye care professional for annual dilated of cognitive dysfunction (41). be mediated, at least in part, by weight
eye exam loss (48–50).
Statins
c Family planning for women of
reproductive age A systematic review has reported that
data do not support an adverse effect Pancreatitis
c Registered dietitian for medical nutrition
therapy of statins on cognition (42). The U.S. Food Recommendation
c Diabetes self-management education and Drug Administration postmarket- 4.15 Islet autotransplantation should
and support ing surveillance databases have also be considered for patients re-
c Dentist for comprehensive dental and revealed a low reporting rate for cog- quiring total pancreatectomy
periodontal examination nitive-related adverse events, including for medically refractory chronic
c Mental health professional, if indicated
cognitive dysfunction or dementia, with pancreatitis to prevent postsur-
statin therapy, similar to rates seen with gical diabetes. C
other commonly prescribed cardiovas-
incidence of all-cause dementia, Alz- cular medications (42). Therefore, fear Diabetes is linked to diseases of the
heimer dementia, and vascular demen- of cognitive decline should not be a bar- exocrine pancreas such as pancreatitis,
tia compared with rates in those with rier to statin use in individuals with di- which may disrupt the global architecture
normal glucose tolerance (35). abetes and a high risk for cardiovascular or physiology of the pancreas, often re-
disease. sulting in both exocrine and endocrine
Hyperglycemia
dysfunction. Up to half of patients with
In those with type 2 diabetes, the degree Nonalcoholic Fatty Liver Disease diabetes may have impaired exocrine pan-
and duration of hyperglycemia are related creas function (51). People with diabetes
todementia.Morerapidcognitivedeclineis Recommendation
are at an approximately twofold higher risk
associated with both increased A1C and 4.14 Patients with type 2 diabetes or
of developing acute pancreatitis (52).
longerdurationofdiabetes(34).TheAction prediabetes and elevated liver
Conversely, prediabetes and/or dia-
to Control Cardiovascular Risk in Diabetes enzymes (alanine aminotrans-
betes has been found to develop in ap-
(ACCORD) study found that each 1% higher ferase) or fatty liver on ultra-
proximately one-third of patients after
A1C level was associated with lower cog- sound should be evaluated for
an episode of acute pancreatitis (53),
nitive function in individuals with type 2 presence of nonalcoholic steato-
thus the relationship is likely bidirec-
diabetes (36). However, the ACCORD hepatitis and liver fibrosis. C
tional. Postpancreatitis diabetes may
study found no difference in cognitive include either new-onset disease or previ-
outcomes in participants randomly Diabetes is associated with the develop-
ously unrecognized diabetes (54). Studies
assigned to intensive and standard ment of nonalcoholic fatty liver disease,
of patients treated with incretin-based
glycemic control, supporting the recom- including its more severe manifesta-
therapies for diabetes have also reported
mendation that intensive glucose con- tions of nonalcoholic steatohepatitis,
that pancreatitis may occur more fre-
trol should not be advised for the liver fibrosis, cirrhosis, and hepatocel-
quently with these medications, but re-
improvement of cognitive function in lular carcinoma (43). Elevations of he-
sults have been mixed (55,56).
individuals with type 2 diabetes (37). patic transaminase concentrations are
Islet autotransplantation should be
associated with higher BMI, waist cir-
Hypoglycemia considered for patients requiring total
cumference, and triglyceride levels and
In type 2 diabetes, severe hypoglycemia pancreatectomy for medically refractory
lower HDL cholesterol levels. Noninva-
is associated with reduced cognitive chronic pancreatitis to prevent postsur-
sive tests, such as elastography or fi-
function, and those with poor cognitive gical diabetes. Approximately one-third
brosis biomarkers, may be used to
function have more severe hypoglyce- of patients undergoing total pancreatec-
assess risk of fibrosis, but referral to
mia. In a long-term study of older pa- tomy with islet autotransplantation are
a liver specialist and liver biopsy may
tients with type 2 diabetes, individuals insulin free 1 year postoperatively, and
be required for definitive diagnosis
with one or more recorded episode of observational studies from different
(43a). Interventions that improve met-
severe hypoglycemia had a stepwise in- centers have demonstrated islet graft
abolic abnormalities in patients with
crease in risk of dementia (38). Likewise, function up to a decade after the surgery
diabetes (weight loss, glycemic control,
the ACCORD trial found that as cog- in some patients (57–61). Both patient
and treatment with specific drugs for
nitive function decreased, the risk of and disease factors should be carefully
hyperglycemia or dyslipidemia) are also
severe hypoglycemia increased (39). considered when deciding the indica-
beneficial for fatty liver disease (44,45).
Tailoring glycemic therapy may help to tions and timing of this surgery. Surger-
Pioglitazone and vitamin E treatment of
prevent hypoglycemia in individuals with ies should be performed in skilled
biopsy-proven nonalcoholic steatohe-
cognitive dysfunction. facilities that have demonstrated exper-
patitis have been shown to improve
tise in islet autotransplantation.
Nutrition liver histology, but effects on longer-
In one study, adherence to the Mediter- term clinical outcomes are not known
ranean diet correlated with improved (46,47). Treatment with liraglutide and Fractures
cognitive function (40). However, a re- with sodium–glucose cotransporter 2 in- Age-specific hip fracture risk is signifi-
cent Cochrane review found insufficient hibitors (dapagliflozin and empagliflozin) cantly increased in people with both
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S41

type 1 (relative risk 6.3) and type 2 reverse transcriptase inhibitors (NRTIs). men with diabetes who have symptoms
(relative risk 1.7) diabetes in both sexes New-onset diabetes is estimated to oc- or signs of low testosterone (hypogonad-
(62). Type 1 diabetes is associated with cur in more than 5% of patients infected ism), a morning total testosterone should
osteoporosis, but in type 2 diabetes, an with HIV on PIs, whereas more than 15% be measured using an accurate and reli-
increased risk of hip fracture is seen may have prediabetes (68). PIs are asso- able assay. Free or bioavailable testos-
despite higher bone mineral density ciated with insulin resistance and may also terone levels should also be measured in
(BMD) (63). In three large observational lead to apoptosis of pancreatic b-cells. men with diabetes who have total tes-
studies of older adults, femoral neck NRTIs also affect fat distribution (both tosterone levels close to the lower limit,
BMD T score and the World Health lipohypertrophy and lipoatrophy), which given expected decreases in sex hormone–
Organization Fracture Risk Assessment is associated with insulin resistance. binding globulin with diabetes. Further
Tool (FRAX) score were associated with Individuals with HIV are at higher risk testing (such as luteinizing hormone and
hip and nonspine fractures. Fracture for developing prediabetes and diabe- follicle-stimulating hormone levels) may be
risk was higher in participants with di- tes on antiretroviral (ARV) therapies, so needed to distinguish between primary
abetes compared with those without a screening protocol is recommended and secondary hypogonadism.
diabetes for a given T score and age (69). The A1C test may underestimate
or for a given FRAX score (64). Providers glycemia in people with HIV and is not
should assess fracture history and risk recommended for diagnosis and may Obstructive Sleep Apnea
factors in older patients with diabetes present challenges for monitoring (70). Age-adjusted rates of obstructive sleep
and recommend measurement of BMD if In those with prediabetes, weight loss apnea, a risk factor for cardiovascular
appropriate for the patient’s age and sex. through healthy nutrition and physical disease, are significantly higher (4- to
Fracture prevention strategies for people activity may reduce the progression 10-fold) with obesity, especially with
with diabetes are the same as for the toward diabetes. Among patients with central obesity (75). The prevalence of
general population and include vitamin HIV and diabetes, preventive health care obstructive sleep apnea in the popula-
D supplementation. For patients with using an approach similar to that used in tion with type 2 diabetes may be as high
type 2 diabetes with fracture risk fac- patients without HIV is critical to reduce as 23%, and the prevalence of any sleep-
tors, thiazolidinediones (65) and sodium– the risks of microvascular and macro- disordered breathing may be as high as
glucose cotransporter 2 inhibitors (66) vascular complications. 58% (76,77). In obese participants en-
should be used with caution. For patients with HIV and ARV- rolled in the Action for Health in Diabetes
associated hyperglycemia, it may be ap- (Look AHEAD) trial, it exceeded 80% (78).
Hearing Impairment propriate to consider discontinuing the Patients with symptoms suggestive of
Hearing impairment, both in high fre- problematic ARV agents if safe and ef- obstructive sleep apnea (e.g., excessive
quency and low/midfrequency ranges, is fective alternatives are available (71). daytime sleepiness, snoring, witnessed
more common in people with diabetes Before making ARV substitutions, care- apnea) should be considered for screen-
than in those without, perhaps due to fully consider the possible effect on HIV ing (79). Sleep apnea treatment (lifestyle
neuropathy and/or vascular disease. In a virological control and the potential ad- modification, continuous positive airway
National Health and Nutrition Examina- verse effects of new ARV agents. In some pressure, oral appliances, and surgery)
tion Survey (NHANES) analysis, hearing cases, antihyperglycemia agents may significantly improves quality of life and
impairment was about twice as prevalent still be necessary. blood pressure control. The evidence
in people with diabetes compared with for a treatment effect on glycemic con-
those without, after adjusting for age trol is mixed (80).
Low Testosterone in Men
and other risk factors for hearing impair-
ment (67). Recommendation Periodontal Disease
4.17 In men with diabetes who have Periodontal disease is more severe, and
symptoms or signs of hypogo- may be more prevalent, in patients with
HIV diabetes than in those without (81,82).
nadism, such as decreased sex-
Recommendation ual desire (libido) or activity, or Current evidence suggests that perio-
4.16 Patients with HIV should be erectile dysfunction, consider dontal disease adversely affects diabetes
screened for diabetes and pre- screening with a morning serum outcomes, although evidence for treat-
diabetes with a fasting glucose testosterone level. B ment benefits remains controversial (24).
test before starting antiretrovi-
ral therapy, at the time of switch- Mean levels of testosterone are lower in Psychosocial/Emotional Disorders
ing antiretroviral therapy, and men with diabetes compared with age- Prevalence of clinically significant psy-
3–6 months after starting or matched men without diabetes, but chopathology diagnoses are considerably
switching antiretroviral therapy. obesity is a major confounder (72,73). more common in people with diabetes
If initial screening results are Treatment in asymptomatic men is con- than in those without the disease (83).
normal, checking fasting glucose troversial. Testosterone replacement in Symptoms, both clinical and subclinical,
every year is advised. E men with symptomatic hypogonadism that interfere with the person’s ability to
may have benefits including improved carry out daily diabetes self-management
Diabetes risk is increased with certain sexual function, well-being, muscle mass tasks must be addressed. Providers should
protease inhibitors (PIs) and nucleoside and strength, and bone density (74). In consider an assessment of symptoms of
S42 Comprehensive Medical Evaluation and Assessment of Comorbidities Diabetes Care Volume 42, Supplement 1, January 2019

depression, anxiety, and disordered eat- occur (90). People with diabetes who ex- and family history of type 2 diabetes
ing and of cognitive capacities using hibit excessive diabetes self-management (96–98). Elevated depressive symptoms
patient-appropriate standardized/validated behaviors well beyond what is prescribed and depressive disorders affect one in
tools at the initial visit, at periodic in- or needed to achieve glycemic targets may four patients with type 1 or type 2 di-
tervals, and when there is a change in be experiencing symptoms of obsessive- abetes (99). Thus, routine screening for
disease, treatment, or life circumstance. compulsive disorder (91). depressive symptoms is indicated in this
Including caregivers and family members General anxiety is a predictor of high-risk population including people
in this assessment is recommended. injection-related anxiety and associated with type 1 or type 2 diabetes, gesta-
Diabetes distress is addressed in Section with fear of hypoglycemia (88,92). Fear tional diabetes mellitus, and postpartum
5 “Lifestyle Management,” as this state is of hypoglycemia and hypoglycemia un- diabetes. Regardless of diabetes type,
very common and distinct from the psy- awareness often co-occur, and interven- women have significantly higher rates
chological disorders discussed below tions aimed at treating one often benefit of depression than men (100).
(84). both (93). Fear of hypoglycemia may Routine monitoring with patient-
explain avoidance of behaviors associ- appropriate validated measures can help
ated with lowering glucose such as in- to identify if referral is warranted. Adult
Anxiety Disorders
creasing insulin doses or frequency of patients with a history of depressive
Recommendations monitoring. If fear of hypoglycemia is symptoms or disorder need ongoing
4.18 Consider screening for anxiety identified and a person does not have monitoring of depression recurrence
in people exhibiting anxiety symptoms of hypoglycemia, a structured within the context of routine care (96).
or worries regarding diabetes program of blood glucose awareness Integrating mental and physical health
complications, insulin injections training delivered in routine clinical care can improve outcomes. When a
or infusion, taking medications, practice can improve A1C, reduce the patient is in psychological therapy (talk
and/or hypoglycemia that in- rate of severe hypoglycemia, and restore therapy), the mental health provider
terfere with self-management hypoglycemia awareness (94,95). should be incorporated into the diabe-
behaviors and those who ex- tes treatment team (101).
press fear, dread, or irrational
Depression
thoughts and/or show anxiety
Disordered Eating Behavior
symptoms such as avoidance Recommendations
behaviors, excessive repetitive 4.20 Providers should consider an- Recommendations
behaviors, or social withdrawal. nual screening of all patients 4.23 Providers should consider
Refer for treatment if anxiety with diabetes, especially those reevaluating the treatment reg-
is present. B with a self-reported history of imen of people with diabetes
4.19 People with hypoglycemia un- depression, for depressive symp- who present with symptoms of
awareness, which can co-occur toms with age-appropriate de- disordered eating behavior, an
with fear of hypoglycemia, should pression screening measures, eating disorder, or disrupted
be treated using blood glucose recognizing that further evalu- patterns of eating. B
awareness training (or other ation will be necessary for in- 4.24 Consider screening for disor-
evidence-based intervention) dividuals who have a positive dered or disrupted eating using
to help reestablish awareness screen. B validated screening measures
of hypoglycemia and reduce 4.21 Beginning at diagnosis of com- when hyperglycemia and weight
fear of hypoglycemia. A plications or when there are loss are unexplained based on
significant changes in medical self-reported behaviors related
Anxiety symptoms and diagnosable status, consider assessment for to medication dosing, meal
disorders (e.g., generalized anxiety depression. B plan, and physical activity. In
disorder, body dysmorphic disorder, 4.22 Referrals for treatment of de- addition, a review of the med-
obsessive-compulsive disorder, spe- pression should be made to ical regimen is recommended
cific phobias, and posttraumatic stress mental health providers with to identify potential treatment-
disorder) are common in people with experience using cognitive be- related effects on hunger/
diabetes (85). havioral therapy, interpersonal caloric intake. B
The Behavioral Risk Factor Surveil- therapy, or other evidence-
lance System (BRFSS) estimated the life- based treatment approaches Estimated prevalence of disordered eat-
time prevalence of generalized anxiety in conjunction with collaborative ing behaviors and diagnosable eating
disorder to be 19.5% in people with care with the patient’s diabetes disorders in people with diabetes varies
either type 1 or type 2 diabetes (86). treatment team. A (102–104). For people with type 1 di-
Common diabetes-specific concerns in- abetes, insulin omission causing glycos-
clude fears related to hypoglycemia (87, History of depression, current depres- uria in order to lose weight is the most
88), not meeting blood glucose targets sion, and antidepressant medication use commonly reported disordered eating
(85), and insulin injections or infusion are risk factors for the development of behavior (105,106); in people with
(89). Onset of complications presents type 2 diabetes, especially if the individ- type 2 diabetes, bingeing (excessive food
another critical point when anxiety can ual has other risk factors such as obesity intake with an accompanying sense of
care.diabetesjournals.org Comprehensive Medical Evaluation and Assessment of Comorbidities S43

loss of control) is most commonly re- olanzapine, require greater monitoring 14. Dickinson JK, Guzman SJ, Maryniuk MD, et al.
ported. For people with type 2 diabe- because of an increase in risk of type 2 The use of language in diabetes care and
education. Diabetes Care 2017;40:1790–1799
tes treated with insulin, intentional diabetes associated with this medica- 15. Lee SWH, Ng KY, Chin WK. The impact of
omission is also frequently reported tion (113). sleep amount and sleep quality on glycemic
(107). People with diabetes and diagnos- control in type 2 diabetes: a systematic review
able eating disorders have high rates of References and meta-analysis. Sleep Med Rev 2017:31:91–
comorbid psychiatric disorders (108). 101
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S46 Diabetes Care Volume 42, Supplement 1, January 2019

5. Lifestyle Management: American Diabetes Association

Standards of Medical Care in


Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S46–S60 | https://doi.org/10.2337/dc19-S005

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”


includes ADA’s current clinical practice recommendations and is intended to pro-
vide the components of diabetes care, general treatment goals and guidelines,
5. LIFESTYLE MANAGEMENT

and tools to evaluate quality of care. Members of the ADA Professional Practice
Committee, a multidisciplinary expert committee, are responsible for updating
the Standards of Care annually, or more frequently as warranted. For a detailed
description of ADA standards, statements, and reports, as well as the evidence-
grading system for ADA’s clinical practice recommendations, please refer to the
Standards of Care Introduction. Readers who wish to comment on the Standards
of Care are invited to do so at professional.diabetes.org/SOC.

Lifestyle management is a fundamental aspect of diabetes care and includes diabetes


self-management education and support (DSMES), medical nutrition therapy (MNT),
physical activity, smoking cessation counseling, and psychosocial care. Patients and
care providers should focus together on how to optimize lifestyle from the time of
the initial comprehensive medical evaluation, throughout all subsequent evaluations
and follow-up, and during the assessment of complications and management of co-
morbid conditions in order to enhance diabetes care.

DIABETES SELF-MANAGEMENT EDUCATION AND SUPPORT


Recommendations
5.1 In accordance with the national standards for diabetes self-management
education and support, all people with diabetes should participate in diabetes
self-management education to facilitate the knowledge, skills, and ability
necessary for diabetes self-care. Diabetes self-management support is ad-
ditionally recommended to assist with implementing and sustaining skills
and behaviors needed for ongoing self-management. B
5.2 There are four critical times to evaluate the need for diabetes self-
management education and support: at diagnosis, annually, when compli-
cating factors arise, and when transitions in care occur. E
5.3 Clinical outcomes, health status, and quality of life are key goals of diabetes
self-management education and support that should be measured as part of Suggested citation: American Diabetes Associa-
tion. 5. Lifestyle management: Standards of
routine care. C
Medical Care in Diabetesd2019. Diabetes Care
5.4 Diabetes self-management education and support should be patient cen- 2019;42(Suppl. 1):S46–S60
tered, may be given in group or individual settings or using technology, and © 2018 by the American Diabetes Association.
should be communicated with the entire diabetes care team. A Readers may use this article as long as the work is
5.5 Because diabetes self-management education and support can improve properly cited, the use is educational and not
outcomes and reduce costs B, adequate reimbursement by third-party payers for profit, and the work is not altered. More infor-
is recommended. E mation is available at http://www.diabetesjournals
.org/content/license.
care.diabetesjournals.org Lifestyle Management S47

DSMES services facilitate the knowledge, 3. When new complicating factors diabetes management (BC-ADM) certifi-
skills, and abilities necessary for optimal (health conditions, physical limita- cation demonstrates specialized training
diabetes self-care and incorporate the tions, emotional factors, or basic and mastery of a specific body of knowl-
needs, goals, and life experiences of the living needs) arise that influence edge (4). Additionally, there is growing
person with diabetes. The overall objec- self-management evidence for the role of community
tives of DSMES are to support informed 4. When transitions in care occur health workers (36,37), as well as peer
decision making, self-care behaviors, (36–40) and lay leaders (41), in providing
problem-solving, and active collabora- DSMES focuses on supporting patient ongoing support.
tion with the health care team to improve empowerment by providing people with DSMES is associated with an increased
clinical outcomes, health status, and diabetes the tools to make informed self- use of primary care and preventive ser-
quality of life in a cost-effective manner management decisions (6). Diabetes care vices (18,42,43) and less frequent use of
(1). Providers are encouraged to consider has shifted to an approach that places acute care and inpatient hospital services
the burden of treatment and the pa- the person with diabetes and his or her (12). Patients who participate in DSMES
tient’s level of confidence/self-efficacy family at the center of the care model, are more likely to follow best practice
for management behaviors as well as the working in collaboration with health care treatment recommendations, particu-
level of social and family support when professionals. Patient-centered care is re- larly among the Medicare population,
providing DSMES. Patient performance spectful of and responsive to individual and have lower Medicare and insurance
of self-management behaviors, including patient preferences, needs, and values. claim costs (19,42). Despite these bene-
its effect on clinical outcomes, health It ensures that patient values guide all fits, reports indicate that only 5–7% of
status, and quality of life, as well as the decision making (7). individuals eligible for DSMES through
psychosocial factors impacting the per- Medicare or a private insurance plan
son’s self-management should be mon- Evidence for the Benefits actually receive it (44,45). This low par-
itored as part of routine clinical care. Studies have found that DSMES is asso- ticipation may be due to lack of referral or
In addition, in response to the growing ciated with improved diabetes knowl- other identified barriers such as logistical
literature that associates potentially judg- edge and self-care behaviors (8), lower issues (timing, costs) and the lack of a
mental words with increased feelings of A1C (7,9–11), lower self-reported weight perceived benefit (46). Thus, in addition
shame and guilt, providers are encouraged (12,13), improved quality of life (10,14), to educating referring providers about
to consider the impact that language has reduced all-cause mortality risk (15), the benefits of DSMES and the critical
on building therapeutic relationships and healthy coping (16,17), and reduced times to refer (1), alternative and in-
to choose positive, strength-based words health care costs (18–20). Better out- novative models of DSMES delivery
and phrases that put people first (2,3). Pa- comes were reported for DSMES inter- need to be explored and evaluated.
tient performance of self-management ventions that were over 10 h in total
behaviors as well as psychosocial factors duration (11), included ongoing support Reimbursement
impacting the person’s self-management (5,21), were culturally (22,23) and age Medicare reimburses DSMES when that
should be monitored. Please see Section appropriate (24,25), were tailored to service meets the national standards
4, “Comprehensive Medical Evaluation individual needs and preferences, and ad- (1,4) and is recognized by the American
and Assessment of Comorbidities,” for dressed psychosocial issues and incorpo- Diabetes Association (ADA) or other ap-
more on use of language. rated behavioral strategies (6,16,26,27). proval bodies. DSMES is also covered by
DSMES and the current national stan- Individual and group approaches are most health insurance plans. Ongoing
dards guiding it (1,4) are based on evi- effective (13,28,29), with a slight benefit support has been shown to be instru-
dence of benefit. Specifically, DSMES realized by those who engage in both mental for improving outcomes when it
helps people with diabetes to identify (11). Emerging evidence demonstrates is implemented after the completion of
and implement effective self-manage- the benefit of Internet-based DSMES education services. DSMES is frequently
ment strategies and cope with diabetes services for diabetes prevention and reimbursed when performed in person.
at the four critical time points (described the management of type 2 diabetes However, although DSMES can also be
below) (1). Ongoing DSMES helps people (30–32). Technology-enabled diabe- provided via phone calls and telehealth,
with diabetes to maintain effective self- tes self-management solutions improve these remote versions may not always
management throughout a lifetime of A1C most effectively when there is be reimbursed. Changes in reimburse-
diabetes as they face new challenges two-way communication between the ment policies that increase DSMES ac-
and as advances in treatment become patient and the health care team, individ- cess and utilization will result in a positive
available (5). ualized feedback, use of patient-generated impact to beneficiaries’ clinical outcomes,
Four critical time points have been health data, and education (32). Current quality of life, health care utilization, and
defined when the need for DSMES is to research supports nurses, dietitians, and costs (47).
be evaluated by the medical care pro- pharmacists as providers of DSMES who
vider and/or multidisciplinary team, with may also develop curriculum (33–35). NUTRITION THERAPY
referrals made as needed (1): Members of the DSMES team should For many individuals with diabetes, the
have specialized clinical knowledge in most challenging part of the treat-
1. At diagnosis diabetes and behavior change principles. ment plan is determining what to eat and
2. Annually for assessment of education, Certification as a certified diabetes ed- following a meal plan. There is not a one-
nutrition, and emotional needs ucator (CDE) or board certified-advanced size-fits-all eating pattern for individuals
S48 Lifestyle Management Diabetes Care Volume 42, Supplement 1, January 2019

with diabetes, and meal planning should carbohydrate, protein, and fat for all peo- support one eating plan over another
be individualized. Nutrition therapy has ple with diabetes. Therefore, macronu- at this time.
an integral role in overall diabetes man- trient distribution should be based on A simple and effective approach to
agement, and each person with diabetes an individualized assessment of current glycemia and weight management em-
should be actively engaged in education, eating patterns, preferences, and meta- phasizing portion control and healthy
self-management, and treatment plan- bolic goals. Consider personal preferen- food choices should be considered for
ning with his or her health care team, ces (e.g., tradition, culture, religion, those with type 2 diabetes who are not
including the collaborative development health beliefs and goals, economics) as taking insulin, who have limited health
of an individualized eating plan (35,48). well as metabolic goals when working literacy or numeracy, or who are older
All individuals with diabetes should be with individuals to determine the best and prone to hypoglycemia (50). The
offered a referral for individualized MNT eating pattern for them (35,51,52). It is diabetes plate method is commonly
provided by a registered dietitian (RD) important that each member of the used for providing basic meal planning
who is knowledgeable and skilled in health care team be knowledgeable guidance (67) as it provides a visual guide
providing diabetes-specific MNT (49). about nutrition therapy principles for showing how to control calories (by
MNT delivered by an RD is associated people with all types of diabetes and featuring a smaller plate) and carbohy-
with A1C decreases of 1.0–1.9% for peo- be supportive of their implementation. drates (by limiting them to what fits in
ple with type 1 diabetes (50) and 0.3–2% Emphasis should be on healthful eat- one-quarter of the plate) and puts an
for people with type 2 diabetes (50). See ing patterns containing nutrient-dense emphasis on low-carbohydrate (or non-
Table 5.1 for specific nutrition recom- foods, with less focus on specific nu- starchy) vegetables.
mendations. Because of the progres- trients (53). A variety of eating patterns
sive nature of type 2 diabetes, lifestyle are acceptable for the management of Weight Management
changes alone may not be adequate to diabetes (51,54), and a referral to an RD Management and reduction of weight is
maintain euglycemia over time. How- or registered dietitian nutritionist (RDN) important for people with type 1 dia-
ever, after medication is initiated, nutri- is essential to assess the overall nutrition betes, type 2 diabetes, or prediabetes
tion therapy continues to be an important status of, and to work collaboratively who have overweight or obesity. Life-
component and should be integrated with, the patient to create a personalized style intervention programs should be
with the overall treatment plan (48). meal plan that considers the individual’s intensive and have frequent follow-up
health status, skills, resources, food pref- to achieve significant reductions in ex-
Goals of Nutrition Therapy for Adults erences, and health goals to coordinate cess body weight and improve clinical
With Diabetes and align with the overall treatment indicators. There is strong and consis-
1. To promote and support healthful plan including physical activity and med- tent evidence that modest persistent
eating patterns, emphasizing a variety ication. The Mediterranean (55,56), Di- weight loss can delay the progression
of nutrient-dense foods in appropri- etary Approaches to Stop Hypertension from prediabetes to type 2 diabetes
ate portion sizes, to improve overall (DASH) (57–59), and plant-based (60,61) (51,68,69) (see Section 3 “Prevention
health and: diets are all examples of healthful eat- or Delay of Type 2 Diabetes”) and is
○ Achieve and maintain body weight ing patterns that have shown positive beneficial to the management of type
goals results in research, but individualized 2 diabetes (see Section 8 “Obesity
○ Attain individualized glycemic, meal planning should focus on per- Management for the Treatment of
blood pressure, and lipid goals sonal preferences, needs, and goals. In Type 2 Diabetes”).
○ Delay or prevent the complica- addition, research indicates that low- Studies of reduced calorie interven-
tions of diabetes carbohydrate eating plans may result in tions show reductions in A1C of 0.3%
2. To address individual nutrition needs improved glycemia and have the poten- to 2.0% in adults with type 2 diabetes,
based on personal and cultural pref- tial to reduce antihyperglycemic medi- as well as improvements in medication
erences, health literacy and numeracy, cations for individuals with type 2 doses and quality of life (50,51). Sustain-
access to healthful foods, willing- diabetes (62–64). As research studies ing weight loss can be challenging (70,71)
ness and ability to make behavioral on some low-carbohydrate eating plans but has long-term benefits; maintaining
changes, and barriers to change generally indicate challenges with long- weight loss for 5 years is associated with
3. To maintain the pleasure of eating by term sustainability, it is important to sustained improvements in A1C and lipid
providing nonjudgmental messages reassess and individualize meal plan levels (72). Weight loss can be attained
about food choices guidance regularly for those interested with lifestyle programs that achieve a
4. To provide an individual with diabe- in this approach. This meal plan is not 500–750 kcal/day energy deficit or pro-
tes the practical tools for developing recommended at this time for women vide ;1,200–1,500 kcal/day for women
healthy eating patterns rather than who are pregnant or lactating, people and 1,500–1,800 kcal/day for men,
focusing on individual macronutrients, with or at risk for disordered eating, or adjusted for the individual’s baseline
micronutrients, or single foods people who have renal disease, and it body weight. For many obese individ-
should be used with caution in patients uals with type 2 diabetes, weight loss
Eating Patterns, Macronutrient taking sodium–glucose cotransporter of at least 5% is needed to produce
Distribution, and Meal Planning 2 (SGLT2) inhibitors due to the potential beneficial outcomes in glycemic con-
Evidence suggests that there is not risk of ketoacidosis (65,66). There is in- trol, lipids, and blood pressure (70).
an ideal percentage of calories from adequate research in type 1 diabetes to It should be noted, however, that the
care.diabetesjournals.org Lifestyle Management S49

Table 5.1—Medical nutrition therapy recommendations


Topic Recommendations Evidence rating
Effectiveness of 5.6 An individualized medical nutrition therapy program as needed to achieve treatment goals, A
nutrition therapy preferably provided by a registered dietitian, is recommended for all people with type 1 or type 2
diabetes, prediabetes, and gestational diabetes mellitus.
5.7 A simple and effective approach to glycemia and weight management emphasizing portion control B
and healthy food choices may be considered for those with type 2 diabetes who are not taking insulin,
who have limited health literacy or numeracy, or who are older and prone to hypoglycemia.
5.8 Because diabetes nutrition therapy can result in cost savings B and improved outcomes (e.g., B, A, E
A1C reduction) A, medical nutrition therapy should be adequately reimbursed by insurance and
other payers. E
Energy balance 5.9 Weight loss (.5%) achievable by the combination of reduction of calorie intake and lifestyle A
modification benefits overweight or obese adults with type 2 diabetes and also those with
prediabetes. Intervention programs to facilitate weight loss are recommended.
Eating patterns and 5.10 There is no single ideal dietary distribution of calories among carbohydrates, fats, and proteins for E
macronutrient people with diabetes; therefore, meal plans should be individualized while keeping total calorie
distribution and metabolic goals in mind.
5.11 A variety of eating patterns are acceptable for the management of type 2 diabetes and prediabetes. B
Carbohydrates 5.12 Carbohydrate intake should emphasize nutrient-dense carbohydrate sources that are high in fiber, B
including vegetables, fruits, legumes, whole grains, as well as dairy products.
5.13 For people with type 1 diabetes and those with type 2 diabetes who are prescribed a flexible insulin A, B
therapy program, education on how to use carbohydrate counting A and in some cases how to
consider fat and protein content B to determine mealtime insulin dosing is recommended to improve
glycemic control.
5.14 For individuals whose daily insulin dosing is fixed, a consistent pattern of carbohydrate intake with B
respect to time and amount may be recommended to improve glycemic control and reduce the risk
of hypoglycemia.
5.15 People with diabetes and those at risk are advised to avoid sugar-sweetened beverages (including B, A
fruit juices) in order to control glycemia and weight and reduce their risk for cardiovascular disease
and fatty liver B and should minimize the consumption of foods with added sugar that have the
capacity to displace healthier, more nutrient-dense food choices. A
Protein 5.16 In individuals with type 2 diabetes, ingested protein appears to increase insulin response without B
increasing plasma glucose concentrations. Therefore, carbohydrate sources high in protein should
be avoided when trying to treat or prevent hypoglycemia.
Dietary fat 5.17 Data on the ideal total dietary fat content for people with diabetes are inconclusive, so an eating B
plan emphasizing elements of a Mediterranean-style diet rich in monounsaturated and
polyunsaturated fats may be considered to improve glucose metabolism and lower cardiovascular
disease risk and can be an effective alternative to a diet low in total fat but relatively high in
carbohydrates.
5.18 Eating foods rich in long-chain n-3 fatty acids, such as fatty fish (EPA and DHA) and nuts and seeds B, A
(ALA), is recommended to prevent or treat cardiovascular disease B; however, evidence does not
support a beneficial role for the routine use of n-3 dietary supplements. A
Micronutrients and 5.19 There is no clear evidence that dietary supplementation with vitamins, minerals (such as C
herbal supplements chromium and vitamin D), herbs, or spices (such as cinnamon or aloe vera) can improve outcomes in
people with diabetes who do not have underlying deficiencies and they are not generally
recommended for glycemic control.
Alcohol 5.20 Adults with diabetes who drink alcohol should do so in moderation (no more than one drink C
per day for adult women and no more than two drinks per day for adult men).
5.21 Alcohol consumption may place people with diabetes at increased risk for hypoglycemia, especially B
if taking insulin or insulin secretagogues. Education and awareness regarding the recognition and
management of delayed hypoglycemia are warranted.
Sodium 5.22 As for the general population, people with diabetes should limit sodium consumption B
to ,2,300 mg/day.
Nonnutritive 5.23 The use of nonnutritive sweeteners may have the potential to reduce overall calorie and B
sweeteners carbohydrate intake if substituted for caloric (sugar) sweeteners and without compensation by intake
of additional calories from other food sources. For those who consume sugar-sweetened beverages
regularly, a low-calorie or nonnutritive-sweetened beverage may serve as a short-term replacement
strategy, but overall, people are encouraged to decrease both sweetened and nonnutritive-
sweetened beverages and use other alternatives, with an emphasis on water intake.

clinical benefits of weight loss are pro- on need, feasibility, and safety (73). structured weight loss plan, is strongly
gressive and more intensive weight MNT guidance from an RD/RDN with recommended.
loss goals (i.e., 15%) may be appropri- expertise in diabetes and weight man- Studies have demonstrated that a
ate to maximize benefit depending agement, throughout the course of a variety of eating plans, varying in
S50 Lifestyle Management Diabetes Care Volume 42, Supplement 1, January 2019

macronutrient composition, can be used low-carbohydrate eating plans generally control (51,82,93–96). Individuals who
effectively and safely in the short term indicate challenges with long-term sus- consume meals containing more protein
(1–2 years) to achieve weight loss in tainability, it is important to reassess and fat than usual may also need to make
people with diabetes. This includes struc- and individualize meal plan guidance mealtime insulin dose adjustments to
tured low-calorie meal plans that include regularly for those interested in this compensate for delayed postprandial
meal replacements (72–74) and the approach. Providers should maintain glycemic excursions (97–99). For individ-
Mediterranean eating pattern (75) as consistent medical oversight and recog- uals on a fixed daily insulin schedule,
well as low-carbohydrate meal plans nize that certain groups are not ap- meal planning should emphasize a rela-
(62). However, no single approach has propriate for low-carbohydrate eating tively fixed carbohydrate consumption
been proven to be consistently superior plans, including women who are preg- pattern with respect to both time and
(76,77), and more data are needed to nant or lactating, children, and people amount (35).
identify and validate those meal plans who have renal disease or disordered
that are optimal with respect to long- eating behavior, and these plans should Protein
term outcomes as well as patient ac- be used with caution for those taking There is no evidence that adjusting
ceptability. The importance of providing SGLT2 inhibitors due to potential risk the daily level of protein intake (typically
guidance on an individualized meal plan of ketoacidosis (65,66). There is inade- 1–1.5 g/kg body weight/day or 15–20%
containing nutrient-dense foods, such as quate research about dietary patterns total calories) will improve health in
vegetables, fruits, legumes, dairy, lean for type 1 diabetes to support one eating individuals without diabetic kidney dis-
sources of protein (including plant-based plan over another at this time. ease, and research is inconclusive re-
sources as well as lean meats, fish, and Most individuals with diabetes report garding the ideal amount of dietary
poultry), nuts, seeds, and whole grains, a moderate intake of carbohydrate (44– protein to optimize either glycemic con-
cannot be overemphasized (77), as well 46% of total calories) (51). Efforts to trol or cardiovascular disease (CVD)
as guidance on achieving the desired en- modify habitual eating patterns are risk (84,100). Therefore, protein intake
ergy deficit (78–81). Any approach to often unsuccessful in the long term; goals should be individualized based
meal planning should be individualized people generally go back to their usual on current eating patterns. Some re-
considering the health status, personal macronutrient distribution (51). Thus, search has found successful manage-
preferences, and ability of the person the recommended approach is to in- ment of type 2 diabetes with meal
with diabetes to sustain the recommen- dividualize meal plans to meet caloric plans including slightly higher levels of
dations in the plan. goals with a macronutrient distribution protein (20–30%), which may contribute
that is more consistent with the individ- to increased satiety (58).
Carbohydrates ual’s usual intake to increase the likeli- Those with diabetic kidney disease
Studies examining the ideal amount of hood for long-term maintenance. (with albuminuria and/or reduced esti-
carbohydrate intake for people with As for all individuals in developed mated glomerular filtration rate) should
diabetes are inconclusive, although moni- countries, both children and adults aim to maintain dietary protein at the
toring carbohydrate intake and consid- with diabetes are encouraged to mini- recommended daily allowance of 0.8
ering the blood glucose response to mize intake of refined carbohydrates g/kg body weight/day. Reducing the
dietary carbohydrate are key for improv- and added sugars and instead focus amount of dietary protein below the
ing postprandial glucose control (82,83). on carbohydrates from vegetables, le- recommended daily allowance is not
The literature concerning glycemic index gumes, fruits, dairy (milk and yogurt), recommended because it does not alter
and glycemic load in individuals with di- and whole grains. The consumption of glycemic measures, cardiovascular risk
abetes is complex, often yielding mixed sugar-sweetened beverages (including measures, or the rate at which glomer-
results, though in some studies lowering fruit juices) and processed “low-fat” ular filtration rate declines (101,102).
the glycemic load of consumed carbohy- or “nonfat” food products with high In individuals with type 2 diabetes,
drates has demonstrated A1C reductions amounts of refined grains and added protein intake may enhance or increase
of 0.2% to 0.5% (84,85). Studies longer sugars is strongly discouraged (90–92). the insulin response to dietary carbohy-
than 12 weeks report no significant in- Individuals with type 1 or type 2 di- drates (103). Therefore, use of carbohy-
fluence of glycemic index or glycemic load abetes taking insulin at mealtime should drate sources high in protein (such as
independent of weight loss on A1C; how- be offered intensive and ongoing edu- milk and nuts) to treat or prevent hypo-
ever, mixed results have been reported cation on the need to couple insulin glycemia should be avoided due to the
for fasting glucose levels and endoge- administration with carbohydrate in- potential concurrent rise in endogenous
nous insulin levels. take. For people whose meal schedule or insulin.
For people with type 2 diabetes or carbohydrate consumption is variable,
prediabetes, low-carbohydrate eating regular counseling to help them under- Fats
plans show potential to improve glyce- stand the complex relationship between The ideal amount of dietary fat for in-
mia and lipid outcomes for up to 1 year carbohydrate intake and insulin needs dividuals with diabetes is controversial.
(62–64,86–89). Part of the challenge in is important. In addition, education on The National Academy of Medicine has
interpreting low-carbohydrate research using the insulin-to-carbohydrate ratios defined an acceptable macronutrient
has been due to the wide range of def- for meal planning can assist them with distribution for total fat for all adults
initions for a low-carbohydrate eating effectively modifying insulin dosing from to be 20–35% of total calorie intake (104).
plan (85,86). As research studies on meal to meal and improving glycemic The type of fats consumed is more
care.diabetesjournals.org Lifestyle Management S51

important than total amount of fat when or peripheral neuropathy (123). Routine beverage may serve as a short-term re-
looking at metabolic goals and CVD risk, supplementation with antioxidants, such placement strategy, but overall, people
and it is recommended that the per- as vitamins E and C and carotene, is not are encouraged to decrease both sweet-
centage of total calories from saturated advised due to lack of evidence of effi- ened and nonnutritive-sweetened bever-
fats should be limited (75,90,105–107). cacy and concern related to long-term ages and use other alternatives, with an
Multiple randomized controlled trials safety. In addition, there is insufficient emphasis on water intake (132).
including patients with type 2 diabetes evidence to support the routine use of
have reported that a Mediterranean- herbals and micronutrients, such as cin- PHYSICAL ACTIVITY
style eating pattern (75,108–113), rich namon (124), curcumin, vitamin D (125),
Recommendations
in polyunsaturated and monounsatu- or chromium, to improve glycemia in
5.24 Children and adolescents with
rated fats, can improve both glycemic people with diabetes (35,126). However,
type 1 or type 2 diabetes or
control and blood lipids. However, sup- for special populations, including preg-
prediabetes should engage
plements do not seem to have the nant or lactating women, older adults,
in 60 min/day or more of mod-
same effects as their whole-food coun- vegetarians, and people following very
erate- or vigorous-intensity
terparts. A systematic review concluded low-calorie or low-carbohydrate diets, a
aerobic activity, with vigor-
that dietary supplements with n-3 fatty multivitamin may be necessary.
ous muscle-strengthening and
acids did not improve glycemic con-
bone-strengthening activities at
trol in individuals with type 2 diabe- Alcohol
least 3 days/week. C
tes (84). Randomized controlled trials Moderate alcohol intake does not have
5.25 Most adults with type 1 C and
also do not support recommending n-3 major detrimental effects on long-term
type 2 B diabetes should engage
supplements for primary or secondary blood glucose control in people with
in 150 min or more of moderate-
prevention of CVD (114–118). People diabetes. Risks associated with alcohol
to-vigorous intensity aerobic ac-
with diabetes should be advised to follow consumption include hypoglycemia (par-
tivity per week, spread over at
the guidelines for the general population ticularly for those using insulin or insulin
least 3 days/week, with no more
for the recommended intakes of satu- secretagogue therapies), weight gain,
than 2 consecutive days without
rated fat, dietary cholesterol, and trans and hyperglycemia (for those consuming
activity. Shorter durations (min-
fat (90). In general, trans fats should excessive amounts) (35,126). People with
imum 75 min/week) of vigorous-
be avoided. In addition, as saturated diabetes can follow the same guidelines
intensity or interval training may
fats are progressively decreased in the as those without diabetes if they choose
be sufficient for younger and
diet, they should be replaced with un- to drink. For women, no more than one
more physically fit individuals.
saturated fats and not with refined car- drink per day, and for men, no more than
5.26 Adults with type 1 C and type 2 B
bohydrates (112). two drinks per day is recommended (one
diabetes should engage in 2–3
drink is equal to a 12-oz beer, a 5-oz glass
sessions/week of resistance ex-
Sodium of wine, or 1.5 oz of distilled spirits).
ercise on nonconsecutive days.
As for the general population, people
5.27 All adults, and particularly those
with diabetes are advised to limit their Nonnutritive Sweeteners
with type 2 diabetes, should
sodium consumption to ,2,300 mg/day For some people with diabetes who are
decrease the amount of time
(35). Restriction below 1,500 mg, even accustomed to sugar-sweetened prod-
spent in daily sedentary behav-
for those with hypertension, is gener- ucts, nonnutritive sweeteners (con-
ior. B Prolonged sitting should
ally not recommended (119–121). So- taining few or no calories) may be an
be interrupted every 30 min for
dium intake recommendations should acceptable substitute for nutritive sweet-
blood glucose benefits, partic-
take into account palatability, availabil- eners (those containing calories such as
ularly in adults with type 2 di-
ity, affordability, and the difficulty of sugar, honey, agave syrup) when con-
abetes. C
achieving low-sodium recommenda- sumed in moderation. While use of
5.28 Flexibility training and balance
tions in a nutritionally adequate diet nonnutritive sweeteners does not ap-
training are recommended 2–3
(122). pear to have a significant effect on
times/week for older adults with
glycemic control (127), they can reduce
diabetes. Yoga and tai chi may
Micronutrients and Supplements overall calorie and carbohydrate intake
be included based on individual
There continues to be no clear evidence (51). Most systematic reviews and meta-
preferences to increase flexibility,
of benefit from herbal or nonherbal analyses show benefits for nonnutritive
muscular strength, and balance. C
(i.e., vitamin or mineral) supplementation sweetener use in weight loss (128,129);
for people with diabetes without un- however, some research suggests an
derlying deficiencies (35). Metformin is association with weight gain (130). Reg- Physical activity is a general term that
associated with vitamin B12 deficiency, ulatory agencies set acceptable daily includes all movement that increases
with a recent report from the Diabetes intake levels for each nonnutritive energy use and is an important part of
Prevention Program Outcomes Study sweetener, defined as the amount that the diabetes management plan. Exercise
(DPPOS) suggesting that periodic test- can be safely consumed over a person’s is a more specific form of physical ac-
ing of vitamin B12 levels should be lifetime (35,131). For those who consume tivity that is structured and designed
considered in patients taking metfor- sugar-sweetened beverages regularly, to improve physical fitness. Both phys-
min, particularly in those with anemia a low-calorie or nonnutritive-sweetened ical activity and exercise are important.
S52 Lifestyle Management Diabetes Care Volume 42, Supplement 1, January 2019

Exercise has been shown to improve 1 and type 2 diabetes and offers specific should be encouraged to reduce the
blood glucose control, reduce cardiovas- recommendation (142). amount of time spent being sedentary
cular risk factors, contribute to weight (e.g., working at a computer, watching
loss, and improve well-being (133). Phys- Exercise and Children TV) by breaking up bouts of sedentary
ical activity is as important for those with All children, including children with di- activity (.30 min) by briefly standing,
type 1 diabetes as it is for the general abetes or prediabetes, should be en- walking, or performing other light phys-
population, but its specific role in the couraged to engage in regular physical ical activities (150,151). Avoiding ex-
prevention of diabetes complications activity. Children should engage in at tended sedentary periods may help
and the management of blood glucose least 60 min of moderate-to-vigorous prevent type 2 diabetes for those at
is not as clear as it is for those with type aerobic activity every day with muscle- risk and may also aid in glycemic control
2 diabetes. A recent study suggested and bone-strengthening activities at for those with diabetes.
that the percentage of people with di- least 3 days per week (143). In general, A wide range of activities, includ-
abetes who achieved the recommended youth with type 1 diabetes benefit from ing yoga, tai chi, and other types, can
exercise level per week (150 min) var- being physically active, and an active have significant impacts on A1C, flexi-
ied by race. Objective measurement lifestyle should be recommended to all bility, muscle strength, and balance
by accelerometer showed that 44.2%, (144). Youth with type 1 diabetes who (133,152,153). Flexibility and balance
42.6%, and 65.1% of whites, African engage in more physical activity may exercises may be particularly important
Americans, and Hispanics, respectively, have better health-related quality of in older adults with diabetes to maintain
met the threshold (134). It is important life (145). range of motion, strength, and balance
for diabetes care management teams (142).
to understand the difficulty that many Frequency and Type of Physical
patients have reaching recommended Activity Physical Activity and Glycemic Control
treatment targets and to identify indi- People with diabetes should perform Clinical trials have provided strong evi-
vidualized approaches to improve goal aerobic and resistance exercise regularly dence for the A1C-lowering value of
achievement. (142). Aerobic activity bouts should ide- resistance training in older adults with
Moderate to high volumes of aerobic ally last at least 10 min, with the goal of type 2 diabetes (154) and for an additive
activity are associated with substantially ;30 min/day or more, most days of the benefit of combined aerobic and resis-
lower cardiovascular and overall mortal- week for adults with type 2 diabetes. tance exercise in adults with type 2
ity risks in both type 1 and type 2 diabetes Daily exercise, or at least not allowing diabetes (155). If not contraindicated,
(135). A recent prospective observa- more than 2 days to elapse between patients with type 2 diabetes should be
tional study of adults with type 1 diabetes exercise sessions, is recommended to encouraged to do at least two weekly
suggested that higher amounts of phys- decrease insulin resistance, regardless sessions of resistance exercise (exercise
ical activity led to reduced cardiovascular of diabetes type (146,147). Over time, with free weights or weight machines),
mortality after a mean follow-up time of activities should progress in intensity, with each session consisting of at least
11.4 years for patients with and without frequency, and/or duration to at least one set (group of consecutive repetitive
chronic kidney disease (136). Addition- 150 min/week of moderate-intensity ex- exercise motions) of five or more differ-
ally, structured exercise interventions ercise. Adults able to run at 6 miles/h ent resistance exercises involving the
of at least 8 weeks’ duration have been (9.7 km/h) for at least 25 min can benefit large muscle groups (154).
shown to lower A1C by an average of sufficiently from shorter-intensity activ- For type 1 diabetes, although exercise
0.66% in people with type 2 diabetes, even ity (75 min/week) (142). Many adults, in general is associated with improve-
without a significant change in BMI (137). including most with type 2 diabetes, ment in disease status, care needs to
There are also considerable data for the would be unable or unwilling to partic- be taken in titrating exercise with respect
health benefits (e.g., increased cardiovas- ipate in such intense exercise and should to glycemic management. Each individual
cular fitness, greater muscle strength, im- engage in moderate exercise for the with type 1 diabetes has a variable gly-
proved insulin sensitivity, etc.) of regular recommended duration. Adults with di- cemic response to exercise. This variabil-
exercise for those with type 1 diabetes abetes should engage in 2–3 sessions/ ity should be taken into consideration
(138). A recent study suggested that week of resistance exercise on noncon- when recommending the type and dura-
exercise training in type 1 diabetes secutive days (148). Although heavier tion of exercise for a given individual
may also improve several important resistance training with free weights (138).
markers such as triglyceride level, LDL, and weight machines may improve gly- Women with preexisting diabetes,
waist circumference, and body mass cemic control and strength (149), re- particularly type 2 diabetes, and those
(139). Higher levels of exercise intensity sistance training of any intensity is at risk for or presenting with gestational
are associated with greater improve- recommended to improve strength, bal- diabetes mellitus should be advised to
ments in A1C and in fitness (140). Other ance, and the ability to engage in activ- engage in regular moderate physical
benefits include slowing the decline in ities of daily living throughout the life activity prior to and during their preg-
mobility among overweight patients span. Providers and staff should help nancies as tolerated (142).
with diabetes (141). The ADA position patients set stepwise goals toward meet-
statement “Physical Activity/Exercise and ing the recommended exercise targets. Pre-exercise Evaluation
Diabetes” reviews the evidence for the Recent evidence supports that all in- As discussed more fully in Section
benefits of exercise in people with type dividuals, including those with diabetes, 10 “Cardiovascular Disease and Risk
care.diabetesjournals.org Lifestyle Management S53

Management,” the best protocol for Exercise in the Presence of Diabetic Kidney Disease
assessing asymptomatic patients with Microvascular Complications Physical activity can acutely increase uri-
diabetes for coronary artery disease re- See Section 11 “Microvascular Complica- nary albumin excretion. However, there is
mains unclear. The ADA consensus report tions and Foot Care” for more information no evidence that vigorous-intensity exer-
“Screening for Coronary Artery Disease on these long-term complications. cise increases the rate of progression of
in Patients With Diabetes” (156) con- Retinopathy diabetic kidney disease, and there appears
cluded that routine testing is not recom- If proliferative diabetic retinopathy or to be no need for specific exercise re-
mended. However, providers should severe nonproliferative diabetic retinop- strictions for people with diabetic kidney
perform a careful history, assess cardio- athy is present, then vigorous-intensity disease in general (158).
vascular risk factors, and be aware of aerobic or resistance exercise may be
the atypical presentation of coronary contraindicated because of the risk of
artery disease in patients with diabetes. SMOKING CESSATION: TOBACCO
triggering vitreous hemorrhage or ret- AND E-CIGARETTES
Certainly, high-risk patients should be inal detachment (158). Consultation
encouraged to start with short periods with an ophthalmologist prior to engag- Recommendations
of low-intensity exercise and slowly in- ing in an intense exercise regimen may 5.29 Advise all patients not to use
crease the intensity and duration as be appropriate. cigarettes and other tobacco
tolerated. Providers should assess pa- products A or e-cigarettes. B
Peripheral Neuropathy
tients for conditions that might contra- 5.30 Include smoking cessation coun-
indicate certain types of exercise or Decreased pain sensation and a higher
seling and other forms of treat-
predispose to injury, such as uncontrolled pain threshold in the extremities result
ment as a routine component
in an increased risk of skin breakdown,
hypertension, untreated proliferative ret- of diabetes care. A
inopathy, autonomic neuropathy, periph- infection, and Charcot joint destruction
eral neuropathy, and a history of foot with some forms of exercise. Therefore, a Results from epidemiological, case-control,
ulcers or Charcot foot. The patient’s age thorough assessment should be done to and cohort studies provide convincing
and previous physical activity level should ensure that neuropathy does not alter evidence to support the causal link be-
be considered. The provider should cus- kinesthetic or proprioceptive sensation tween cigarette smoking and health risks
tomize the exercise regimen to the indi- during physical activity, particularly in (163). Recent data show tobacco use is
vidual’s needs. Those with complications those with more severe neuropathy. Stud- higher among adults with chronic con-
may require a more thorough evaluation ies have shown that moderate-intensity ditions (164) as well as in adolescents
prior to beginning an exercise program walking may not lead to an increased risk and young adults with diabetes (165).
(138). of foot ulcers or reulceration in those with Smokers with diabetes (and people
peripheral neuropathy who use proper with diabetes exposed to second-hand
footwear (159). In addition, 150 min/week smoke) have a heightened risk of CVD,
Hypoglycemia
In individuals taking insulin and/or in- of moderate exercise was reported to premature death, microvascular com-
sulin secretagogues, physical activity may improve outcomes in patients with plications, and worse glycemic control
cause hypoglycemia if the medication prediabetic neuropathy (160). All indi- when compared with nonsmokers
dose or carbohydrate consumption is viduals with peripheral neuropathy (166,167). Smoking may have a role in
not altered. Individuals on these thera- should wear proper footwear and ex- the development of type 2 diabetes
pies may need to ingest some added amine their feet daily to detect lesions (168–171).
carbohydrate if pre-exercise glucose lev- early. Anyone with a foot injury or open The routine and thorough assessment
els are ,90 mg/dL (5.0 mmol/L), depend- sore should be restricted to non–weight- of tobacco use is essential to prevent
ing on whether they are able to lower bearing activities. smoking or encourage cessation. Nu-
insulin doses during the workout (such as Autonomic Neuropathy merous large randomized clinical trials
with an insulin pump or reduced pre- Autonomic neuropathy can increase the have demonstrated the efficacy and
exercise insulin dosage), the time of day risk of exercise-induced injury or adverse cost-effectiveness of brief counseling
exercise is done, and the intensity and events through decreased cardiac re- in smoking cessation, including the
duration of the activity (138,142). In sponsiveness to exercise, postural hy- use of telephone quit lines, in reducing
some patients, hypoglycemia after ex- potension, impaired thermoregulation, tobacco use. Pharmacologic therapy to
ercise may occur and last for several impaired night vision due to impaired assist with smoking cessation in people
hours due to increased insulin sensitiv- papillary reaction, and greater suscepti- with diabetes has been shown to be
ity. Hypoglycemia is less common in bility to hypoglycemia (161). Cardiovas- effective (172), and for the patient mo-
patients with diabetes who are not cular autonomic neuropathy is also an tivated to quit, the addition of pharma-
treated with insulin or insulin secreta- independent risk factor for cardiovascu- cologic therapy to counseling is more
gogues, and no routine preventive mea- lar death and silent myocardial ische- effective than either treatment alone
sures for hypoglycemia are usually mia (162). Therefore, individuals with (173). Special considerations should in-
advised in these cases. Intense activities diabetic autonomic neuropathy should clude assessment of level of nicotine
may actually raise blood glucose levels undergo cardiac investigation before dependence, which is associated with
instead of lowering them, especially if beginning physical activity more in- difficulty in quitting and relapse (174).
pre-exercise glucose levels are elevated tense than that to which they are Although some patients may gain weight
(157). accustomed. in the period shortly after smoking
S54 Lifestyle Management Diabetes Care Volume 42, Supplement 1, January 2019

cessation (175), recent research has dem- psychological vulnerability at diagno-


disordered eating, and cogni-
onstrated that this weight gain does not sis, when their medical status changes
tive capacities using patient-
diminish the substantial CVD benefit re- (e.g., end of the honeymoon period),
appropriate standardized and
alized from smoking cessation (176). One when the need for intensified treat-
validated tools at the initial
study in smokers with newly diagnosed ment is evident, and when complica-
visit, at periodic intervals, and
type 2 diabetes found that smoking tions are discovered.
when there is a change in dis-
cessation was associated with amelio- Providers can start with informal
ease, treatment, or life circum-
ration of metabolic parameters and re- verbal inquires, for example, by asking
stance. Including caregivers and
duced blood pressure and albuminuria if there have been changes in mood
family members in this assess-
at 1 year (177). during the past 2 weeks or since the
ment is recommended. B
In recent years e-cigarettes have patient’s last visit. Providers should con-
5.34 Consider screening older adults
gained public awareness and popularity sider asking if there are new or different
(aged $65 years) with diabetes
because of perceptions that e-cigarette barriers to treatment and self-manage-
for cognitive impairment and
use is less harmful than regular cigarette ment, such as feeling overwhelmed or
depression. B
smoking (178,179). Nonsmokers should stressed by diabetes or other life stres-
be advised not to use e-cigarettes sors. Standardized and validated tools for
Please refer to the ADA position state-
(180,181). There are no rigorous studies psychosocial monitoring and assessment
ment “Psychosocial Care for People With
that have demonstrated that e-cigarettes can also be used by providers (187), with
Diabetes” for a list of assessment tools
are a healthier alternative to smoking
and additional details (187). positive findings leading to referral to a
or that e-cigarettes can facilitate smok- mental health provider specializing in
Complex environmental, social, be-
ing cessation (182). On the contrary, a diabetes for comprehensive evaluation,
havioral, and emotional factors, known
recently published pragmatic trial found diagnosis, and treatment.
as psychosocial factors, influence living
that use of e-cigarettes for smoking
with diabetes, both type 1 and type 2,
cessation was not more effective than
and achieving satisfactory medical out-
“usual care,” which included access to Diabetes Distress
comes and psychological well-being. Thus,
educational information on the health
individuals with diabetes and their fam- Recommendation
benefits of smoking cessation, strategies
ilies are challenged with complex, multi- 5.35 Routinely monitor people with
to promote cessation, and access to a
faceted issues when integrating diabetes diabetes for diabetes distress,
free text-messaging service that pro-
care into daily life. particularly when treatment tar-
vided encouragement, advice, and tips
Emotional well-being is an important gets are not met and/or at the
to facilitate smoking cessation (183). Sev-
part of diabetes care and self-management. onset of diabetes complications. B
eral organizations have called for more
Psychological and social problems can
research on the short- and long-term
impair the individual’s (188–190) or fam- Diabetes distress (DD) is very common
safety and health effects of e-cigarettes
ily’s (191) ability to carry out diabetes care and is distinct from other psychological
(184–186).
tasks and therefore potentially compro- disorders (193–195). DD refers to signif-
mise health status. There are opportu- icant negative psychological reactions
nities for the clinician to routinely assess related to emotional burdens and wor-
PSYCHOSOCIAL ISSUES
psychosocial status in a timely and effi- ries specific to an individual’s experience
Recommendations cient manner for referral to appropri- in having to manage a severe, compli-
5.31 Psychosocial care should be in- ate services. A systematic review and cated, and demanding chronic disease
tegrated with a collaborative, meta-analysis showed that psychosocial such as diabetes (194–196). The constant
patient-centered approach and interventions modestly but significantly behavioral demands (medication dos-
provided to all people with di- improved A1C (standardized mean dif- ing, frequency, and titration; monitoring
abetes, with the goals of op- ference –0.29%) and mental health blood glucose, food intake, eating pat-
timizing health outcomes and outcomes (192). However, there was a terns, and physical activity) of diabetes
health-related quality of life. A limited association between the effects
self-management and the potential or
5.32 Psychosocial screening and on A1C and mental health, and no in-
actuality of disease progression are di-
follow-up may include, but are tervention characteristics predicted
rectly associated with reports of DD
not limited to, attitudes about benefit on both outcomes.
(194). The prevalence of DD is reported
diabetes, expectations for
to be 18–45% with an incidence of
medical management and out-
Screening 38–48% over 18 months (196). In the
comes, affect or mood, general
Key opportunities for psychosocial screen- second Diabetes Attitudes, Wishes and
and diabetes-related quality of
ing occur at diabetes diagnosis, during Needs (DAWN2) study, significant DD
life, available resources (finan-
regularly scheduled management vis- was reported by 45% of the participants,
cial, social, and emotional), and
its, during hospitalizations, with new but only 24% reported that their health
psychiatric history. E
onset of complications, or when prob- care teams asked them how diabetes
5.33 Providers should consider assess-
lems with glucose control, quality of affected their lives (193). High levels
ment for symptoms of diabe-
life, or self-management are identi- of DD significantly impact medication-
tes distress, depression, anxiety,
fied (1). Patients are likely to exhibit taking behaviors and are linked to higher
care.diabetesjournals.org Lifestyle Management S55

Table 5.2—Situations that warrant referral of a person with diabetes to a mental health provider for evaluation and treatment
c If self-care remains impaired in a person with diabetes distress after tailored diabetes education
c If a person has a positive screen on a validated screening tool for depressive symptoms
c In the presence of symptoms or suspicions of disordered eating behavior, an eating disorder, or disrupted patterns of eating
c If intentional omission of insulin or oral medication to cause weight loss is identified
c If a person has a positive screen for anxiety or fear of hypoglycemia
c If a serious mental illness is suspected
c In youth and families with behavioral self-care difficulties, repeated hospitalizations for diabetic ketoacidosis, or significant distress
c If a person screens positive for cognitive impairment
c Declining or impaired ability to perform diabetes self-care behaviors
c Before undergoing bariatric or metabolic surgery and after surgery if assessment reveals an ongoing need for adjustment support

A1C, lower self-efficacy, and poorer di- psychological status to occur (26,193). with diabetes: a consensus report. Diabetes
etary and exercise behaviors (17,194, Providers should identify behavioral and Care 2013;36:463–470
7. Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau
196). DSMES has been shown to reduce mental health providers, ideally those
MM. Self-management education for adults
DD (17). It may be helpful to provide who are knowledgeable about diabetes with type 2 diabetes: a meta-analysis of the
counseling regarding expected diabetes- treatment and the psychosocial aspects of effect on glycemic control. Diabetes Care 2002;
related versus generalized psychological diabetes, to whom they can refer patients. 25:1159–1171
distress at diagnosis and when disease The ADA provides a list of mental health 8. Haas L, Maryniuk M, Beck J, et al.; 2012
Standards Revision Task Force. National stan-
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272
care team to a behavioral health pro- of the patient accepting referral for other 11. Chrvala CA, Sherr D, Lipman RD. Diabetes
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and management. Diabetes Metab Res Rev with and without diabetes. JAMA 2013;309:1014– and Needs second study (DAWN2Ô): cross-
2011;27:639–653 1021 national benchmarking indicators for family
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members living with people with diabetes. Dia- 195. Fisher L, Glasgow RE, Strycker LA. The 199. Gary TL, Safford MM, Gerzoff RB, et al.
bet Med 2013;30:778–788 relationship between diabetes distress and clin- Perception of neighborhood problems, health
192. Harkness E, Macdonald W, Valderas J, ical depression with glycemic control among behaviors, and diabetes outcomes among
Coventry P, Gask L, Bower P. Identifying psycho- patients with type 2 diabetes. Diabetes Care adults with diabetes in managed care: the
social interventions that improve both physical 2010;33:1034–1036 Translating Research Into Action for Diabe-
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in type 2 diabetes. Diabetes Care 2012;35:2472–
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2478
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197. Fisher L, Skaff MM, Mullan JT, et al. Clinical
Wishes and Needs second study (DAWN2Ô): ing type 2 diabetic patients’ social and emotional
cross-national benchmarking of diabetes-related depression versus distress among patients with difficulties: a qualitative study. Diabetes Care
psychosocial outcomes for people with diabetes. type 2 diabetes: not just a question of semantics. 2011;34:1086–1088
Diabet Med 2013;30:767–777 Diabetes Care 2007;30:542–548 201. Huang Y, Wei X, Wu T, Chen R, Guo A.
194. Fisher L, Hessler DM, Polonsky WH, Mullan 198. Snoek FJ, Bremmer MA, Hermanns N. Con- Collaborative care for patients with depres-
J. When is diabetes distress clinically mean- structs of depression and distress in diabetes: sion and diabetes mellitus: a systematic review
ingful?: establishing cut points for the Diabetes time for an appraisal. Lancet Diabetes Endocrinol and meta-analysis. BMC Psychiatry 2013;13:
Distress Scale. Diabetes Care 2012;35:259–264 2015;3:450–460 260
Diabetes Care Volume 42, Supplement 1, January 2019 S61

6. Glycemic Targets: Standards of American Diabetes Association

Medical Care in Diabetesd2019


Diabetes Care 2019;42(Suppl. 1):S61–S70 | https://doi.org/10.2337/dc19-S006

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”


includes ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee, are responsible for updating the Standards of
Care annually, or more frequently as warranted. For a detailed description of ADA

6. GLYCEMIC TARGETS
standards, statements, and reports, as well as the evidence-grading system for
ADA’s clinical practice recommendations, please refer to the Standards of Care
Introduction. Readers who wish to comment on the Standards of Care are invited to
do so at professional.diabetes.org/SOC.

ASSESSMENT OF GLYCEMIC CONTROL


Glycemic management is primarily assessed with the A1C test, which was the measure
studied in clinical trials demonstrating the benefits of improved glycemic control.
Patient self-monitoring of blood glucose (SMBG) may help with self-management and
medication adjustment, particularly in individuals taking insulin. Continuous glucose
monitoring (CGM) also has an important role in assessing the effectiveness and safety
of treatment in many patients with type 1 diabetes, and limited data suggest it may
also be helpful in selected patients with type 2 diabetes, such as those on intensive
insulin regimens (1).

A1C Testing

Recommendations
6.1 Perform the A1C test at least two times a year in patients who are meeting
treatment goals (and who have stable glycemic control). E
6.2 Perform the A1C test quarterly in patients whose therapy has changed or
who are not meeting glycemic goals. E
6.3 Point-of-care testing for A1C provides the opportunity for more timely
treatment changes. E

A1C reflects average glycemia over approximately 3 months. The performance of the
test is generally excellent for NGSP-certified assays (www.ngsp.org). The test is the Suggested citation: American Diabetes Associa-
major tool for assessing glycemic control and has strong predictive value for diabetes tion. 6. Glycemic targets: Standards of Medical
complications (1–3). Thus, A1C testing should be performed routinely in all patients Care in Diabetesd2019. Diabetes Care 2019;
with diabetesdat initial assessment and as part of continuing care. Measurement 42(Suppl. 1):S61–S70
approximately every 3 months determines whether patients’ glycemic targets have © 2018 by the American Diabetes Association.
been reached and maintained. The frequency of A1C testing should depend on the Readers may use this article as long as the work
is properly cited, the use is educational and not
clinical situation, the treatment regimen, and the clinician’s judgment. The use of for profit, and the work is not altered. More infor-
point-of-care A1C testing may provide an opportunity for more timely treatment mation is available at http://www.diabetesjournals
changes during encounters between patients and providers. Patients with type 2 .org/content/license.
S62 Glycemic Targets Diabetes Care Volume 42, Supplement 1, January 2019

diabetes with stable glycemia well A1C and Mean Glucose significant interference may explain a
within target may do well with A1C Table 6.1 shows the correlation between report that for any level of mean glyce-
testing only twice per year. Unstable A1C levels and mean glucose levels based mia, African Americans heterozygous for
or intensively managed patients (e.g., on two studies: the international A1C- the common hemoglobin variant HbS
pregnant women with type 1 diabetes) Derived Average Glucose (ADAG) study, had lower A1C by about 0.3 percentage
may require testing more frequently which assessed the correlation between points when compared with those with-
than every 3 months (4). A1C and frequent SMBG and CGM in out the trait (10,11). Another genetic
507 adults (83% non-Hispanic whites) variant, X-linked glucose-6-phosphate
A1C Limitations with type 1, type 2, and no diabetes (6), dehydrogenase G202A, carried by 11%
The A1C test is an indirect measure of and an empirical study of the average of African Americans, was associated
average glycemia and, as such, is subject blood glucose levels at premeal, post- with a decrease in A1C of about 0.8%
to limitations. As with any laboratory meal, and bedtime associated with spec- in hemizygous men and 0.7% in homo-
test, there is variability in the measure- ified A1C levels using data from the ADAG zygous women compared with those
ment of A1C. Although such variability trial (7). The American Diabetes Associ- without the trait (12).
is less on an intraindividual basis than ation (ADA) and the American Associa- A small study comparing A1C to CGM
that of blood glucose measurements, clini- tion for Clinical Chemistry have determined data in children with type 1 diabetes
cians should exercise judgment when that the correlation (r 5 0.92) in the ADAG found a highly statistically significant
using A1C as the sole basis for assessing trial is strong enough to justify reporting correlation between A1C and mean
glycemic control, particularly if the result both the A1C result and the estimated blood glucose, although the correla-
is close to the threshold that might average glucose (eAG) result when a cli- tion (r 5 0.7) was significantly lower
prompt a change in medication therapy. nician orders the A1C test. Clinicians than in the ADAG trial (13). Whether
Conditions that affect red blood cell should note that the mean plasma glu- there are clinically meaningful differ-
turnover (hemolytic and other anemias, cose numbers in the table are based on ences in how A1C relates to average
glucose-6-phosphate dehydrogenase ;2,700 readings per A1C in the ADAG glucose in children or in different
deficiency, recent blood transfusion, trial. In a recent report, mean glucose ethnicities is an area for further study
use of drugs that stimulate erythropoesis, measured with CGM versus central (8,14,15). Until further evidence is
end-stage kidney disease, and pregnancy) laboratory–measured A1C in 387 par- available, it seems prudent to estab-
may result in discrepancies between ticipants in three randomized trials lish A1C goals in these populations
the A1C result and the patient’s true demonstrated that A1C may underesti- with consideration of both individual-
mean glycemia. Hemoglobin variants mate or overestimate mean glucose (5). ized SMBG and A1C results.
must be considered, particularly when Thus, as suggested, a patient’s CGM
the A1C result does not correlate with profile has considerable potential for Glucose Assessment
the patient’s SMBG levels. However, optimizing his or her glycemic manage- For many people with diabetes, glucose
most assays in use in the U.S. are accurate ment (5). monitoring is key for the achievement of
in individuals heterozygous for the most glycemic targets. Major clinical trials of
common variants (www.ngsp.org/interf A1C Differences in Ethnic Populations and insulin-treated patients have included
.asp). Other measures of average gly- Children SMBG as part of multifactorial inter-
cemia such as fructosamine and 1,5- In the ADAG study, there were no sig- ventions to demonstrate the benefit of
anhydroglucitol are available, but their nificant differences among racial and intensive glycemic control on diabetes
translation into average glucose levels ethnic groups in the regression lines complications (16). SMBG is thus an in-
and their prognostic significance are not between A1C and mean glucose, al- tegral component of effective therapy of
as clear as for A1C. Though some vari- though the study was underpowered patients taking insulin. In recent years,
ability in the relationship between av- to detect a difference and there was CGM has emerged as a complementary
erage glucose levels and A1C exists a trend toward a difference between method for the assessment of glucose
among different individuals, generally the African/African American and non- levels. Glucose monitoring allows pa-
the association between mean glucose Hispanic white cohorts, with higher tients to evaluate their individual re-
and A1C within an individual correlates A1C values observed in Africans/African sponse to therapy and assess whether
over time (5). Americans compared with non-Hispanic glycemic targets are being safely
A1C does not provide a measure of whites for a given mean glucose. Other achieved. Integrating results into diabe-
glycemic variability or hypoglycemia. For studies have also demonstrated higher tes management can be a useful tool
patients prone to glycemic variability, A1C levels in African Americans than in for guiding medical nutrition therapy
especially patients with type 1 diabetes whites at a given mean glucose concen- and physical activity, preventing hypo-
or type 2 diabetes with severe insulin tration (8,9). glycemia, and adjusting medications (par-
deficiency, glycemic control is best eval- A1C assays are available that do not ticularly prandial insulin doses). The
uated by the combination of results from demonstrate a statistically significant patient’s specific needs and goals should
SMBG or CGM and A1C. A1C may also difference in individuals with hemoglo- dictate SMBG frequency and timing or
inform the accuracy of the patient’s bin variants. Other assays have statisti- the consideration of CGM use. Please
meter (or the patient’s reported SMBG cally significant interference, but the refer to Section 7 “Diabetes Technology”
results) and the adequacy of the SMBG difference is not clinically significant. for a fuller discussion of the use of SMBG
testing schedule. Use of an assay with such statistically and CGM.
care.diabetesjournals.org Glycemic Targets S63

A1C GOALS

was 0.92 (6).


are based on ADAG data of ;2,700 glucose measurements over 3 months per A1C measurement in 507 adults with type 1, type 2, and no diabetes. The correlation between A1C and average glucose
Data in parentheses represent 95% CI, unless otherwise noted. A calculator for converting A1C results into eAG, in either mg/dL or mmol/L, is available at http://professional.diabetes.org/eAG. *These estimates
12 (108)
11 (97)
10 (86)
9 (75)
8.0–8.5 (64–69)
8 (64)
7.5–7.99 (58–64)
7.0–7.49 (53–58)
7 (53)
6.5–6.99 (47–53)
5.5–6.49 (37–47)
6 (42)
% (mmol/mol)
A1C
Table 6.1—Mean glucose levels for specified A1C levels (6,7)
For glycemic goals in older adults, please
refer to Section 12 “Older Adults.” For
glycemic goals in children, please refer to
Section 13 “Children and Adolescents.”
For glycemic goals in pregnant women,
please refer to Section 14 “Management
298 (240–347)
269 (217–314)
240 (193–282)
212 (170–249)

183 (147–217)

154 (123–185)

126 (100–152)
of Diabetes in Pregnancy.”

mg/dL
Mean plasma glucose*
Recommendations
6.4 A reasonable A1C goal for many
nonpregnant adults is ,7% (53
16.5 (13.3–19.3)
14.9 (12.0–17.5)
13.4 (10.7–15.7)
11.8 (9.4–13.9)

10.2 (8.1–12.1)

mmol/mol). A
8.6 (6.8–10.3)

7.0 (5.5–8.5)
mmol/L
6.5 Providers might reasonably sug-
gest more stringent A1C goals
(such as ,6.5% [48 mmol/mol])
for selected individual patients if
this can be achieved without sig-
178 (164–192)

167 (157–177)
152 (143–162)

142 (135–150)
122 (117–127)

nificant hypoglycemia or other


mg/dL
Mean fasting glucose adverse effects of treatment
(i.e., polypharmacy). Appropriate
patients might include those with
short duration of diabetes, type 2
9.9 (9.1–10.7)

9.3 (8.7–9.8)
8.4 (7.9–9.0)

7.9 (7.5–8.3)
6.8 (6.5–7.0)

diabetes treated with lifestyle or


mmol/L

metformin only, long life expec-


tancy, or no significant cardiovas-
cular disease. C
6.6 Less stringent A1C goals (such
179 (167–191)

155 (148–161)
152 (147–157)

139 (134–144)
118 (115–121)

as ,8% [64 mmol/mol]) may


mg/dL
Mean premeal glucose

be appropriate for patients


with a history of severe hypogly-
cemia, limited life expectancy,
advanced microvascular or macro-
9.9 (9.3–10.6)

8.6 (8.2–8.9)
8.4 (8.2–8.7)

7.7 (7.4–8.0)
6.5 (6.4–6.7)

vascular complications, exten-


mmol/L

sive comorbid conditions, or


long-standing diabetes in whom
the goal is difficult to achieve de-
spite diabetes self-management
206 (195–217)

189 (180–197)
176 (170–183)

164 (159–169)
144 (139–148)

education, appropriate glucose


mg/dL

monitoring, and effective doses


Mean postmeal glucose

of multiple glucose-lowering
agents including insulin. B
6.7 Reassess glycemic targets over
11.4 (10.8–12.0)

10.5 (10.0–10.9)

time based on the criteria in


9.8 (9.4–10.2)

9.1 (8.8–9.4)
8.0 (7.7–8.2)

Fig. 6.1 or, in older adults, Table


mmol/L

12.1. E

A1C and Microvascular Complications


222 (197–248)

175 (163–188)
177 (166–188)

153 (145–161)
136 (131–141)

Hyperglycemia defines diabetes, and gly-


mg/dL

cemic control is fundamental to diabetes


Mean bedtime glucose

management. The Diabetes Control and


Complications Trial (DCCT) (16), a pro-
spective randomized controlled trial of
12.3 (10.9–13.8)

intensive (mean A1C about 7% [53


9.7 (9.0–10.4)
9.8 (9.2–10.4)

8.5 (8.0–8.9)
7.5 (7.3–7.8)

mmol/mol]) versus standard (mean


mmol/L

A1C about 9% [75 mmol/mol]) glycemic


control in patients with type 1 diabetes,
showed definitively that better gly-
cemic control is associated with 50–76%
S64 Glycemic Targets Diabetes Care Volume 42, Supplement 1, January 2019

Figure 6.1—Depicted are patient and disease factors used to determine optimal A1C targets. Characteristics and predicaments toward the left justify
more stringent efforts to lower A1C; those toward the right suggest less stringent efforts. A1C 7% 5 53 mmol/mol. Adapted with permission from
Inzucchi et al. (40).

reductions in rates of development and instituted early in the course of dis- MR Controlled Evaluation [ADVANCE], and
progression of microvascular (retinopa- ease. Epidemiologic analyses of the Veterans Affairs Diabetes Trial [VADT])
thy, neuropathy, and diabetic kidney DCCT (16) and UKPDS (23) demonstrate were conducted to test the effects of
disease) complications. Follow-up of the a curvilinear relationship between A1C near normalization of blood glucose on
DCCT cohorts in the Epidemiology of and microvascular complications. Such cardiovascular outcomes in individuals
Diabetes Interventions and Complica- analyses suggest that, on a population with long-standing type 2 diabetes and
tions (EDIC) study (17,18) demonstrated level, the greatest number of complica- either known cardiovascular disease
persistence of these microvascular ben- tions will be averted by taking patients (CVD) or high cardiovascular risk. These
efits over two decades despite the fact from very poor control to fair/good con- trials showed that lower A1C levels were
that the glycemic separation between trol. These analyses also suggest that associated with reduced onset or pro-
the treatment groups diminished and further lowering of A1C from 7% to gression of some microvascular compli-
disappeared during follow-up. 6% [53 mmol/mol to 42 mmol/mol] is cations (24–26).
The Kumamoto Study (19) and UK associated with further reduction in The concerning mortality findings in
Prospective Diabetes Study (UKPDS) the risk of microvascular complications, the ACCORD trial (27), discussed be-
(20,21) confirmed that intensive glyce- although the absolute risk reductions low, and the relatively intense efforts
mic control significantly decreased rates become much smaller. Given the sub- required to achieve near euglycemia
of microvascular complications in pa- stantially increased risk of hypoglycemia should also be considered when setting
tients with short-duration type 2 diabe- in type 1 diabetes trials and with poly- glycemic targets for individuals with long-
tes. Long-term follow-up of the UKPDS pharmacy in type 2 diabetes, the risks standing diabetes such as those stud-
cohorts showed enduring effects of early of lower glycemic targets may outweigh ied in ACCORD, ADVANCE, and VADT.
glycemic control on most microvascular the potential benefits on microvascular Findings from these studies suggest
complications (22). complications. caution is needed in treating diabetes
Therefore, achieving A1C targets of Three landmark trials (Action to Con- aggressively to near-normal A1C goals
,7% (53 mmol/mol) has been shown trol Cardiovascular Risk in Diabetes in people with long-standing type 2 di-
to reduce microvascular complications [ACCORD], Action in Diabetes and Vas- abetes with or at significant risk of CVD.
of type 1 and type 2 diabetes when cular Disease: Preterax and Diamicron However, on the basis of physician
care.diabetesjournals.org Glycemic Targets S65

judgment and patient preferences, select more advanced type 2 diabetes than or advanced age/frailty may benefit from
patients, especially those with little co- UKPDS participants. All three trials were less aggressive targets (36,37).
morbidity and long life expectancy, may conducted in relatively older participants As discussed further below, severe
benefit from adopting more intensive with longer known duration of diabetes hypoglycemia is a potent marker of
glycemic targets (e.g., A1C target ,6.5% (mean duration 8–11 years) and either high absolute risk of cardiovascular
[48 mmol/mol]) if they can achieve it CVD or multiple cardiovascular risk fac- events and mortality (38). Providers
safely without hypoglycemia or signifi- tors. The target A1C among intensive- should be vigilant in preventing hypo-
cant therapeutic burden. control subjects was ,6% (42 mmol/mol) glycemia and should not aggressively
in ACCORD, ,6.5% (48 mmol/mol) in attempt to achieve near-normal A1C
ADVANCE, and a 1.5% reduction in A1C levels in patients in whom such targets
A1C and Cardiovascular Disease compared with control subjects in VADT, cannot be safely and reasonably achieved.
Outcomes with achieved A1C of 6.4% vs. 7.5% As discussed in Section 9 “Pharmaco-
Cardiovascular Disease and Type 1 Diabetes (46 mmol/mol vs. 58 mmol/mol) in logic Approaches to Glycemic Treatment,”
CVD is a more common cause of death ACCORD, 6.5% vs. 7.3% (48 mmol/mol addition of specific sodium–glucose co-
than microvascular complications in pop- vs. 56 mmol/mol) in ADVANCE, and 6.9% transporter 2 inhibitors (SGLT2i) or
ulations with diabetes. There is evidence vs. 8.4% (52 mmol/mol vs. 68 mmol/mol) glucagon-like peptide 1 receptor ago-
for a cardiovascular benefit of intensive in VADT. Details of these studies are nists (GLP-1 RA) to improve cardiovascular
glycemic control after long-term follow- reviewed extensively in “Intensive Gly- outcomes in patients with established
up of cohorts treated early in the course cemic Control and the Prevention of CVD is indicated with consideration of
of type 1 diabetes. In the DCCT, there Cardiovascular Events: Implications of glycemic goals. If the patient is not at A1C
was a trend toward lower risk of CVD the ACCORD, ADVANCE, and VA Diabe- target, continue metformin unless con-
events with intensive control. In the tes Trials” (31). traindicated and add SGLT2i or GLP-1 RA
9-year post-DCCT follow-up of the EDIC The glycemic control comparison in with proven cardiovascular benefit. If the
cohort, participants previously random- ACCORD was halted early due to an patient is meeting A1C target, consider
ized to the intensive arm had a sig- increased mortality rate in the intensive one of three strategies (39):
nificant 57% reduction in the risk of compared with the standard treatment
nonfatal myocardial infarction (MI), stroke, arm (1.41% vs. 1.14% per year; hazard 1. If already on dual therapy or multiple
or cardiovascular death compared with ratio 1.22 [95% CI 1.01–1.46]), with a glucose-lowering therapies and not
those previously randomized to the stan- similar increase in cardiovascular deaths. on an SGLT2i or GLP-1 RA, consider
dard arm (28). The benefit of intensive Analysis of the ACCORD data did not switching to one of these agents with
glycemic control in this cohort with type 1 identify a clear explanation for the excess proven cardiovascular benefit.
diabetes has been shown to persist for mortality in the intensive treatment arm 2. Reconsider/lower individualized A1C
several decades (29) and to be associated (27). target and introduce SGLT2i or GLP-1
with a modest reduction in all-cause Longer-term follow-up has shown no RA.
mortality (30). evidence of cardiovascular benefit or 3. Reassess A1C at 3-month intervals and
Cardiovascular Disease and Type 2 Diabetes harm in the ADVANCE trial (32). The add SGLT2i or GLP-1 RA if A1C goes
In type 2 diabetes, there is evidence that end-stage renal disease rate was lower above target.
more intensive treatment of glycemia in in the intensive treatment group over
newly diagnosed patients may reduce follow-up. However, 10-year follow-up Setting and Modifying A1C Goals
long-term CVD rates. During the UKPDS, of the VADT cohort (33) showed a reduc- Numerous factors must be considered
there was a 16% reduction in CVD events tion in the risk of cardiovascular events when setting glycemic targets. The ADA
(combined fatal or nonfatal MI and sud- (52.7 [control group] vs. 44.1 [intervention proposes general targets appropriate
den death) in the intensive glycemic group] events per 1,000 person-years) for many patients but emphasizes the
control arm that did not reach statistical with no benefit in cardiovascular or over- importance of individualization based
significance (P 5 0.052), and there was all mortality. Heterogeneity of mortality on key patient characteristics. Glycemic
no suggestion of benefit on other CVD effects across studies was noted, which targets must be individualized in the
outcomes (e.g., stroke). However, after may reflect differences in glycemic tar- context of shared decision making to
10 years of observational follow-up, gets, therapeutic approaches, and pop- address the needs and preferences of
those originally randomized to inten- ulation characteristics (34). each patient and the individual charac-
sive glycemic control had significant Mortality findings in ACCORD (27) and teristics that influence risks and benefits
long-term reductions in MI (15% with subgroup analyses of VADT (35) suggest of therapy for each patient.
sulfonylurea or insulin as initial pharma- that the potential risks of intensive gly- The factors to consider in individual-
cotherapy, 33% with metformin as initial cemic control may outweigh its benefits izing goals are depicted in Fig. 6.1. Figure
pharmacotherapy) and in all-cause mor- in higher-risk patients. In all three trials, 6.1 is not designed to be applied rigidly
tality (13% and 27%, respectively) (22). severe hypoglycemia was significantly but to be used as a broad construct to
ACCORD, ADVANCE, and VADT sug- more likely in participants who were guide clinical decision making (40) in both
gested no significant reduction in CVD randomly assigned to the intensive gly- type 1 and type 2 diabetes. More strin-
outcomes with intensive glycemic con- cemic control arm. Those patients with gent control (such as an A1C of 6.5% [48
trol in participants followed for shorter long duration of diabetes, a known history mmol/mol] or ,7% [53 mmol/mol]) may
durations (3.5–5.6 years) and who had of hypoglycemia, advanced atherosclerosis, be recommended if it can be achieved
S66 Glycemic Targets Diabetes Care Volume 42, Supplement 1, January 2019

safely and with acceptable burden of preprandial versus postprandial SMBG may be relaxed without undermining
therapy and if life expectancy is sufficient targets is complex (41). Elevated post- overall glycemic control as measured
to reap benefits of tight control. Less challenge (2-h oral glucose tolerance by A1C. These data prompted the re-
stringent control (A1C up to 8% [64 test) glucose values have been associated vision in the ADA-recommended premeal
mmol/mol]) may be recommended if with increased cardiovascular risk inde- glucose target to 80–130 mg/dL (4.4–
the life expectancy of the patient is pendent of fasting plasma glucose in 7.2 mmol/L) but did not affect the def-
such that the benefits of an intensive some epidemiologic studies, but inter- inition of hypoglycemia.
goal may not be realized, or if the risks vention trials have not shown postpran-
and burdens outweigh the potential dial glucose to be a cardiovascular risk HYPOGLYCEMIA
benefits. Severe or frequent hypoglyce- factor independent of A1C. In subjects
Recommendations
mia is an absolute indication for the with diabetes, surrogate measures of
6.8 Individuals at risk for hypogly-
modification of treatment regimens, in- vascular pathology, such as endothelial
cemia should be asked about
cluding setting higher glycemic goals. dysfunction, are negatively affected by
symptomatic and asymptom-
Diabetes is a chronic disease that postprandial hyperglycemia. It is clear
atic hypoglycemia at each en-
progresses over decades. Thus, a goal that postprandial hyperglycemia, like
counter. C
that might be appropriate for an indi- preprandial hyperglycemia, contributes
6.9 Glucose (15–20 g) is the preferred
vidual early in the course of the disease to elevated A1C levels, with its relative
treatment for the conscious in-
may change over time. Newly diag- contribution being greater at A1C levels
dividual with blood glucose
nosed patients and/or those without that are closer to 7% (53 mmol/mol).
,70 mg/dL [3.9 mmol/L]),
comorbidities that limit life expectancy However, outcome studies have clearly
although any form of carbo-
may benefit from intensive control shown A1C to be the primary predictor
hydrate that contains glucose
proven to prevent microvascular compli- of complications, and landmark trials of
may be used. Fifteen minutes
cations. Both DCCT/EDIC and UKPDS glycemic control such as the DCCT and
after treatment, if SMBG shows
demonstrated metabolic memory, or a UKPDS relied overwhelmingly on pre-
continued hypoglycemia, the
legacy effect, in which a finite period of prandial SMBG. Additionally, a random-
treatment should be repeated.
intensive control yielded benefits that ized controlled trial in patients with
Once SMBG returns to normal,
extended for decades after that control known CVD found no CVD benefit of
the individual should consume
ended. Thus, a finite period of intensive insulin regimens targeting postprandial
a meal or snack to prevent re-
control to near-normal A1C may yield glucose compared with those targeting
currence of hypoglycemia. E
enduring benefits even if control is preprandial glucose (42). Therefore, it is
6.10 Glucagon should be prescribed
subsequently deintensified as patient reasonable for postprandial testing to be
for all individuals at increased
characteristics change. Over time, co- recommended for individuals who have
risk of level 2 hypoglycemia,
morbidities may emerge, decreasing premeal glucose values within target but
defined as blood glucose ,54
life expectancy and the potential to have A1C values above target. Mea-
mg/dL (3.0 mmol/L), so it is
reap benefits from intensive control. suring postprandial plasma glucose
available should it be needed.
Also, with longer duration of disease, 1–2 h after the start of a meal and
Caregivers, school personnel,
diabetes may become more difficult to using treatments aimed at reducing
or family members of these
control, with increasing risks and bur- postprandial plasma glucose values
individuals should know where
dens of therapy. Thus, A1C targets to ,180 mg/dL (10.0 mmol/L) may
it is and when and how to ad-
should be reevaluated over time to help to lower A1C.
minister it. Glucagon administra-
balance the risks and benefits as pa- An analysis of data from 470 partici-
tion is not limited to health care
tient factors change. pants in the ADAG study (237 with type 1
professionals. E
Recommended glycemic targets for diabetes and 147 with type 2 diabetes)
6.11 Hypoglycemia unawareness or
many nonpregnant adults are shown found that actual average glucose levels
one or more episodes of level
in Table 6.2. The recommendations in- associated with conventional A1C targets
3 hypoglycemia should trigger
clude blood glucose levels that appear to were higher than older DCCT and ADA
reevaluation of the treatment
correlate with achievement of an A1C targets (Table 6.1) (7,43). These findings
regimen. E
of ,7% (53 mmol/mol). The issue of support that premeal glucose targets
6.12 Insulin-treated patients with hy-
poglycemia unawareness or an
Table 6.2—Summary of glycemic recommendations for many nonpregnant episode of level 2 hypoglycemia
adults with diabetes should be advised to raise their
A1C ,7.0% (53 mmol/mol)* glycemic targets to strictly avoid
Preprandial capillary plasma glucose 80–130 mg/dL* (4.4–7.2 mmol/L) hypoglycemia for at least several
Peak postprandial capillary plasma glucose† ,180 mg/dL* (10.0 mmol/L) weeks in order to partially re-
*More or less stringent glycemic goals may be appropriate for individual patients. Goals should verse hypoglycemia unaware-
be individualized based on duration of diabetes, age/life expectancy, comorbid conditions, ness and reduce risk of future
known CVD or advanced microvascular complications, hypoglycemia unawareness, and individual
patient considerations. †Postprandial glucose may be targeted if A1C goals are not met despite
episodes. A
reaching preprandial glucose goals. Postprandial glucose measurements should be made 1–2 h 6.13 Ongoing assessment of cogni-
after the beginning of the meal, generally peak levels in patients with diabetes. tive function is suggested with
care.diabetesjournals.org Glycemic Targets S67

Table 6.3—Classification of hypoglycemia (44) are noted as particularly vulnerable to


Level Glycemic criteria/description
hypoglycemia because of their reduced
ability to recognize hypoglycemic symp-
Level 1 Glucose ,70 mg/dL (3.9 mmol/L) and glucose $54 mg/dL
toms and effectively communicate their
(3.0 mmol/L)
needs. Individualized glucose targets,
Level 2 Glucose ,54 mg/dL (3.0 mmol/L)
patient education, dietary intervention
Level 3 A severe event characterized by altered mental and/or
(e.g., bedtime snack to prevent overnight
physical status requiring assistance
hypoglycemia when specifically needed
to treat low blood glucose), exercise
management, medication adjustment,
glucose monitoring, and routine clinical
cohort of older black and white adults with surveillance may improve patient out-
increased vigilance for hypogly-
type 2 diabetes include insulin use, poor or comes (54). CGM with automated low
cemia by the clinician, patient,
moderate versus good glycemic control, glucose suspend has been shown to be
and caregivers if low cognition or
albuminuria, and poor cognitive function effective in reducing hypoglycemia in
declining cognition is found. B
(46). type 1 diabetes (55). For patients with
Symptoms of hypoglycemia include, type 1 diabetes with level 3 hypoglyce-
Hypoglycemia is the major limiting fac- but are not limited to, shakiness, irrita- mia and hypoglycemia unawareness that
tor in the glycemic management of bility, confusion, tachycardia, and hun- persists despite medical treatment,
type 1 and type 2 diabetes. Recommen- ger. Hypoglycemia may be inconvenient human islet transplantation may be an
dations regarding the classification of or frightening to patients with diabetes. option, but the approach remains ex-
hypoglycemia are outlined in Table 6.3 Level 3 hypoglycemia may be recognized perimental (56,57).
(44). Level 1 hypoglycemia is defined as a or unrecognized and can progress to loss In 2015, the ADA changed its prepran-
measurable glucose concentration ,70 of consciousness, seizure, coma, or dial glycemic target from 70–130 mg/dL
mg/dL (3.9 mmol/L) but $54 mg/dL death. It is reversed by administration (3.9–7.2 mmol/L) to 80–130 mg/dL (4.4–
(3.0 mmol/L). A blood glucose concentra- of rapid-acting glucose or glucagon. Hy- 7.2 mmol/L). This change reflects the
tion of 70 mg/dL (3.9 mmol/L) has been poglycemia can cause acute harm to the results of the ADAG study, which dem-
recognized as a threshold for neuroen- person with diabetes or others, espe- onstrated that higher glycemic targets
docrine responses to falling glucose in cially if it causes falls, motor vehicle corresponded to A1C goals (7). An ad-
people without diabetes. Because many accidents, or other injury. A large cohort ditional goal of raising the lower range of
people with diabetes demonstrate im- study suggested that among older adults the glycemic target was to limit over-
paired counterregulatory responses to with type 2 diabetes, a history of level 3 treatment and provide a safety margin in
hypoglycemia and/or experience hypo- hypoglycemia was associated with greater patients titrating glucose-lowering drugs
glycemia unawareness, a measured glu- risk of dementia (48). Conversely, in a such as insulin to glycemic targets.
cose level ,70 mg/dL (3.9 mmol/L) is substudy of the ACCORD trial, cognitive
considered clinically important, indepen- impairment at baseline or decline in
dent of the severity of acute hypoglycemic cognitive function during the trial was Hypoglycemia Treatment
symptoms. Level 2 hypoglycemia (de- significantly associated with subsequent Providers should continue to counsel
fined as a blood glucose concentra- episodes of level 3 hypoglycemia (49). patients to treat hypoglycemia with
tion ,54 mg/dL [3.0 mmol/L]) is the Evidence from DCCT/EDIC, which involved fast-acting carbohydrates at the hy-
threshold at which neuroglycopenic adolescents and younger adults with type 1 poglycemia alert value of 70 mg/dL
symptoms begin to occur and requires diabetes, found no association between (3.9 mmol/L) or less. Hypoglycemia treat-
immediate action to resolve the hypo- frequency of level 3 hypoglycemia and ment requires ingestion of glucose- or
glycemic event. Lastly, level 3 hypogly- cognitive decline (50), as discussed in carbohydrate-containing foods. The acute
cemia is defined as a severe event Section 13 “Children and Adolescents.” glycemic response correlates better with
characterized by altered mental and/or Level 3 hypoglycemia was associated the glucose content of food than with
physical functioning that requires assis- with mortality in participants in both the the carbohydrate content of food. Pure
tance from another person for recovery. standard and the intensive glycemia arms glucose is the preferred treatment, but
Studies of rates of level 3 hypoglyce- of the ACCORD trial, but the relationships any form of carbohydrate that contains
mia that rely on claims data for hospi- between hypoglycemia, achieved A1C, glucose will raise blood glucose. Added
talization, emergency department visits, and treatment intensity were not straight- fat may retard and then prolong the
and ambulance use substantially under- forward. An association of level 3 hypo- acute glycemic response. In type 2 di-
estimate rates of level 3 hypoglycemia glycemia with mortality was also found in abetes, ingested protein may increase
(45), yet find high burden of hypoglyce- the ADVANCE trial (51). An association insulin response without increasing
mia in adults over 60 years of age in the between self-reported level 3 hypoglyce- plasma glucose concentrations (58).
community (46). African Americans are mia and 5-year mortality has also been Therefore, carbohydrate sources high
at substantially increased risk of level 3 reported in clinical practice (52) in protein should not be used to treat
hypoglycemia (46,47). In addition to age Young children with type 1 diabetes or prevent hypoglycemia. Ongoing in-
and race, other important risk factors and the elderly, including those with sulin activity or insulin secretagogues
found in a community-based epidemiologic type 1 and type 2 diabetes (48,53), may lead to recurrent hypoglycemia
S68 Glycemic Targets Diabetes Care Volume 42, Supplement 1, January 2019

unless more food is ingested after re- clinically significant hypoglycemia may 5. Beck RW, Connor CG, Mullen DM, Wesley
covery. Once the glucose returns to benefit from at least short-term relaxa- DM, Bergenstal RM. The fallacy of average:
how using HbA1c alone to assess glycemic
normal, the individual should be coun- tion of glycemic targets. control can be misleading. Diabetes Care
seled to eat a meal or snack to prevent 2017;40:994–999
recurrent hypoglycemia. INTERCURRENT ILLNESS 6. Nathan DM, Kuenen J, Borg R, Zheng H,
For further information on management Schoenfeld D, Heine RJ; A1c-Derived Average
Glucagon of patients with hyperglycemia in the Glucose Study Group. Translating the A1C assay
The use of glucagon is indicated for the into estimated average glucose values. Diabetes
hospital, please refer to Section 15 Care 2008;31:1473–1478
treatment of hypoglycemia in people “Diabetes Care in the Hospital.” 7. Wei N, Zheng H, Nathan DM. Empirically
unable or unwilling to consume carbo- Stressful events (e.g., illness, trauma, establishing blood glucose targets to achieve
hydrates by mouth. Those in close con- surgery, etc.) may worsen glycemic con- HbA1c goals. Diabetes Care 2014;37:1048–1051
tact with, or having custodial care of, trol and precipitate diabetic ketoacidosis 8. Selvin E. Are there clinical implications of
people with hypoglycemia-prone diabe- racial differences in HbA1c? A difference, to
or nonketotic hyperglycemic hyper- be a difference, must make a difference. Diabe-
tes (family members, roommates, school osmolar state, life-threatening conditions tes Care 2016;39:1462–1467
personnel, child care providers, correc- that require immediate medical care to 9. Bergenstal RM, Gal RL, Connor CG, et al.; T1D
tional institution staff, or coworkers) prevent complications and death. Any Exchange Racial Differences Study Group. Racial
should be instructed on the use of glu- condition leading to deterioration in gly- differences in the relationship of glucose con-
cagon kits, including where the kit is and centrations and hemoglobin A1c levels. Ann In-
cemic control necessitates more frequent tern Med 2017;167:95–102
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care professional to safely administer monitoring. If accompanied by ketosis, A1c in African Americans. JAMA 2017;317:507–
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ventional treatment and risk of complications in VADT Investigators. Follow-up of glycemic con- emergency department and hospital utilization
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1998;352:837–853 abetes. N Engl J Med 2015;372:2197–2206 46. Lee AK, Lee CJ, Huang ES, Sharrett AR, Coresh
22. Holman RR, Paul SK, Bethel MA, Matthews 34. Turnbull FM, Abraira C, Anderson RJ, et al.; J, Selvin E. Risk factors for severe hypoglycemia
DR, Neil HAW. 10-year follow-up of intensive Control Group. Intensive glucose control and in black and white adults with diabetes: the
glucose control in type 2 diabetes. N Engl J macrovascular outcomes in type 2 diabetes Atherosclerosis Risk in Communities (ARIC)
Med 2008;359:1577–1589 [published correction appears in Diabetologia study. Diabetes Care 2017;40:1661–1667
23. Adler AI, Stratton IM, Neil HAW, et al. 2009;52:2470]. Diabetologia 2009;52:2288–2298 47. Karter AJ, Lipska KJ, O’Connor PJ, et al.;
Association of systolic blood pressure with 35. Duckworth WC, Abraira C, Moritz TE, et al.; SUPREME-DM Study Group. High rates of severe
macrovascular and microvascular complications Investigators of the VADT. The duration of di- hypoglycemia among African American patients
of type 2 diabetes (UKPDS 36): prospective abetes affects the response to intensive glucose with diabetes: the SUrveillance, PREvention, and
observational study. BMJ 2000;321:412–419 control in type 2 subjects: the VA Diabetes Trial. ManagEment of Diabetes Mellitus (SUPREME-DM)
24. Duckworth W, Abraira C, Moritz T, et al.; J Diabetes Complications 2011;25:355–361 network. J Diabetes Complications 2017;31:
VADT Investigators. Glucose control and vascular 36. Lipska KJ, Ross JS, Miao Y, Shah ND, Lee SJ, 869–873
complications in veterans with type 2 diabetes. Steinman MA. Potential overtreatment of di- 48. Whitmer RA, Karter AJ, Yaffe K, Quesenberry
N Engl J Med 2009;360:129–139 abetes mellitus in older adults with tight CP Jr, Selby JV. Hypoglycemic episodes and risk of
25. Patel A, MacMahon S, Chalmers J, et al.; glycemic control. JAMA Intern Med 2015;175: dementia in older patients with type 2 diabetes
ADVANCE Collaborative Group. Intensive blood 356–362 mellitus. JAMA 2009;301:1565–1572
glucose control and vascular outcomes in pa- 37. Vijan S, Sussman JB, Yudkin JS, Hayward 49. Punthakee Z, Miller ME, Launer LJ, et al.;
tients with type 2 diabetes. N Engl J Med 2008; RA. Effect of patients’ risks and preferences ACCORD Group of Investigators; ACCORD-MIND
358:2560–2572 on health gains with plasma glucose level lowering Investigators. Poor cognitive function and
26. Ismail-Beigi F, Craven T, Banerji MA, et al.; in type 2 diabetes mellitus. JAMA Intern Med risk of severe hypoglycemia in type 2 dia-
ACCORD trial group. Effect of intensive treat- 2014;174:1227–1234 betes: post hoc epidemiologic analysis of
ment of hyperglycaemia on microvascular 38. Lee AK, Warren B, Lee CJ, et al. The asso- the ACCORD trial. Diabetes Care 2012;35:
outcomes in type 2 diabetes: an analysis of ciation of severe hypoglycemia with incident 787–793
the ACCORD randomised trial. Lancet 2010; cardiovascular events and mortality in adults 50. Jacobson AM, Musen G, Ryan CM, et al.;
376:419–430 with type 2 diabetes. Diabetes Care 2018;41: Diabetes Control and Complications Trial/
27. Gerstein HC, Miller ME, Byington RP, et al.; 104–111 Epidemiology of Diabetes Interventions and
Action to Control Cardiovascular Risk in Diabe- 39. Davies MJ, D’Alessio DA, Fradkin J, et al. Complications Study Research Group. Long-
tes Study Group. Effects of intensive glucose Management of hyperglycemia in type 2 diabe- term effect of diabetes and its treatment on
lowering in type 2 diabetes. N Engl J Med 2008; tes, 2018. A consensus report by the American cognitive function. N Engl J Med 2007;356:
358:2545–2559 Diabetes Association (ADA) and the European 1842–1852
28. Nathan DM, Cleary PA, Backlund J-YC, Association for the Study of Diabetes (EASD). 51. Zoungas S, Patel A, Chalmers J, et al.;
et al.; Diabetes Control and Complications Trial/ Diabetes Care 2018;41:2669–2701 ADVANCE Collaborative Group. Severe hypo-
Epidemiology of Diabetes Interventions and 40. Inzucchi SE, Bergenstal RM, Buse JB, et al. glycemia and risks of vascular events and death.
Complications (DCCT/EDIC) Study Research Management of hyperglycemia in type 2 diabe- N Engl J Med 2010;363:1410–1418
Group. Intensive diabetes treatment and car- tes, 2015: a patient-centered approach: update 52. McCoy RG, Van Houten HK, Ziegenfuss JY,
diovascular disease in patients with type 1 di- to a position statement of the American Diabetes Shah ND, Wermers RA, Smith SA. Increased
abetes. N Engl J Med 2005;353:2643–2653 Association and the European Association for the mortality of patients with diabetes reporting
29. Nathan DM, Zinman B, Cleary PA, et al.; Study of Diabetes. Diabetes Care 2015;38:140– severe hypoglycemia. Diabetes Care 2012;35:
Diabetes Control and Complications Trial/ 149 1897–1901
Epidemiology of Diabetes Interventions and 41. American Diabetes Association. Postpran- 53. DuBose SN, Weinstock RS, Beck RW, et al.
Complications (DCCT/EDIC) Research Group. dial blood glucose. Diabetes Care 2001;24:775– Hypoglycemia in older adults with type 1 di-
Modern-day clinical course of type 1 diabetes 778 abetes. Diabetes Technol Ther 2016;18:765–
mellitus after 30 years’ duration: the Diabetes 42. Raz I, Wilson PWF, Strojek K, et al. Effects 771
Control and Complications Trial/Epidemiology of of prandial versus fasting glycemia on cardio- 54. Seaquist ER, Anderson J, Childs B, et al.
Diabetes Interventions and Complications and vascular outcomes in type 2 diabetes: the Hypoglycemia and diabetes: a report of a work-
Pittsburgh Epidemiology of Diabetes Complica- HEART2D trial. Diabetes Care 2009;32:381– group of the American Diabetes Association and
tions experience (1983–2005). Arch Intern Med 386 the Endocrine Society. Diabetes Care 2013;36:
2009;169:1307–1316 43. Albers JW, Herman WH, Pop-Busui R, et al.; 1384–1395
30. Orchard TJ, Nathan DM, Zinman B, et al.; Diabetes Control and Complications Trial/Epide- 55. Bergenstal RM, Klonoff DC, Garg SK, et al.;
Writing Group for the DCCT/EDIC Research miology of Diabetes Interventions and Compli- ASPIRE In-Home Study Group. Threshold-
Group. Association between 7 years of intensive cations Research Group. Effect of prior intensive based insulin-pump interruption for reduction
treatment of type 1 diabetes and long-term insulin treatment during the Diabetes Control of hypoglycemia. N Engl J Med 2013;369:224–
mortality. JAMA 2015;313:45–53 and Complications Trial (DCCT) on peripheral 232
31. Skyler JS, Bergenstal R, Bonow RO, et al.; neuropathy in type 1 diabetes during the Epi- 56. Hering BJ, Clarke WR, Bridges ND, et al.;
American Diabetes Association; American demiology of Diabetes Interventions and Clinical Islet Transplantation Consortium.
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Phase 3 trial of transplantation of human islets caveat emptor. Diabetes Care 2016;39:1072– 59. Cryer PE. Diverse causes of hypoglycemia-
in type 1 diabetes complicated by severe hy- 1074 associated autonomic failure in diabetes. N Engl J
poglycemia. Diabetes Care 2016;39:1230– 58. Layman DK, Clifton P, Gannon MC, Krauss Med 2004;350:2272–2279
1240 RM, Nuttall FQ. Protein in optimal health: heart 60. Kitabchi AE, Umpierrez GE, Miles JM, Fisher
57. Harlan DM. Islet transplantation for hy- disease and type 2 diabetes. Am J Clin Nutr 2008; JN. Hyperglycemic crises in adult patients with
poglycemia unawareness/severe hypoglycemia: 87:1571S–1575S diabetes. Diabetes Care 2009;32:1335–1343
Diabetes Care Volume 42, Supplement 1, January 2019 S71

7. Diabetes Technology: Standards American Diabetes Association

of Medical Care in Diabetesd2019


Diabetes Care 2019;42(Suppl. 1):S71–S80 | https://doi.org/10.2337/dc19-S007

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”


includes ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee, are responsible for updating the Standards of
Care annually, or more frequently as warranted. For a detailed description of ADA

7. DIABETES TECHNOLOGY
standards, statements, and reports, as well as the evidence-grading system for
ADA’s clinical practice recommendations, please refer to the Standards of Care
Introduction. Readers who wish to comment on the Standards of Care are invited to
do so at professional.diabetes.org/SOC.

Diabetes technology is the term used to describe the hardware, devices, and software
that people with diabetes use to help manage blood glucose levels, stave off diabetes
complications, reduce the burden of living with diabetes, and improve quality of life.
Historically, diabetes technology has been divided into two main categories: insulin
administered by syringe, pen, or pump, and blood glucose monitoring as assessed
by meter or continuous glucose monitor. More recently, diabetes technology has
expanded to include hybrid devices that both monitor glucose and deliver insulin,
some automatically, as well as software that serves as a medical device, providing
diabetes self-management support. Diabetes technology, when applied appropri-
ately, can improve the lives and health of people with diabetes; however, the
complexity and rapid change of the diabetes technology landscape can also be a
barrier to patient and provider implementation.
To provide some additional clarity in the diabetes technology space, the American
Diabetes Association is, for the first time, adding a dedicated section on diabetes
technology to the “Standards of Medical Care in Diabetes.” For this first writing, the
section will focus on insulin delivery and glucose monitoring with the most common
devices currently in use. In future years, this section will be expanded to include
software as a medical device, privacy, cost, technology-enabled diabetes education
and support, telemedicine, and other issues that providers and patients encounter
with the use of technology in modern diabetes care.

INSULIN DELIVERY
Insulin Syringes and Pens Suggested citation: American Diabetes Associa-
Recommendations tion. 7. Diabetes technology: Standards of Med-
ical Care in Diabetesd2019. Diabetes Care 2019;42
7.1 For people with diabetes who require insulin, insulin syringes or insulin pens (Suppl. 1):S71–S80
may be used for insulin delivery with consideration of patient preference,
© 2018 by the American Diabetes Association.
insulin type and dosing regimen, cost, and self-management capabilities. B Readers may use this article as long as the work
7.2 Insulin pens or insulin injection aids may be considered for patients with is properly cited, the use is educational and not
dexterity issues or vision impairment to facilitate the administration of for profit, and the work is not altered. More infor-
accurate insulin doses. C mation is available at http://www.diabetesjournals
.org/content/license.
S72 Diabetes Technology Diabetes Care Volume 42, Supplement 1, January 2019

Injecting insulin with a syringe or pen is quickly, while a thinner needle may cause based upon the individual characteristics
the insulin delivery method used by most less pain. Needle length ranges from 4 to of the patient and which is most likely to
people with diabetes (1,2), with the re- 12.7 mm, with some evidence suggesting benefit him or her. Newer systems, such
mainder using insulin pumps or auto- shorter needles may lower the risk of as sensor-augmented pumps and auto-
mated insulin delivery devices (see intramuscular injection. When reused, matic insulin delivery systems, are dis-
sections on those topics below). For needles may be duller and thus injection cussed elsewhere in this section.
patients with diabetes who use insulin, more painful. Proper insulin technique is Adoption of pump therapy in the U.S.
insulin syringes and pens are both able a requisite to obtain the full benefits of shows geographical variations, which
to deliver insulin safely and effectively insulin injection therapy, and concerns with may be related to provider prefer-
for the achievement of glycemic tar- technique and using the proper technique ence or center characteristics (10,11)
gets. When choosing between a syringe are outlined in Section 9 “Pharmacologic and socioeconomic status, as pump ther-
and a pen, patient preferences, cost, Approaches to Glycemic Treatment.” apy is more common in individuals of
insulin type and dosing regimen, and Another insulin delivery option is a higher socioeconomic status as re-
self-management capabilities should disposable patch-like device, which pro- flected by race/ethnicity, private health
be considered. It is important to note vides a continuous, subcutaneous infu- insurance, family income, and education
that while many insulin types are avail- sion of rapid-acting insulin (basal), as (11,12). Given the additional barriers to
able for purchase as either pens or vials, well as 2-unit increments of bolus insulin optimal diabetes care observed in dis-
others may only be available in one form at the press of a button (7). advantaged groups (13), addressing the
or the other and there may be significant differences in access to insulin pumps
cost differences between pens and vials and other diabetes technology may con-
Insulin Pumps
(see Table 9.3 for a list of insulin product tribute to fewer health disparities.
costs with dosage forms). Insulin pens Recommendations Pump therapy can be successfully
may allow people with vision impairment 7.3 Individuals with diabetes who started at the time of diagnosis (14,15).
or dexterity issues to dose insulin accu- have been successfully using con- Practical aspects of pump therapy initi-
rately (3–5), while insulin injection aids tinuous subcutaneous insulin in- ation include: assessment of patient and
are also available to help with these fusion should have continued family readiness, (although there is no con-
issues (http://main.diabetes.org/dforg/ access across third-party payers. E sensus on which factors to consider in
pdfs/2018/2018-cg-injection-aids.pdf). 7.4 Most adults, children, and adoles- adults (16) or pediatrics), selection of pump
The most common syringe sizes are cents with type 1 diabetes should type and initial pump settings, patient/
1 mL, 0.5 mL, and 0.3 mL, allowing doses of be treated with intensive insulin family education of potential pump com-
up to 100 units, 50 units, and 30 units of therapy with either multiple daily plications (e.g., diabetic ketoacidosis [DKA]
U-100 insulin, respectively. In a few parts injections or an insulin pump. A with infusion set failure), transition from
of the world, insulin syringes still have 7.5 Insulin pump therapy may be con- MDI, and introduction of advanced pump
U-80 and U-40 markings for older insulin sidered as an option for all chil- settings (e.g., temporary basal rates,
concentrations and veterinary insulin, and dren and adolescents, especially in extended/square/dual wave bolus).
U-500 syringes are available for the use of children under 7 years of age. C Complications of the pump can be
U-500 insulin. Syringes are generally used caused by issues with infusion sets
once but may be reused by the same in- Continuous subcutaneous insulin injec- (dislodgement, occlusion), which place
dividual in resource-limited settings with tion (CSII) or insulin pumps have been patients at risk for ketosis and DKA and
appropriate storage and cleansing (6). available in the U.S. for 40 years. These thus must be recognized and managed
Insulin pens offer added convenience devices deliver rapid-acting insulin early (17); lipohypertrophy or, less fre-
by combining the vial and syringe into a throughout the day to help manage quently, lipoatrophy (18,19); and pump
single device. Insulin pens, allowing push- blood glucose levels. Most insulin pumps site infection (20). Discontinuation of
button injections, come as disposable use tubing to deliver insulin through a pump therapy is relatively uncommon
pens with prefilled cartridges or reusable cannula, while a few attach directly to today; the frequency has decreased over
insulin pens with replaceable insulin car- the skin, without tubing. the past decades and its causes have
tridges. Some reusable pens include a Most studies comparing multiple daily changed (20,21). Current reasons for
memory function, which can recall dose injections (MDI) with CSII have been attrition are problems with cost, wear-
amounts and timing. “Smart” pens that relatively small and of short duration. ability, disliking the pump, suboptimal
can be programmed to calculate insulin However, a recent systematic review and glycemic control, or mood disorders (e.g.,
doses and provide downloadable data meta-analysis concluded that pump ther- anxiety or depression) (22).
reports are also available. Pens also apy has modest advantages for lower-
vary with respect to dosing increment ing A1C (–0.30% [95% CI 20.58 to 20.02]) Insulin Pumps in Pediatrics
and minimal dose, which can range from and for reducing severe hypoglycemia The safety of insulin pumps in youth has
half-unit doses to 2-unit dose increments. rates in children and adults (8). There is been established for over 15 years (23).
Needle thickness (gauge) and length is no consensus to guide choosing which Studying the effectiveness of CSII in low-
another consideration. Needle gauges form of insulin administration is best for a ering A1C has been challenging because
range from 22 to 33, with higher gauge given patient, and research to guide this of the potential selection bias of obser-
indicating a thinner needle. A thicker decision making is needed (9). Thus, the vational studies. Participants on CSII may
needle can give a dose of insulin more choice of MDI or an insulin pump is often have a higher socioeconomic status that
care.diabetesjournals.org Diabetes Technology S73

may facilitate better glycemic control provider, to ensure that data are used in an
postprandially, prior to exercise,
(24) versus MDI. In addition, the fast effective and timely manner. For patients
when they suspect low blood
pace of development of new insulins with type 1 diabetes using CGM, the great-
glucose, after treating low blood
and technologies quickly renders com- est predictor of A1C lowering for all age-
glucose until they are normogly-
parisons obsolete. However, randomized groups was frequency of sensor use, which
cemic, and prior to critical tasks
controlled trials (RCTs) comparing CSII was highest in those aged $25 years and
such as driving. B
and MDI with insulin analogs demon- lower in younger age-groups (41). Simi-
7.7 When prescribed as part of a
strate a modest improvement in A1C in larly, for SMBG in patients with type 1
broad educational program, self-
participants on CSII (25,26). Observational diabetes, there is a correlation between
monitoring of blood glucose may
studies, registry data, and meta-analysis greater SMBG frequency and lower A1C
help to guide treatment decisions
have also suggested an improvement of (42). Among patients who check their
and/or self-management for pa-
glycemic control in participants on CSII blood glucose at least once daily, many
tients taking less frequent insu-
(27–29). Although hypoglycemia was a report taking no action when results are
lin injections. B
major adverse effect of intensified insu- high or low (43). Patients should be taught
7.8 When prescribing self-monitoring
lin regimen in the Diabetes Control and how to use SMBG and/or CGM data to
of blood glucose, ensure that pa-
Complications Trial (DCCT) (30), data sug- adjust food intake, exercise, or pharma-
tients receive ongoing instruction
gests that CSII may reduce the rates of cologic therapy to achieve specific goals.
and regular evaluation of tech-
severe hypoglycemia compared with MDI The ongoing need for and frequency of
nique, results, and their ability to
(29,31–33). There is also evidence that SMBG should be reevaluated at each
use data from self-monitoring
CSII may reduce DKA risk (29,34) and routine visit to avoid overuse, particularly
of blood glucose to adjust ther-
diabetes complications, in particular, ret- if SMBG is not being used effectively for
apy. Similarly, continuous glu-
inopathy and peripheral neuropathy in self-management (43–45).
cose monitoring use requires
youth, compared with MDI (35). Finally,
robust and ongoing diabetes ed- For Patients on Intensive Insulin
treatment satisfaction and quality-of-life
ucation, training, and support. E Regimens
measures improved on CSII compared
SMBG or CGM is especially important for
with MDI (36,37). Therefore, CSII can
Major clinical trials of insulin-treated insulin-treated patients to monitor for
be used safely and effectively in youth
patients have included self-monitoring of and prevent hypoglycemia and hypergly-
with type 1 diabetes to assist with achiev-
blood glucose (SMBG) as part of multifac- cemia. Most patients using intensive in-
ing targeted glycemic control while re-
torial interventions to demonstrate the sulin regimens (MDI or insulin pump
ducing the risk of hypoglycemia and DKA,
benefit of intensive glycemic control on therapy) should assess glucose levels using
improving quality of life and prevent-
diabetes complications (40). SMBG is thus SMBG or a CGM prior to meals and snacks,
ing long-term complications. Based on
an integral component of effective therapy at bedtime, occasionally postprandially,
patient-provider shared decision making,
of patients taking insulin. In recent years, prior to exercise, when they suspect low
insulin pumps may be considered in all
continuous glucose monitoring (CGM) has blood glucose, after treating low blood
pediatric patients. In particular, pump
emerged as a complementary method for glucose until they are normoglycemic, and
therapy may be the preferred mode of
the assessment of glucose levels (discussed prior to critical tasks such as driving. For
insulin delivery for children under 7 years
below). Glucose monitoring allows patients many patients using SMBG, this will require
of age (38). Because of a paucity of data in
to evaluate their individual response to testing up to 6–10 times daily, although
adolescents and youths with Type 2 di-
therapy and assess whether glycemic tar- individual needs may vary. A database
abetes, there is insufficient evidence to
gets are being safely achieved. Integrating study of almost 27,000 children and ado-
make recommendations.
results into diabetes management can be lescents with type 1 diabetes showed that,
Common barriers to pump therapy
a useful tool for guiding medical nutrition after adjustment for multiple confounders,
adoption in children and adolescents are
therapy and physical activity, preventing increased daily frequency of SMBG was
concerns regarding the physical interfer-
hypoglycemia, and adjusting medications significantly associated with lower A1C
ence of the device, discomfort with idea of
(particularly prandial insulin doses). The (–0.2% per additional test per day) and
having a device on the body therapeutic
patient’s specific needs and goals should with fewer acute complications (46).
effectiveness, and financial burden (27,39).
dictate SMBG frequency and timing or
For Patients Using Basal Insulin and/or
the consideration of CGM use.
SELF-MONITORING OF BLOOD Oral Agents
GLUCOSE The evidence is insufficient regarding
Optimizing Self-monitoring of Blood when to prescribe SMBG and how often
Recommendations
Glucose and Continuous Glucose testing is needed for insulin-treated pa-
7.6 Most patients using intensive in-
Monitor Use tients who do not use intensive insulin
sulin regimens (multiple daily in-
SMBG and CGM accuracy is dependent on regimens, such as those with type 2 di-
jections or insulin pump therapy)
the instrument and user, so it is important abetes using basal insulin with or without
should assess glucose levels us-
to evaluate each patient’s monitoring tech- oral agents. However, for patients using
ing self-monitoring of blood
nique, both initially and at regular intervals basal insulin, assessing fasting glucose
glucose (or continuous glucose
thereafter. Optimal use of SMBG and CGM with SMBG to inform dose adjustments
monitoring) prior to meals and
requires proper review and interpretation to achieve blood glucose targets results in
snacks, at bedtime, occasionally
of the data, by both the patient and the lower A1C (47,48).
S74 Diabetes Technology Diabetes Care Volume 42, Supplement 1, January 2019

In people with type 2 diabetes not Oxygen. Currently available glucose mon-
with glucose meter accuracy and itors utilize an enzymatic reaction linked
using insulin, routine glucose monitoring
choose appropriate devices for to an electrochemical reaction, either
may be of limited additional clinical ben-
their patients based on these fac- glucose oxidase or glucose dehydroge-
efit. For some individuals, glucose moni-
tors. E nase (58). Glucose oxidase monitors are
toring can provide insight into the impact
of diet, physical activity, and medication sensitive to the oxygen available and
Glucose meters meeting U.S. Food and
management on glucose levels. Glucose should only be used with capillary blood
Drug Administration (FDA) guidance for
monitoring may also be useful in assessing in patients with normal oxygen saturation.
meter accuracy provide the most reliable
hypoglycemia, glucose levels during inter- Higher oxygen tensions (i.e., arterial blood
data for diabetes management. There
current illness, or discrepancies between or oxygen therapy) may result in false low-
are several current standards for accu-
measured A1C and glucose levels when glucose readings, and low oxygen tensions
racy of blood glucose monitors, but the
there is concern an A1C result may not (i.e., high altitude, hypoxia, or venous
two most used are those of the Inter-
be reliable in specific individuals. How- blood readings) may lead to false high-
national Organization for Standardiza-
ever, several randomized trials have called glucose readings. Glucose dehydrogenase
tion (ISO 15197:2013) and the FDA.
into question the clinical utility and monitors are not sensitive to oxygen.
The current ISO and FDA standards are
cost-effectiveness of routine SMBG in Temperature. Because the reaction is sen-
compared in Table 7.1. In Europe, currently
noninsulin-treated patients (49–52). In a sitive to temperature, all monitors have
marketed monitors must meet current ISO
year-long study of insulin-naive patients an acceptable temperature range (58).
standards. In the U.S., currently marketed
with suboptimal initial glycemic control, Most will show an error if the temper-
monitors must meet the standard under
a group trained in structured SMBG (a ature is unacceptable, but a few will
which they were approved, which may
paper tool was used at least quarterly to provide a reading and a message indi-
not be the current standard. Moreover,
collect and interpret seven-point SMBG cating that the value may be incorrect.
the monitoring of current accuracy is left
profiles taken on 3 consecutive days) re-
to the manufacturer and not routinely Interfering Substances. There are a few
duced their A1C by 0.3% more than the
checked by an independent source. physiologic and pharmacologic factors
control group (53). A trial of once-daily
Patients assume their glucose monitor that interfere with glucose readings.
SMBG that included enhanced patient
is accurate because it is FDA cleared, Most interfere only with glucose oxidase
feedback through messaging found no
but often that is not the case. There is systems (58). They are listed in Table 7.2.
clinically or statistically significant change
substantial variation in the accuracy of
in A1C at 1 year (52). Meta-analyses have
widely used blood glucose monitor- CONTINUOUS GLUCOSE
suggested that SMBG can reduce A1C by
ing systems. The Diabetes Technol- MONITORS
0.25–0.3% at 6 months (54–56), but the
ogy Society Blood Glucose Monitoring
effect was attenuated at 12 months in one Recommendations
System Surveillance Program provides
analysis (54). Reductions in A1C were greater
information on the performance of 7.10 Sensor-augmented pump ther-
(20.3%) in trials where structured SMBG apy may be considered for chil-
devices used for SMBG (https://www
data were used to adjust medications but dren, adolescents, and adults to
.diabetestechnology.org/surveillance
not significant without such structured di- improve glycemic control with-
.shtml). In a recent analysis, the program
abetes therapy adjustment (56). A key con- out an increase in hypoglycemia
found that only 6 of the top 18 glucose
sideration is that performing SMBG alone or severe hypoglycemia. Bene-
meters met the accuracy standard
does not lower blood glucose levels. To be
(57). fits correlate with adherence to
useful, the information must be integrated ongoing use of the device. A
into clinical and self-management plans. 7.11 When prescribing continuous
Factors Limiting Accuracy
glucose monitoring, robust di-
Glucose Meter Accuracy Counterfeit Strips. Patients
should be ad-
abetes education, training, and
vised against purchasing or reselling
Recommendation support are required for opti-
preowned or second-hand test strips,
7.9 Health care providers should be mal continuous glucose moni-
as these may give incorrect results.
aware of the medications and tor implementation and ongoing
Only unopened vials of glucose test strips
other factors that can interfere use. E
should be used to ensure SMBG accuracy.

Table 7.1—Comparison of ISO 15197 and FDA blood glucose meter accuracy standards
Setting FDA125,126 ISO 15197-2013127
Home use 95% within 15% for all BG in the usable BG range†
99% within 20% for all BG in the usable BG range†
95% within 15% for BG $100 mg/dL
Hospital use 95% within 12% for BG $75 mg/dL
95% within 15 mg/dL for BG ,100 mg/dL
95% within 12 mg/dL for BG ,75 mg/dL
99% in A or B region of Consensus Error Grid‡
98% within 15% for BG $75 mg/dL
98% within 15 mg/dL for BG ,75 mg/dL
BG, blood glucose. To convert mg/dL to mmol/L, see http://www.endmemo.com/medical/unitconvert/Glucose.php. †The range of BG values for which
the meter has been proven accurate and will provide readings (other than low, high, or error). ‡Values outside of the “clinically acceptable” A and B
regions are considered “outlier” readings and may be dangerous to use for therapeutic decisions128.
care.diabetesjournals.org Diabetes Technology S75

Table 7.2—Interfering substances (62). To make these metrics more action- provided data on real-time CGM use
Glucose oxidase monitors able, standardized reports with visual in the youngest age groups (68–70).
Uric acid cues, such as an ambulatory glucose Finally, while limited by the observa-
Galactose profile (62), may help the patient and the tional nature, registry data provide
Xylose provider interpret the data and use it to some evidence of real-world use of
Acetaminophen guide treatment decisions. the technologies (71,72).
L-dopa
Ascorbic acid
In addition, while A1C is well estab-
lished as an important risk marker for Impact on Glycemic Control
Glucose dehydrogenase monitors
Icodextrin (used in peritoneal dialysis) diabetes complications, with the increas- When data from adult and pediatric
ing use of CGM to help facilitate safe participants is analyzed together, CGM
and effective diabetes management, it is use in RCTs has been associated with
important to understand how CGM met- reduction in A1C levels (64–66). Yet, in
7.12 People who have been success-
rics, such as mean glucose and A1C corre- the JDRF CGM trial, when youth were
fully using continuous glucose
late. Estimated A1C (eA1C) is a measure analyzed by age-group (8- to 14-year-
monitors should have contin-
converting the mean glucose from CGM or olds and 15- to 24-year-olds), no change
ued access across third-party
self-monitored blood glucose readings, us- in A1C was seen, likely due to poor CGM
payers. E
ing a formula derived from glucose read- adherence (41). Indeed, in a secondary
ings from a population of individuals, analysis of that RCT’s data in both pedi-
CGM measures interstitial glucose (which into an estimate of a simultaneously atric cohorts, those who utilized the
correlates well with plasma glucose). measured laboratory A1C. Recently, the sensor $6 days/week had an improve-
There are two types of CGM devices. eA1C was renamed the glucose manage- ment in their glycemic control (73).
Most CGM devices are real-time CGM, ment indicator (GMI), and a new formula One critical component to success with
which continuously report glucose lev- was generated for converting CGM- CGM is near-daily wearing of the device
els and include alarms for hypoglyce- derived mean glucose to GMI based on (64,74–76).
mic and hyperglycemic excursions. The recent clinical trials using the most ac- Though data from small observational
other type of device is intermittently curate CGM systems available. This pro- studies demonstrate that CGM can be
scanning CGM (isCGM), which is ap- vided a new way to use CGM data to worn by patients ,8 years old and the
proved for adult use only. isCGM, dis- estimate A1C (63). use of CGM provides insight to glycemic
cussed more fully below, does not have patterns (68,69), an RCT in children aged
alarms and does not communicate con- 4 to 9 years did not demonstrate im-
Real-time Continuous Glucose
tinuously, only on demand. It is reported provements in glycemic control following
Monitor Use in Youth
to have a lower cost than systems with 6 months of CGM use (67). However, ob-
automatic alerts. Recommendation servational feasibility studies of toddlers
For some CGM systems, SMBG is re- 7.13 Real-time continuous glucose demonstrated a high degree of parental
quired to make treatment decisions, al- monitoring should be consid- satisfaction and sustained use of the de-
though a randomized controlled trial of ered in children and adolescents vices despite the inability to change the
226 adults suggested that an enhanced with type 1 diabetes, whether degree of glycemic control attained (70).
CGM device could be used safely and using multiple daily injections or Registry data has also shown an asso-
effectively without regular confirmatory continuous subcutaneous insu- ciation between CGM use and lower A1C
SMBG in patients with well-controlled lin infusion, as an additional tool levels (71,72), even when limiting as-
type 1 diabetes at low risk of severe to help improve glucose control sessment of CGM use to participants
hypoglycemia (59). Two CGM devices are and reduce the risk of hypogly- on injection therapy (72).
now approved by the FDA for making cemia. Benefits of continuous
treatment decisions without SMBG con- glucose monitoring correlate with Impact on Hypoglycemia
firmation, sometimes called adjunctive adherence to ongoing use of the Apart from the Sensing With Insu-
use (60,61). device. B lin pump Therapy to Control HbA 1c
The abundance of data provided by (SWITCH) study, which showed a signif-
CGM offers opportunities to analyze Data regarding use of real-time CGM icant effect of adding CGM to insulin
patient data more granularly than was in youth consist of findings from RCTs pump therapy on time spent in hypogly-
previously possible, providing additional and small observational studies, as cemia (64), most studies focusing on
information to aid in achieving glycemic well as analysis of data collected by glycemic management overall failed to
targets. A variety of metrics have been registries. Some of the RCTs have in- demonstrate a significant or relevant re-
proposed (62). As recently reported, the cluded both adult and pediatric partic- duction in level 1 hypoglycemia (41,65–
metrics may include: 1) average glucose; 2) ipants (41,64–66), while others have 67,77). Notably, RCTs primarily aimed at
percentage of time in hypoglycemic only included pediatric participants hypoglycemia prevention did demon-
ranges, i.e., ,54 mg/dL (level 2), 54–70 (67) or limited the analysis of larger strate a significant reduction in mild hy-
mg/dL (level 1) (62); 3) percentage of studies to just the pediatric participants poglycemia in terms of reducing the time
time in target range, i.e., 70–180 mg/dL (41). Given the feasibility problems of spent in hypoglycemia by approximately
(3.9–9.9 mmol/L); 4) percentage of time performing RCTs in very young children, 40% and reducing the number of level 1
in hyperglycemic range, i.e., $180 mg/dL small observational studies have also hypoglycemia events per day (78,79).
S76 Diabetes Technology Diabetes Care Volume 42, Supplement 1, January 2019

Real-time Continuous Glucose Primary Outcome: A1C Reduction predicted to go low within the next
Monitor Use in Adults In general, A1C reduction was shown in 30 min have been approved by the FDA.
studies where the baseline A1C was The Automation to Simulate Pancreatic
Recommendations
higher. In two larger studies in adults Insulin Response (ASPIRE) trial of 247
7.14 When used properly, real-time
with type 1 diabetes that assessed the patients with type 1 diabetes and doc-
continuous glucose monitoring
benefit of CGM in patients on MDI, umented nocturnal hypoglycemia showed
in conjunction with intensive
there were significant reductions in that sensor-augmented insulin pump
insulin regimens is a useful
A1C: 20.6% in one (80,81) and 20.43% therapy with a low-glucose suspend func-
tool to lower A1C in adults
in the other (82). No reduction in A1C tion significantly reduced nocturnal
with type 1 diabetes who are
was seen in a small study performed in hypoglycemia over 3 months without
not meeting glycemic targets. A
underserved, less well-educated adults increasing A1C levels (66). In a different
7.15 Real-time continuous glucose
with type 1 diabetes (83). In the adult sensor-augmented pump, predictive low-
monitoring may be a useful tool
subset of the JDRF CGM study, there was glucose suspend reduced time spent
in those with hypoglycemia un-
a significant reduction in A1C of 20.53% with glucose ,70 mg/dL from 3.6%
awareness and/or frequent hy-
(71) in patients who were primarily at baseline to 2.6% (3.2% with sensor-
poglycemic episodes. B
treated with insulin pump therapy. Better augmented pump therapy without pre-
7.16 Real-time continuous glucose
adherence in wearing the CGM device dictive low glucose suspend) without
monitoring should be used as
resulted in a greater likelihood of an im- rebound hyperglycemia during a 6-
close to daily as possible for
provement in glycemic control (41,84). week randomized crossover trial (95a).
maximal benefit. A
Studies in people with type 2 diabetes These devices may offer the opportunity
7.17 Real-time continuous glucose
are heterogeneous in designdin two, to reduce hypoglycemia for those with a
monitoring may be used ef-
participants were using basal insulin history of nocturnal hypoglycemia.
fectively to improve A1C lev-
with oral agents or oral agents alone
els and neonatal outcomes in Real-time Continuous Glucose
(65,95); in one, individuals were on
pregnant women with type 1 Monitor Use in Pregnancy
MDI alone (92); and in another, par-
diabetes. B One well-designed RCT showed a reduc-
ticipants were on CSII or MDI (79). The
7.18 Sensor-augmented pump ther-
findings in studies with MDI alone (92) tion in A1C levels in adult women with
apy with automatic low-glucose type 1 diabetes on MDI or CSII who were
and in two studies in people using oral
suspend may be considered pregnant (96). Neonatal outcomes were
agents with or without insulin (93,95)
for adults with type 1 diabetes better when the mother used CGM
showed significant reductions in A1C
at high risk of hypoglycemia during pregnancy (80). Two studies em-
levels.
to prevent episodes of hypo- ploying intermittent use of real-time
glycemia and reduce their se- CGM showed no difference in neonatal
Primary Outcome: Hypoglycemia
verity. B outcomes in women with type 1 diabe-
In studies in adults where reduction in
episodes of hypoglycemia was the pri- tes (97) or gestational diabetes mellitus
Data exist to support the use of CGM mary end point, significant reductions (98).
in adults, both those on MDI and on were seen in individuals with type 1
Intermittently Scanned Continuous
CSII. In terms of randomized controlled diabetes on MDI or CSII (85–87). In
Glucose Monitor Use
trials in people with type 1 diabetes, one study in patients who were at
there are four studies in adults with higher risk for episodes of hypoglyce- Recommendation
A1C as the primary outcome (80–84), mia (87), there was a reduction in rates 7.19 Intermittently scanned contin-
three studies in adults with hypogly- of all levels of hypoglycemia (see Sec- uous glucose monitor use may
cemia as the primary outcome (85–87), tion 6 “Glycemic Targets” for hypogly- be considered as a substitute
four studies in adults and children cemia definitions). The Multiple Daily for self-monitoring of blood
with A1C as the primary outcome Injections and Continuous Glucose Mon- glucose in adults with diabetes
(41,64–66), and three studies in adults itoring in Diabetes (DIAMOND) study in requiring frequent glucose test-
and children with hypoglycemia as a people with type 2 diabetes on MDI did ing. C
primary outcome (41,78,88). There are not show a reduction in hypoglycemia
three studies in adults with type 1 or (92). Studies in individuals with type 2 isCGM (sometimes referred to as “flash”
type 2 diabetes (89–91) and four studies diabetes on oral agents with or without CGM) is a CGM that measures glucose
with adults with type 2 diabetes (92–95). insulin did not show reductions in rates in interstitial fluid through a ,0.4 mm–
Finally, there are three studies that have of hypoglycemia (93,95). CGM may be thick filament that is inserted under the
been done in pregnant women with particularly useful in insulin-treated pa- skin. It has been available in Europe
prepregnancy diabetes or gestational tients with hypoglycemia unawareness since 2014 and was approved by the
diabetes mellitus (96–98). Overall, ex- and/or frequent hypoglycemic episodes, FDA for use in adults in the U.S. in 2017.
cluding studies evaluating pediatric pa- although studies have not shown consis- The personal version of isCGM has a re-
tients alone or pregnant women, 2,984 tent reductions in severe hypoglycemia ceiver that, after scanning over the sensor
people with type 1 or type 2 diabetes (41,64,65). by the individual, displays real-time glu-
have been studied to assess the benefits Sensor-augmented pumps that sus- cose values and glucose trend arrows.
of CGM. pend insulin when glucose is low or The data can be uploaded and a report
care.diabetesjournals.org Diabetes Technology S77

created using available software. In the and safety for individuals with type 1 124) demonstrated safety (122) and
professional version, the patient does and type 2 diabetes, based on data improved A1C in adults (reduction from
not carry a receiver; the data are blinded available until January 2017 (114). The 7.3 6 0.9% to 6.8 6 0.6%) and adolescents
to the patient and the device is down- authors concluded that, although there (7.7 6 0.8% to 7.1 6 0.6%) (123).
loaded in the diabetes care provider’s were few quality data available at the time To date, the longest outpatient RCTs
office using the provider’s receiver and of the report, isCGM may increase treat- lasted 12 weeks and compared HCL
the software. The isCGM sensor is smaller ment satisfaction, increase time in range, treatment (a system that is not currently
than those of other systems and is wa- and reduce frequency of nocturnal hypo- FDA approved) to sensor-augmented
ter resistant. In the U.S., the FDA now glycemia, without differences in A1C or pumps in adults and children as young
requires a 1-h start-up time after activation quality of life or serious adverse events. as 6 years of age (n 5 86) with A1C levels
of the system, and it can be worn up to The Canadian Agency for Drugs and above target at baseline. Compared with
14 days. The isCGM does not require Technologies in Health reviewed existing sensor-augmented pump therapy, the
calibration with SMBG because it is fac- data on isCGM performance and accu- HCL system reduced the risk for hypogly-
tory calibrated. Acetaminophen does racy, hypoglycemia, effect on A1C, and cemia and improved glucose control in
not cause interference with glucose patient satisfaction and quality of life A1C levels (124).
readings. The mean absolute relative and concluded that the system could
difference reported by the manufac- replace SMBG in particular in patients
turer is 9.4%. It measures glucose every who require frequent testing (115). The Future Systems
minute, records measurements every last review published at the time of this A multitude of other automated insulin
15 min, and displays up to 8 h of data. report (116) also supported the use of delivery systems are currently being in-
As opposed to real-time CGM systems, isCGM as a more affordable alternative vestigated, including those with dual
isCGM has no alarms. The direct costs to real-time CGM systems for individ- hormones (insulin and glucagon or insulin
of isCGM are lower than those of real- uals with diabetes who are on intensive and pramlintide). Furthermore, some
time CGM systems. In general, both insulin therapy. patients have created do-it-yourself
the consumer and professional versions systems through guidance from online
are covered by most commercial in- communities, although these are not FDA
AUTOMATED INSULIN DELIVERY approved or recommended.
surance carriers and eligible Medicare
programs. Information on Medicaid cov- Recommendation
References
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Diabetes Care Volume 42, Supplement 1, January 2019 S81

8. Obesity Management for the American Diabetes Association

Treatment of Type 2 Diabetes:


Standards of Medical Care in
Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S81–S89 | https://doi.org/10.2337/dc19-S008

8. OBESITY MANAGEMENT FOR THE TREATMENT OF TYPE 2 DIABETES


The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”
includes ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee, are responsible for updating the Standards of
Care annually, or more frequently as warranted. For a detailed description of ADA
standards, statements, and reports, as well as the evidence-grading system for
ADA’s clinical practice recommendations, please refer to the Standards of Care
Introduction. Readers who wish to comment on the Standards of Care are invited
to do so at professional.diabetes.org/SOC.

There is strong and consistent evidence that obesity management can delay the
progression from prediabetes to type 2 diabetes (1–5) and is beneficial in the
treatment of type 2 diabetes (6–17). In patients with type 2 diabetes who are
overweight or obese, modest and sustained weight loss has been shown to improve
glycemic control and to reduce the need for glucose-lowering medications (6–8). Small
studies have demonstrated that in patients with type 2 diabetes and obesity, more
extreme dietary energy restriction with very low-calorie diets can reduce A1C
to ,6.5% (48 mmol/mol) and fasting glucose to ,126 mg/dL (7.0 mmol/L) in
the absence of pharmacologic therapy or ongoing procedures (10,18,19). Weight loss–
induced improvements in glycemia are most likely to occur early in the natural history
of type 2 diabetes when obesity-associated insulin resistance has caused reversible
b-cell dysfunction but insulin secretory capacity remains relatively preserved
(8,11,19,20). The goal of this section is to provide evidence-based recommendations
for weight-loss therapy, including diet, behavioral, pharmacologic, and surgical
interventions, for obesity management as treatment for hyperglycemia in type 2
diabetes.

Suggested citation: American Diabetes Associa-


ASSESSMENT tion. 8. Obesity management for the treatment
of type 2 diabetes: Standards of Medical Care in
Recommendation Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):
8.1 At each patient encounter, BMI should be calculated and documented in the S81–S89
medical record. B © 2018 by the American Diabetes Association.
Readers may use this article as long as the work
is properly cited, the use is educational and not
At each routine patient encounter, BMI should be calculated as weight divided by for profit, and the work is not altered. More infor-
height squared (kg/m2) (21). BMI should be classified to determine the presence of mation is available at http://www.diabetesjournals
overweight or obesity, discussed with the patient, and documented in the patient .org/content/license.
S82 Obesity Management for the Treatment of Type 2 Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

record. In Asian Americans, the BMI reduced cardiovascular events in adults


should provide at least monthly
cutoff points to define overweight and with type 2 diabetes who were over-
contact and encourage ongo-
obesity are lower than in other popula- weight or obese (26), it did show the
ing monitoring of body weight
tions (Table 8.1) (22,23). Providers feasibility of achieving and maintaining
(weekly or more frequently)
should advise patients who are over- long-term weight loss in patients with
and/or other self-monitoring
weight or obese that, in general, higher type 2 diabetes. In the Look AHEAD
strategies, such as tracking in-
BMIs increase the risk of cardiovascular intensive lifestyle intervention group,
take, steps, etc.; continued con-
disease and all-cause mortality. Pro- mean weight loss was 4.7% at 8 years
sumption of a reduced-calorie
viders should assess each patient’s read- (27). Approximately 50% of intensive
diet; and participation in high
iness to achieve weight loss and jointly lifestyle intervention participants lost
levels of physical activity (200–
determine weight-loss goals and inter- and maintained $5% and 27% lost
300 min/week). A
vention strategies. Strategies may in- and maintained $10% of their initial
8.6 To achieve weight loss of .5%,
clude diet, physical activity, behavioral body weight at 8 years (27). Participants
short-term (3-month) interven-
therapy, pharmacologic therapy, and randomly assigned to the intensive life-
tions that use very low-calorie
metabolic surgery (Table 8.1). The latter style group achieved equivalent risk fac-
diets (#800 kcal/day) and total
two strategies may be prescribed for tor control but required fewer glucose-,
meal replacements may be pre-
carefully selected patients as adjuncts blood pressure–, and lipid-lowering
scribed for carefully selected pa-
to diet, physical activity, and behavioral medications than those randomly as-
tients by trained practitioners in
therapy. signed to standard care. Secondary anal-
medical care settings with close
yses of the Look AHEAD trial and other
medical monitoring. To main-
DIET, PHYSICAL ACTIVITY, AND large cardiovascular outcome studies
tain weight loss, such programs
BEHAVIORAL THERAPY document other benefits of weight
must incorporate long-term com-
loss in patients with type 2 diabetes,
Recommendations prehensive weight-maintenance
including improvements in mobility,
8.2 Diet, physical activity, and behav- counseling. B
physical and sexual function, and
ioral therapy designed to achieve
health-related quality of life (28). A
and maintain .5% weight loss Among patients with type 2 diabetes who
post hoc analysis of the Look AHEAD
should be prescribed for patients are overweight or obese and have inade-
study suggests that heterogeneous treat-
with type 2 diabetes who are quate glycemic, blood pressure, and lipid
ment effects may have been present.
overweight or obese and ready control and/or other obesity-related med-
Participants who had moderately or
to achieve weight loss. A ical conditions, lifestyle changes that re-
poorly controlled diabetes (A1C $6.8%
8.3 Such interventions should be sult in modest and sustained weight loss
[51 mmol/mol]) as well as both those
high intensity ($16 sessions in produce clinically meaningful reductions
with well-controlled diabetes (A1C
6 months) and focus on diet, in blood glucose, A1C, and triglycerides
,6.8% [51 mmol/mol]) and good self-
physical activity, and behavioral (6–8). Greater weight loss produces
reported health were found to have
strategies to achieve a 500–750 even greater benefits, including reduc-
significantly reduced cardiovascular
kcal/day energy deficit. A tions in blood pressure, improvements
events with intensive lifestyle interven-
8.4 Diets should be individualized, in LDL and HDL cholesterol, and reductions
tion during follow-up (29).
as those that provide the same in the need for medications to control
caloric restriction but differ in blood glucose, blood pressure, and lipids
(6–8,24), and may result in achievement of Lifestyle Interventions
protein, carbohydrate, and fat
glycemic goals in the absence of antihyper- Significant weight loss can be attained
content are equally effective in
with lifestyle programs that achieve a
achieving weight loss. A glycemia agent use in some patients (25).
500–750 kcal/day energy deficit, which
8.5 For patients who achieve short-
in most cases is approximately 1,200–
term weight-loss goals, long-term
Look AHEAD Trial 1,500 kcal/day for women and 1,500–
($1 year) comprehensive weight-
Although the Action for Health in Di- 1,800 kcal/day for men, adjusted for
maintenance programs should
abetes (Look AHEAD) trial did not show the individual’s baseline body weight.
be prescribed. Such programs
that an intensive lifestyle intervention Weight loss of 3–5% is the minimum

Table 8.1—Treatment options for overweight and obesity in type 2 diabetes


BMI category (kg/m2)
25.0–26.9 30.0–34.9 35.0–39.9
Treatment (or 23.0–26.9*) 27.0–29.9 (or 27.5–32.4*) (or 32.5–37.4*) $40 (or $ 37.5*)
Diet, physical activity, and behavioral therapy † † † † †
Pharmacotherapy † † † †
Metabolic surgery † † †
*Cutoff points for Asian American individuals. †Treatment may be indicated for selected motivated patients.
care.diabetesjournals.org Obesity Management for the Treatment of Type 2 Diabetes S83

necessary for any clinical benefit (21,30). intensive behavioral lifestyle interven- alternatives for medications that promote
However, weight-loss benefits are pro- tions unless a long-term comprehensive weight gain. Medications associated with
gressive; more intensive weight-loss weight-loss maintenance program is weight gain include antipsychotics (e.g.,
goals (.5%, .7%, .15%, etc.) may be provided (37,38). clozapine, olanzapine, risperidone, etc.)
pursued if needed to achieve a healthy and antidepressants (e.g., tricyclic antide-
weight and if they can be feasibly and PHARMACOTHERAPY pressants, selective serotonin reuptake
safely attained. inhibitors, and monoamine oxidase inhib-
Recommendations
These diets may differ in the types of itors), glucocorticoids, injectable proges-
8.7 When choosing glucose-lowering
foods they restrict (such as high-fat or tins, anticonvulsants including gabapentin,
medications for overweight or
high-carbohydrate foods) but are effec- and possibly sedating antihistamines and
obese patients with type 2 di-
tive if they create the necessary energy anticholinergics (40).
abetes, consider their effect
deficit (21,31–33). Use of meal replace-
on weight. E
ment plans prescribed by trained practi- Approved Weight-Loss Medications
8.8 Whenever possible, minimize
tioners, with close patient monitoring, The U.S. Food and Drug Administration
medications for comorbid con-
can be beneficial. Within the intensive (FDA) has approved medications for both
ditions that are associated with
lifestyle intervention group of the Look short-term and long-term weight man-
weight gain. E
AHEAD trial, for example, use of a agement as adjuncts to diet, exercise,
8.9 Weight-loss medications are
partial meal replacement plan was as- and behavioral therapy. Nearly all FDA-
effective as adjuncts to diet,
sociated with improvements in diet approved medications for weight loss
physical activity, and behavioral
quality (34). The diet choice should have been shown to improve glycemic
counseling for selected patients
be based on the patient’s health status control in patients with type 2 diabetes
with type 2 diabetes and BMI
and preferences. and delay progression to type 2 diabetes
$27 kg/m2. Potential benefits
Intensive behavioral lifestyle interven- in patients at risk (41). Phentermine is
must be weighed against the po-
tions should include $16 sessions in indicated as short-term (#12 weeks)
tential risks of the medications. A
6 months and focus on diet, physical treatment (42). Five weight-loss medi-
8.10 If a patient’s response to weight-
activity, and behavioral strategies to cations (or combination medications)
loss medications is ,5% weight
achieve an ;500–750 kcal/day energy are FDA-approved for long-term use
loss after 3 months or if there
deficit. Interventions should be provided (more than a few weeks) by patients
are significant safety or tolera-
by trained interventionists in either in-
bility issues at any time, the with BMI $27 kg/m2 with one or more
dividual or group sessions (30). obesity-associated comorbid conditions
medication should be discon-
Patients with type 2 diabetes who (e.g., type 2 diabetes, hypertension, and
tinued and alternative medica-
are overweight or obese and have lost dyslipidemia) who are motivated to lose
tions or treatment approaches
weight during the 6-month intensive weight (41). Medications approved by
should be considered. A
behavioral lifestyle intervention should the FDA for the treatment of obesity and
be enrolled in long-term ($1 year) com- their advantages and disadvantages are
prehensive weight-loss maintenance Antihyperglycemia Therapy summarized in Table 8.2. The rationale
programs that provide at least monthly Agents associated with varying degrees for weight-loss medications is to help
contact with a trained interventionist of weight loss include metformin, a- patients to more consistently adhere to
and focus on ongoing monitoring of glucosidase inhibitors, sodium–glucose low-calorie diets and to reinforce lifestyle
body weight (weekly or more fre- cotransporter 2 inhibitors, glucagon- changes. Providers should be knowledge-
quently) and/or other self-monitoring like peptide 1 receptor agonists, and able about the product label and should
strategies such as tracking intake, amylin mimetics. Dipeptidyl peptidase balance the potential benefits of success-
steps, etc.; continued consumption of 4 inhibitors are weight neutral. Unlike ful weight loss against the potential risks
a reduced-calorie diet; and participation in these agents, insulin secretagogues, thia- of the medication for each patient. These
highlevels ofphysical activity(200–300min/ zolidinediones, and insulin often cause medications are contraindicated in women
week (35). Some commercial and proprie- weight gain (see Section 9 “Pharmacologic who are pregnant or actively trying to
tary weight-loss programs have shown Approaches to Glycemic Treatment”). conceive. Women of reproductive po-
promising weight-loss results (36). A recent meta-analysis of 227 random- tential must be counseled regarding the
When provided by trained practi- ized controlled trials of antihyperglyce- use of reliable methods of contraception.
tioners in medical care settings with mia treatments in type 2 diabetes found
close medical monitoring, short-term that A1C changes were not associated Assessing Efficacy and Safety
(3-month) interventions that use very with baseline BMI, indicating that pa- Efficacy and safety should be assessed
low-calorie diets (defined as #800 tients with obesity can benefit from the at least monthly for the first 3 months
kcal/day) and total meal replacements same types of treatments for diabetes as of treatment. If a patient’s response is
may achieve greater short-term weight normal-weight patients (39). deemed insufficient (weight loss ,5%)
loss (10%–15%) than intensive behav- after 3 months or if there are significant
ioral lifestyle interventions that typically Concomitant Medications safety or tolerability issues at any time,
achieve 5% weight loss. However, weight Providers should carefully review the the medication should be discontinued
regain following the cessation of very patient’s concomitant medications and, and alternative medications or treat-
low-calorie diets is greater than following whenever possible, minimize or provide ment approaches should be considered.
S84

Table 8.2—Medications approved by the FDA for the treatment of obesity


1-Year (52- or 56-week)
mean weight loss (% loss from
baseline)
Average wholesale National Average Drug Weight loss
Typical adult price (30-day Acquisition Cost (30-day (% loss from Common side effects Possible safety concerns/considerations
Medication name maintenance dose supply) (100) supply) (101) Treatment arm baseline) (102–107) (102–107)
Short-term treatment (£12 weeks)
Phentermine (108) 8–37.5 mg q.d.* $5–$56 $4 (37.5 mg dose) 15 mg q.d.† 6.1 Dry mouth, insomnia, c Risk of severe hypertension
(37.5 mg dose) 7.5 mg q.d.† 5.5 dizziness, irritability c Contraindicated for use in combination with
PBO 1.7 monoamine oxidase inhibitors
Long-term treatment (>12 weeks)
Lipase inhibitor
Orlistat (3) 60 mg t.i.d. (OTC) $41–$82 $42 120 mg t.i.d.‡ 9.6 Abdominal pain, flatulence, c Potential malabsorption of fat-soluble
120 mg t.i.d. (Rx) $748 $556 PBO 5.6 fecal urgency, back pain, vitamins (A, D, E, K) and of certain
headache medications (e.g., cyclosporine, thyroid
hormone, anticonvulsants, etc.)
Obesity Management for the Treatment of Type 2 Diabetes

c Rare cases of severe liver injury reported


c Cholelithiasis
c Nephrolithiasis

Selective serotonin (5-HT) 5-HT2C receptor agonist


Lorcaserin (14) 10 mg b.i.d. $318 $255 10 mg b.i.d. 4.5 Headache, nausea, dizziness, c Serotonin syndrome– and neuroleptic
Lorcaserin XR 20 mg q.d. $318 $254 PBO 1.5 fatigue, nasopharyngitis malignant syndrome–like reactions
theoretically possible when coadministered
with other serotonergic or
antidopaminergic agents
c Monitor for depression or suicidal thoughts
c Worsening hypertension
c Avoid in liver and renal failure

Sympathomimetic amine anorectic/antiepileptic combination


Phentermine/ 7.5 mg/46 mg $223 (7.5 mg/ $178 (7.5 mg/ 15 mg/92 mg q.d.| 9.8 Constipation, paresthesia, c Birth defects
topiramate q.d.§ 46 mg dose) 46 mg dose) 7.5 mg/46 mg q.d.| 7.8 insomnia, nasopharyngitis, c Cognitive impairment
ER (109) PBO 1.2 xerostomia c Acute angle-closure glaucoma

Opioid antagonist/antidepressant combination


Naltrexone/ 8 mg/90 mg, $334 $267 16 mg/ 5.0 Constipation, nausea, c Contraindicated in patients with
bupropion ER 2 tablets b.i.d. 180 mg b.i.d. headache, xerostomia, uncontrolled hypertension and/or seizure
(15) PBO 1.8 insomnia disorders
c Contraindicated for use with chronic opioid
therapy
c Acute angle-closure glaucoma
c Black box warning:
c Risk of suicidal behavior/ideation

Continued on p. S85
Diabetes Care Volume 42, Supplement 1, January 2019
care.diabetesjournals.org Obesity Management for the Treatment of Type 2 Diabetes S85

MEDICAL DEVICES FOR WEIGHT

safety and side effect information is provided; for a comprehensive discussion of safety considerations, please refer to the prescribing information for each agent. b.i.d., twice daily; ER, extended release;
MEN 2, multiple endocrine neoplasia syndrome type 2; MTC, medullary thyroid carcinoma; OTC, over the counter; PBO, placebo; q.d., daily; Rx, prescription; t.i.d, three times daily; XR, extended release.
LOSS

All medications are contraindicated in women who are or may become pregnant. Women of reproductive potential must be counseled regarding the use of reliable methods of contraception. Select
Several minimally invasive medical de-

c Contraindicated with personal or family

*Use lowest effective dose; maximum appropriate dose is 37.5 mg. †Duration of treatment was 28 weeks in a general obese adult population. ‡Enrolled participants had normal (79%) or impaired
Possible safety concerns/considerations
vices have been recently approved by the
FDA for short-term weight loss (43). It
remains to be seen how these are used

c Risk of thyroid C-cell tumors

(21%) glucose tolerance. §Maximum dose, depending on response, is 15 mg/92 mg q.d. |Approximately 68% of enrolled participants had type 2 diabetes or impaired glucose tolerance.
for obesity treatment. Given the high

history of MTC or MEN 2


cost, extremely limited insurance cover-

(102–107)
age, and paucity of data in people with

Black box warning:


?Acute pancreatitis
diabetes at this time, these are not
considered to be the standard of care
for obesity management in people with
type 2 diabetes.
c
c

METABOLIC SURGERY
Hypoglycemia, constipation,
Common side effects

Recommendations
nausea, headache,

8.11 Metabolic surgery should be


indigestion
(102–107)

recommended as an option to
treat type 2 diabetes in appro-
priate surgical candidates with
BMI $40 kg/m2 (BMI $37.5
kg/m2 in Asian Americans) and
in adults with BMI 35.0–39.9
(% loss from
Weight loss
mean weight loss (% loss from

kg/m2 (32.5–37.4 kg/m2 in Asian


baseline)
1-Year (52- or 56-week)

6.0
4.7
2.0

Americans) who do not achieve


durable weight loss and improve-
baseline)

ment in comorbidities (including


hyperglycemia) with reasonable
Treatment arm

3.0 mg q.d.
1.8 mg q.d.

nonsurgical methods. A
PBO

8.12 Metabolic surgery may be consid-


ered as an option for adults with
type 2 diabetes and BMI 30.0–
34.9 kg/m2 (27.5–32.4 kg/m2 in
Acquisition Cost (30-day
Average wholesale National Average Drug

Asian Americans) who do not


supply) (101)

achieve durable weight loss and


$1,154

improvement in comorbidities (in-


cluding hyperglycemia) with rea-
sonable nonsurgical methods. A
8.13 Metabolic surgery should be
performed in high-volume cen-
ters with multidisciplinary teams
price (30-day
supply) (100)

that understand and are expe-


$1,441

rienced in the management of


diabetes and gastrointestinal
surgery. C
8.14 Long-term lifestyle support and
Glucagon-like peptide 1 receptor agonist
maintenance dose

routine monitoring of micronu-


Typical adult

trient and nutritional status must


3 mg q.d.

be provided to patients after sur-


gery, according to guidelines for
postoperative management of
Table 8.2—Continued

metabolic surgery by national


Liraglutide (16)

and international professional


Medication name

societies. C
8.15 People presenting for metabolic
surgery should receive a com-
prehensive readiness and men-
tal health assessment. B
S86 Obesity Management for the Treatment of Type 2 Diabetes Diabetes Care Volume 42, Supplement 1, January 2019

1 to 5 years in 30%–63% of patients two decades, with continued refinement


8.16 People who undergo metabolic
with Roux-en-Y gastric bypass (RYGB), of minimally invasive approaches (lapa-
surgery should be evaluated to
which generally leads to greater degrees roscopic surgery), enhanced training and
assess the need for ongoing
and lengths of remission compared with credentialing, and involvement of mul-
mental health services to help
other bariatric surgeries (17,62). Available tidisciplinary teams. Mortality rates with
them adjust to medical and
data suggest an erosion of diabetes re- metabolic operations are typically 0.1%–
psychosocial changes after sur-
mission over time (63): 35%–50% or more 0.5%, similar to cholecystectomy or
gery. C
of patients who initially achieve remis- hysterectomy (79–83). Morbidity has
sion of diabetes eventually experience also dramatically declined with laparo-
Several gastrointestinal (GI) operations recurrence. However, the median dis- scopic approaches. Major complications
including partial gastrectomies and ease-free period among such individuals rates (e.g., venous thromboembo-
bariatric procedures (35) promote dra- following RYGB is 8.3 years (64,65). With lism, need for operative reintervention)
matic and durable weight loss and im- or without diabetes relapse, the majority are 2%–6%, with other minor compli-
provement of type 2 diabetes in many of patients who undergo surgery main- cations in up to 15% (79–88), which
patients. Given the magnitude and ra- tain substantial improvement of glyce- compare favorably with rates for other
pidity of the effect of GI surgery on mic control from baseline for at least commonly performed elective opera-
hyperglycemia and experimental evi- 5 (66,67) to 15 (45,46,65,68–70) years. tions (83). Empirical data suggest that
dence that rearrangements of GI anat- Exceedingly few presurgical predictors proficiency of the operating surgeon is an
omy similar to those in some metabolic of success have been identified, but important factor for determining mor-
procedures directly affect glucose ho- younger age, shorter duration of diabe- tality, complications, reoperations, and
meostasis (36), GI interventions have tes (e.g., ,8 years) (71), nonuse of insulin, readmissions (89).
been suggested as treatments for type maintenance of weight loss, and better Longer-term concerns include dump-
2 diabetes, and in that context they are glycemic control are consistently associ- ing syndrome (nausea, colic, and diar-
termed “metabolic surgery.” ated with higher rates of diabetes remis- rhea), vitamin and mineral deficiencies,
A substantial body of evidence has sion and/or lower risk of weight regain anemia, osteoporosis, and, rarely (90),
now been accumulated, including data (45,69,71,72). Greater baseline visceral severe hypoglycemia. Long-term nutri-
from numerous randomized controlled fat area may also help to predict better tional and micronutrient deficiencies
(nonblinded) clinical trials, demonstrat- postoperative outcomes, especially among and related complications occur with
ing that metabolic surgery achieves su- Asian American patients with type 2 di- variable frequency depending on the
perior glycemic control and reduction of abetes, who typically have more visceral type of procedure and require life-
cardiovascular risk factors in patients fat compared with Caucasians with di- long vitamin/nutritional supplementa-
with type 2 diabetes and obesity com- abetes of the same BMI (73). tion (91,92). Postprandial hypoglycemia
pared with various lifestyle/medical Beyond improving glycemia, meta- is most likely to occur with RYGB
interventions (17). Improvements in micro- bolic surgery has been shown to confer (92,93). The exact prevalence of symp-
vascular complications of diabetes, car- additional health benefits in randomized tomatic hypoglycemia is unknown. In
diovascular disease, and cancer have controlled trials, including substantial one study, it affected 11% of 450 pa-
been observed only in nonrandomized reductions in cardiovascular disease risk tients who had undergone RYGB or ver-
observational studies (44–53). Cohort factors (17), reductions in incidence of tical sleeve gastrectomy (90). Patients
studies attempting to match surgical microvascular disease (74), and enhance- who undergo metabolic surgery may
and nonsurgical subjects suggest that ments in quality of life (66,71,75). be at increased risk for substance use,
the procedure may reduce longer-term Although metabolic surgery has been including drug and alcohol use and cig-
mortality (45). shown to improve the metabolic profiles arette smoking. Additional potential risks
On the basis of this mounting evi- of patients with type 1 diabetes and of metabolic surgery that have been
dence, several organizations and govern- morbid obesity, establishing the role of described include worsening or new-
ment agencies have recommended metabolic surgery in such patients will onset depression and/or anxiety, need
expanding the indications for metabolic require larger and longer studies (76). for additional GI surgery, and suicidal
surgery to include patients with type 2 Metabolic surgery is more expensive ideation (94–97).
diabetes who do not achieve durable than nonsurgical management strate- People with diabetes presenting for
weight loss and improvement in comor- gies, but retrospective analyses and mod- metabolic surgery also have increased
bidities (including hyperglycemia) with eling studies suggest that metabolic rates of depression and other major
reasonable nonsurgical methods at BMIs surgery may be cost-effective or even psychiatric disorders (98). Candidates for
as low as 30 kg/m2 (27.5 kg/m2 for Asian cost-saving for patients with type 2 metabolic surgery with histories of alco-
Americans) (54–61). Please refer to diabetes. However, results are largely hol, tobacco, or substance abuse; sig-
“Metabolic Surgery in the Treatment dependent on assumptions about the nificant depression; suicidal ideation; or
Algorithm for Type 2 Diabetes: A Joint long-term effectiveness and safety of other mental health conditions should
Statement by International Diabetes Or- the procedures (77,78). therefore first be assessed by a mental
ganizations” for a thorough review (17). health professional with expertise in
Randomized controlled trials have Adverse Effects obesity management prior to consider-
documented diabetes remission during The safety of metabolic surgery has ation for surgery (99). Surgery should be
postoperative follow-up ranging from improved significantly over the past postponed in patients with alcohol or
care.diabetesjournals.org Obesity Management for the Treatment of Type 2 Diabetes S87

substance abuse disorders, significant phentermine and topiramate extended release. intervention: the Look AHEAD study. Obesity
depression, suicidal ideation, or other Diabetes Care 2014;37:3309–3316 (Silver Spring) 2014;22:5–13
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S90 Diabetes Care Volume 42, Supplement 1, January 2019

9. Pharmacologic Approaches to American Diabetes Association

Glycemic Treatment: Standards of


Medical Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S90–S102 | https://doi.org/10.2337/dc19-S009
9. PHARMACOLOGIC APPROACHES TO GLYCEMIC TREATMENT

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”


includes ADA’s current clinical practice recommendations and is intended to provide
the components of diabetes care, general treatment goals and guidelines, and tools
to evaluate quality of care. Members of the ADA Professional Practice Committee, a
multidisciplinary expert committee, are responsible for updating the Standards of
Care annually, or more frequently as warranted. For a detailed description of ADA
standards, statements, and reports, as well as the evidence-grading system for
ADA’s clinical practice recommendations, please refer to the Standards of Care
Introduction. Readers who wish to comment on the Standards of Care are invited to
do so at professional.diabetes.org/SOC.

PHARMACOLOGIC THERAPY FOR TYPE 1 DIABETES


Recommendations
9.1 Most people with type 1 diabetes should be treated with multiple daily
injections of prandial and basal insulin, or continuous subcutaneous insulin
infusion. A