TH E JOU RNAL OF CLI N ICAL AN D APPLI ED RESEARCH AN D EDUCATION
`
`VOLUME 39 | SUPPLEMENT 1
`
`WWW.DIABETES.ORG/DIABETESCARE
`
`JANUARY 2016
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`L EM
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`T1
`
`EN
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`P
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`U P
`S
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`A M E R I C A N D I A B E T E S A S S O C I A T I O N
`
`STANDARDS OF
`MEDICAL CARE
`IN DIABETES—2016
`
`ISSN 0149-5992
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`Page 1 of 119
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`AstraZeneca Exhibit 2065
`Mylan v. AstraZeneca
`IPR2015-01340
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`

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`American Diabetes Association
`Standards of
`Medical Care in
`Diabetesd2016
`
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`January 2016 Volume 39, 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
`
`William T. Cefalu, MD
`
`ASSOCIATE EDITORS
`
`EDITORIAL BOARD
`
`George Bakris, MD
`Lawrence Blonde, MD, FACP
`Andrew J.M. Boulton, MD
`David D’Alessio, MD
`Sherita Hill Golden, MD, MHS, FAHA
`Mary de Groot, PhD
`Eddie L. Greene, MD
`Frank B. Hu, MD, MPH, PhD
`Derek LeRoith, MD, PhD
`Robert G. Moses, MD
`Stephen Rich, PhD
`Matthew C. Riddle, MD
`Julio Rosenstock, MD
`William V. Tamborlane, MD
`Katie Weinger, EdD, RN
`Judith Wylie-Rosett, EdD, RD
`
`Nicola Abate, MD
`Silva Arslanian, MD
`Angelo Avogaro, MD, PhD
`Ananda Basu, MD, FRCP
`John B. Buse, MD, PhD
`Sonia Caprio, MD
`Robert Chilton, DO
`Kenneth Cusi, MD, FACP, FACE
`Paresh Dandona, MD, PhD
`Stefano Del Prato, MD
`Dariush Elahi, PhD
`Franco Folli, MD, PhD
`Robert G. Frykberg, DPM, MPH
`W. Timothy Garvey, MD
`Ronald B. Goldberg, MD
`Margaret Grey, DrPH, RN, FAAN
`Richard Hellman, MD
`
`Rita Rastogi Kalyani, MD, MHS, FACP
`Rory J. McCrimmon, MBChB, MD, FRCP
`Harold David McIntyre, MD, FRACP
`Gianluca Perseghin, MD
`Anne L. Peters, MD
`Jonathan Q. Purnell, MD
`Peter Reaven, MD
`Helena Wachslicht Rodbard, MD
`David J. Schneider, MD
`Elizabeth R. Seaquist, MD
`Norbert Stefan, MD
`Jeff Unger, MD
`Ram Weiss, MD, PhD
`Deborah J. Wexler, MD, MSc
`Joseph Wolfsdorf, MD, BCh
`Tien Yin Wong, MBBS, FRCSE, FRANZCO,
`MPH, PhD
`
`AMERICAN DIABETES ASSOCIATION OFFICERS
`
`CHAIR OF THE BOARD
`Robin J. Richardson
`
`PRESIDENT, MEDICINE & SCIENCE
`Desmond Schatz, MD
`
`PRESIDENT, HEALTH CARE & EDUCATION
`Margaret A. Powers, PhD, RD, CDE
`
`SECRETARY/TREASURER
`Lorrie Welker Liang
`
`CHAIR OF THE BOARD-ELECT
`David A. DeMarco, PhD
`
`PRESIDENT-ELECT, MEDICINE & SCIENCE
`Alvin C. Powers, MD
`
`PRESIDENT-ELECT, HEALTH CARE &
`EDUCATION
`Brenda Montgomery, RN, MSHS, CDE
`
`SECRETARY/TREASURER-ELECT
`Umesh Verma
`
`CHIEF EXECUTIVE OFFICER
`Kevin L. Hagan
`
`CHIEF SCIENTIFIC & MEDICAL OFFICER
`Robert E. Ratner, MD, FACP, FACE
`
`The mission of the American Diabetes Association
`is to prevent and cure diabetes and to improve
`the lives of all people affected by diabetes.
`
`Page 4 of 119
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`

`
`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 © 2016 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,
`subscribing to the journal, becoming an ADA member, advertising, permission to reuse
`content, and the journal’s publication policies.
`
`PRINT ISSN 0149-5992
`ONLINE ISSN 1935-5548
`PRINTED IN THE USA
`
`AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS
`
`EDITORIAL OFFICE DIRECTOR
`Lyn Reynolds
`
`PEER REVIEW MANAGER
`Shannon Potts
`
`EDITORIAL OFFICE SECRETARIES
`Raquel Castillo
`Joan Garrett
`
`MANAGING DIRECTOR, SCHOLARLY
`JOURNAL PUBLISHING
`Christian S. Kohler
`
`DIRECTOR, SCHOLARLY JOURNAL PUBLISHING
`Heather Norton Blackburn
`
`EDITORIAL MANAGERS
`Valentina Such
`Nancy C. Baldino
`
`PRODUCTION MANAGER
`Amy S. Gavin
`
`TECHNICAL EDITOR
`Oedipa Rice
`
`MANAGING DIRECTOR, MEDIA SALES
`Clare Liberis
`cliberis@diabetes.org
`(212) 725-4925, ext. 3448
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`ADVERTISING MANAGER
`Julie DeVoss Graff
`jdevoss@diabetes.org
`(703) 299-5511
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`Laurie Ann Hall
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`Donald Crowl
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`Page 5 of 119
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`

`
`Standards of Medical Care in Diabetes—2016
`
`January 2016 Volume 39, Supplement 1
`
`S1
`S3
`S4
`
`S6
`
`S13
`
`S23
`
`S36
`
`S39
`
`S47
`
`S52
`
`Introduction
`Professional Practice Committee
`Standards of Medical Care in Diabetes—2016:
`Summary of Revisions
`1. Strategies for Improving Care
`
`Diabetes Care Concepts
`Care Delivery Systems
`When Treatment Goals Are Not Met
`Tailoring Treatment to Vulnerable Populations
`2. Classification and Diagnosis of Diabetes
`
`Classification
`Diagnostic Tests for Diabetes
`Categories of Increased Risk for Diabetes (Prediabetes)
`Type 1 Diabetes
`Type 2 Diabetes
`Gestational Diabetes Mellitus
`Monogenic Diabetes Syndromes
`Cystic Fibrosis–Related Diabetes
`3. Foundations of Care and Comprehensive Medical
`Evaluation
`
`Foundations of Care
`Basis for Initial Care
`Ongoing Care Management
`Diabetes Self-management Education and Support
`Medical Nutrition Therapy
`Physical Activity
`Smoking Cessation: Tobacco and e-Cigarettes
`Immunization
`Psychosocial Issues
`Comprehensive Medical Evaluation
`Comorbidities
`4. Prevention or Delay of Type 2 Diabetes
`
`Lifestyle Modification
`Pharmacological Interventions
`Diabetes Self-management Education and Support
`5. Glycemic Targets
`
`Assessment of Glycemic Control
`A1C Testing
`A1C Goals
`Hypoglycemia
`Intercurrent Illness
`6. Obesity Management for the Treatment of Type 2
`Diabetes
`
`Look AHEAD
`Assessment
`Diet, Physical Activity, and Behavioral Therapy
`Pharmacotherapy
`Bariatric Surgery
`7. Approaches to Glycemic Treatment
`
`Pharmacological Therapy for Type 1 Diabetes
`Pharmacological Therapy for Type 2 Diabetes
`Bariatric Surgery
`
`S60
`
`8. Cardiovascular Disease and Risk
`Management
`
`Hypertension/Blood Pressure Control
`Lipid Management
`Antiplatelet Agents
`Coronary Heart Disease
`
`S72
`
`9. Microvascular Complications and Foot Care
`
`Diabetic Kidney Disease
`Diabetic Retinopathy
`Neuropathy
`Foot Care
`
`S81
`
`10. Older Adults
`
`Overview
`Neurocognitive Function
`Hypoglycemia
`Treatment Goals
`Pharmacological Therapy
`Treatment in Skilled Nursing Facilities
`and Nursing Homes
`End-of-Life Care
`11. Children and Adolescents
`
`Type 1 Diabetes
`Type 2 Diabetes
`Transition From Pediatric to Adult Care
`12. Management of Diabetes in Pregnancy
`
`Diabetes in Pregnancy
`Preconception Counseling
`Glycemic Targets in Pregnancy
`Management of Gestational Diabetes Mellitus
`Management of Pregestational Type 1 Diabetes
`and Type 2 Diabetes in Pregnancy
`Postpartum Care
`Pregnancy and Antihypertensive Drugs
`13. Diabetes Care in the Hospital
`
`S86
`
`S94
`
`S99
`
`Hospital Care Delivery Standards
`Considerations on Admission
`Glycemic Targets in Hospitalized Patients
`Antihyperglycemic Agents in Hospitalized
`Patients
`Standards for Special Situations
`Treating and Preventing Hypoglycemia
`Self-management in the Hospital
`Medical Nutrition Therapy in the Hospital
`Transition From the Acute Care Setting
`Diabetes Care Providers in the Hospital
`Bedside Blood Glucose Monitoring
`S105 14. Diabetes Advocacy
`
`Advocacy Position Statements
`S107 Professional Practice Committee for the Standards
`of Medical Care in Diabetes—2016
`S109 Index
`
`This issue is freely accessible online at care.diabetesjournals.org.
`
`Keep up with the latest information for Diabetes Care and other ADA titles via Facebook (/ADAJournals) and Twitter (@ADA_Journals).
`
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`INTRODUCTION
`
`S1
`
`Diabetes Care Volume 39, Supplement 1, January 2016
`
`Introduction
`
`Diabetes Care 2016;39(Suppl. 1):S1–S2 | DOI: 10.2337/dc16-S001
`
`Diabetes is a complex, chronic illness re-
`quiring continuous medical care with
`multifactorial risk-reduction strategies
`beyond glycemic control. Ongoing patient
`self-management education and support
`are critical to preventing acute complica-
`tions and reducing the risk of long-term
`complications. Significant evidence exists
`that supports a range of interventions to
`improve diabetes outcomes.
`The American Diabetes Association’s
`(ADA’s) “Standards of Medical Care in
`Diabetes” is intended to provide clini-
`cians, patients, researchers, payers,
`and other interested individuals with
`the components of diabetes care, gen-
`eral treatment goals, and tools to eval-
`uate the quality of care. The Standards
`of Care recommendations are not in-
`tended to preclude clinical judgment
`and must be applied in the context of
`excellent clinical care, with adjustments
`for individual preferences, comorbid-
`ities, and other patient factors. For
`more detailed information about man-
`agement of diabetes, please refer to
`Medical Management of Type 1 Diabe-
`tes (1) and Medical Management of
`Type 2 Diabetes (2).
`include
`The recommendations
`screening, diagnostic, and therapeutic
`actions that are known or believed to
`favorably affect health outcomes of pa-
`tients with diabetes. Many of these in-
`terventions have also been shown to be
`cost-effective (3).
`The ADA strives to improve and up-
`date the Standards of Care to ensure
`that clinicians, health plans, and policy-
`makers can continue to rely on them as
`the most authoritative and current
`guidelines for diabetes care.
`
`ADA STANDARDS, STATEMENTS,
`AND REPORTS
`
`The ADA has been actively involved in
`the development and dissemination of
`
`diabetes care standards, guidelines, and
`related documents for over 25 years.
`ADA’s clinical practice recommenda-
`tions are viewed as important resources
`for health care professionals who care
`for people with diabetes. ADA’s “Stan-
`dards of Medical Care in Diabetes,”
`position statements, and scientific
`statements undergo a formal review
`process by ADA’s Professional Practice
`Committee (PPC) and the Executive
`Committee of the Board of Directors.
`The Standards and all ADA position
`statements, scientific statements, and
`consensus reports are available on the As-
`sociation’s Web site at http://professional
`.diabetes.org/adastatements.
`
`“Standards of Medical Care in
`Diabetes”
`Standards of Care: ADA position state-
`ment that provides key clinical practice
`recommendations. The PPC performs an
`extensive literature search and updates
`the Standards annually based on the
`quality of new evidence.
`
`ADA Position Statement
`A position statement is an official ADA
`point of view or belief that contains clin-
`ical or research recommendations. Posi-
`tion statements are issued on scientific
`or medical issues related to diabetes.
`They are published in the ADA journals
`and other scientific/medical publica-
`tions. ADA position statements are typ-
`ically based on a systematic review or
`other review of published literature.
`Position statements undergo a formal
`review process. They are updated every
`5 years or as needed.
`
`ADA Scientific Statement
`A scientific statement is an official ADA
`point of view or belief that may or may
`not contain clinical or research recom-
`mendations. Scientific statements con-
`tain scholarly synopsis of a topic related
`
`to diabetes. Workgroup reports fall into
`this category. Scientific statements are
`published in the ADA journals and other
`scientific/medical publications, as ap-
`propriate. Scientific statements also
`undergo a formal review process.
`
`Consensus Report
`A consensus report contains a compre-
`hensive examination by an expert panel
`(i.e., consensus panel) of a scientific or
`medical issue related to diabetes. A con-
`sensus report is not an ADA position and
`represents expert opinion only. The cat-
`egory may also include task force and
`expert committee reports. The need
`for a consensus report arises when clini-
`cians or scientists desire guidance on a
`subject for which the evidence is contra-
`dictory or incomplete. A consensus re-
`port is developed following a consensus
`conference where the controversial issue
`is extensively discussed. The report
`represents the panel’s collective anal-
`ysis, evaluation, and opinion at that
`point in time based in part on the con-
`ference proceedings. A consensus re-
`port does not undergo a formal ADA
`review process.
`
`GRADING OF SCIENTIFIC EVIDENCE
`
`Since the ADA first began publishing
`practice guidelines, there has been con-
`siderable evolution in the evaluation of
`scientific evidence and in the develop-
`ment of evidence-based guidelines. In
`2002, the ADA developed a classification
`system to grade the quality of scientific
`evidence supporting ADA recommenda-
`tions for all new and revised ADA posi-
`tion statements. A recent analysis of the
`evidence cited in the Standards of Care
`found steady improvement in quality
`over the past 10 years, with the 2014
`Standards for the first time having the
`majority of bulleted recommendations
`supported by A- or B-level evidence
`
`“Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: November 2015.
`
`© 2016 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.
`
`Page 8 of 119
`
`

`
`S2
`
`Introduction
`
`Diabetes Care Volume 39, Supplement 1, January 2016
`
`Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes”
`
`Level of
`evidence
`
`A
`
`B
`
`C
`
`E
`
`Description
`
`Clear evidence from well-conducted, generalizable randomized controlled trials
`that are adequately powered, including
`c Evidence from a well-conducted multicenter trial
`c Evidence from a meta-analysis that incorporated quality ratings in the
`analysis
`Compelling nonexperimental evidence, i.e., “all or none” rule developed by the
`Centre for Evidence-Based Medicine at the University of Oxford
`Supportive evidence from well-conducted randomized controlled trials that are
`adequately powered, including
`c Evidence from a well-conducted trial at one or more institutions
`c Evidence from a meta-analysis that incorporated quality ratings in the
`analysis
`Supportive evidence from well-conducted cohort studies
`c Evidence from a well-conducted prospective cohort study or registry
`c Evidence from a well-conducted meta-analysis of cohort studies
`Supportive evidence from a well-conducted case-control study
`Supportive evidence from poorly controlled or uncontrolled studies
`c Evidence from randomized clinical trials with one or more major or three or
`more minor methodological flaws that could invalidate the results
`c Evidence from observational studies with high potential for bias (such as
`case series with comparison with historical controls)
`c Evidence from case series or case reports
`Conflicting evidence with the weight of evidence supporting the
`recommendation
`Expert consensus or clinical experience
`
`(4). A grading system (Table 1) devel-
`oped by the ADA and modeled after ex-
`isting methods was used to clarify and
`codify the evidence that forms the basis
`for the recommendations. ADA recom-
`mendations are assigned ratings of A, B,
`or C, depending on the quality of evi-
`dence. Expert opinion E is a separate
`category for recommendations in which
`there is no evidence from clinical trials,
`
`in which clinical trials may be impracti-
`cal, or in which there is conflicting evi-
`dence. Recommendations with an A
`rating are based on large well-designed
`clinical trials or well-done meta-analyses.
`Generally, these recommendations
`have the best chance of improving out-
`comes when applied to the population
`to which they are appropriate. Recom-
`mendations with lower levels of evi-
`
`dence may be equally important but
`are not as well supported. Of course,
`evidence is only one component of clin-
`ical decision making. Clinicians care for
`patients, not populations; guidelines
`must always be interpreted with the in-
`dividual patient in mind. Individual cir-
`cumstances, such as comorbid and
`coexisting diseases, age, education, dis-
`ability, and, above all, patients’ values
`and preferences, must be considered
`and may lead to different treatment tar-
`gets and strategies. Furthermore, con-
`ventional evidence hierarchies, such as
`the one adapted by the ADA, may miss
`nuances important in diabetes care. For
`example, although there is excellent ev-
`idence from clinical trials supporting
`the importance of achieving multiple
`risk factor control, the optimal way to
`achieve this result is less clear. It is dif-
`ficult to assess each component of
`such a complex intervention.
`
`References
`1. American Diabetes Association. Medical
`Management of Type 1 Diabetes. 6th ed.
`Kaufman FR, Ed. Alexandria, VA, American Di-
`abetes Association, 2012
`2. American Diabetes Association. Medical
`Management of Type 2 Diabetes. 7th ed.
`Burant CF, Young LA, Eds. Alexandria, VA, Amer-
`ican Diabetes Association, 2012
`3. Li R, Zhang P, Barker LE, Chowdhury FM,
`Zhang X. Cost-effectiveness of interventions to
`prevent and control diabetes mellitus: a sys-
`tematic review. Diabetes Care 2010;33:1872–
`1894
`4. Grant RW, Kirkman MS. Trends in the evi-
`dence level for the American Diabetes Associa-
`tion’s “Standards of Medical Care in Diabetes”
`from 2005 to 2014. Diabetes Care 2015;38:6–8
`
`Page 9 of 119
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`

`
`PROFESSIONAL PRACTICE COMMITTEE
`
`Diabetes Care Volume 39, Supplement 1, January 2016
`
`S3
`
`Professional Practice Committee
`
`Diabetes Care 2016;39(Suppl. 1):S3 | DOI: 10.2337/dc16-S002
`
`The Professional Practice Committee
`(PPC) of the American Diabetes Associ-
`ation (ADA) is responsible for the “Stan-
`dards of Medical Care in Diabetes”
`position statement, referred to as the
`“Standards of Care.” The PPC is a multi-
`disciplinary expert committee com-
`prised of physicians, diabetes educators,
`registered dietitians, and others who
`have expertise in a range of areas, in-
`cluding adult and pediatric endocrinol-
`ogy, epidemiology, public health, lipid
`research, hypertension, preconception
`planning, and pregnancy care. Appoint-
`ment to the PPC is based on excellence
`in clinical practice and research. Al-
`though the primary role of the PPC is
`to review and update the Standards of
`Care, it is also responsible for oversee-
`ing the review and revisions of ADA’s
`position statements and scientific
`statements.
`The ADA adheres to the Institute of
`Medicine Standards for Developing
`Trustworthy Clinical Practice Guidelines.
`All members of the PPC are required to
`disclose potential conflicts of interest
`with industry and/or other relevant or-
`ganizations. These disclosures are dis-
`cussed at the onset of each Standards
`of Care revision meeting. Members of the
`committee, their employer, and their dis-
`closed conflicts of interest are listed in
`the “Professional Practice Committee
`for the Standards of Medical Care in
`Diabetesd2016” table (see p. S107).
`For the current revision, PPC mem-
`bers systematically searched MEDLINE
`
`for human studies related to each sec-
`tion and published since 1 January
`2015. Recommendations were revised
`based on new evidence or, in some
`cases, to clarify the prior recommenda-
`tion or match the strength of the word-
`ing to the strength of the evidence. A
`table linking the changes in recommen-
`dations to new evidence can be re-
`viewed at http://professional.diabetes
`.org/SOC. As for all position statements,
`the Standards of Care position state-
`ment was reviewed and approved by
`the Executive Committee of ADA’s
`Board of Directors, which includes
`health care professionals, scientists,
`and lay people.
`Feedback from the larger clinical
`community was valuable for the 2016
`revision of the Standards of Care. Readers
`who wish to comment on the Standards
`of Medical Care in Diabetesd2016 are
`invited to do so at http://professional
`.diabetes.org/SOC.
`The ADA funds development of the
`Standards of Care and all ADA position
`statements out of its general revenues
`and does not use industry support for
`these purposes. The PPC would like to
`thank the following individuals who
`provided their expertise in reviewing
`and/or consulting with the committee:
`Lloyd Paul Aiello, MD, PhD; Sheri
`Colberg-Ochs, PhD; Jo Ellen Condon, RD,
`CDE; Donald R. Coustan, MD; Silvio E.
`Inzucchi, MD; George L. King, MD;
`Shihchen Kuo, RPh, PhD; Ira B. Lamster, DDS,
`MMSc; Greg Maynard, MD, MSc, SFHM;
`
`Emma Morton-Eggleston, MD, MPH;
`Margaret A. Powers, PhD, RD, CDE;
`Robert E. Ratner, MD; Erinn Rhodes,
`MD, MPH; Amy Rothberg, MD; Sharon
`D. Solomon, MD; Guillermo E. Umpierrez,
`MD; Willy Valencia, MD; and Kristina F.
`Zdanys, MD.
`
`Members of the PPC
`
`William H. Herman, MD, MPH (Chair)*
`
`Thomas W. Donner, MD
`
`R. James Dudl, MD
`
`Hermes J. Florez, MD, PhD, MPH*
`
`Judith E. Fradkin, MD
`
`Charlotte A. Hayes, MMSc, MS, RD, CDE,
`ACSM CCEP
`
`Rita Rastogi Kalyani, MD, MHS, FACP
`
`Suneil Koliwad, MD, PhD
`
`Joseph A. Stankaitis, MD, MPH*
`
`Tracey H. Taveira, PharmD, CDOE,
`CVDOE*
`
`Deborah J. Wexler, MD, MSc*
`
`Joseph Wolfsdorf, MB, BCh*
`
`*Subgroup leaders
`
`ADA Staff
`Jane L. Chiang, MD
`(Corresponding author:
`jchiang@diabetes.org)
`
`Erika Gebel Berg, PhD
`
`Allison T. McElvaine, PhD
`
`© 2016 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.
`
`Page 10 of 119
`
`

`
`Diabetes Care Volume 39, Supplement 1, January 2016
`
`StandardsofMedicalCareinDiabetesd2016:
`Summary of Revisions
`
`Diabetes Care 2016;39(Suppl. 1):S4–S5 | DOI: 10.2337/dc16-S003
`
`GENERAL CHANGES
`
`In alignment with the American Diabe-
`tes Association’s (ADA’s) position that
`diabetes does not define people, the
`word “diabetic” will no longer be used
`when referring to individuals with dia-
`betes in the “Standards of Medical Care
`in Diabetes.” The ADA will continue to
`use the term “diabetic” as an adjective
`for complications related to diabetes
`(e.g., diabetic retinopathy).
`Although levels of evidence for several
`recommendations have been updated,
`these changes are not included below as
`the clinical recommendations have re-
`mained the same. Changes in evidence
`level from, for example, C to E are not
`noted below. The “Standards of Medical
`Care in Diabetesd2016” contains, in addi-
`tion to many minor changes that clarify
`recommendations or reflect new evidence,
`the following more substantive revisions.
`
`SECTION CHANGES
`Section 1. Strategies for Improving Care
`This section was revised to include rec-
`ommendations on tailoring treatment
`to vulnerable populations with diabetes,
`including recommendations for those
`with food insecurity, cognitive dysfunc-
`tion and/or mental illness, and HIV,
`and a discussion on disparities related
`to ethnicity, culture, sex, socioeconomic
`differences, and disparities.
`
`Section 2. Classification and Diagnosis
`of Diabetes
`The order and discussion of diagnostic
`tests (fasting plasma glucose, 2-h plasma
`glucose after a 75-g oral glucose tolerance
`test, and A1C criteria) were revised to
`make it clear that no one test is preferred
`over another for diagnosis.
`To clarify the relationship between
`age, BMI, and risk for type 2 diabetes
`and prediabetes, the ADA revised the
`
`screening recommendations. The rec-
`ommendation is now to test all adults
`beginning at age 45 years, regardless
`of weight.
`Testing is also recommended for
`asymptomatic adults of any age who
`are overweight or obese and who have
`one or more additional risk factors for
`diabetes. Please refer to Section 2 for
`testing recommendations for gesta-
`tional diabetes mellitus.
`For monogenic diabetes syndromes,
`there is specific guidance and text on
`testing, diagnosing, and evaluating indi-
`viduals and their family members.
`
`Section 3. Foundations of Care and
`Comprehensive Medical Evaluation
`Section 3 “Initial Evaluation and Diabe-
`tes Management Planning” and Section
`4 “Foundations of Care: Education, Nu-
`trition, Physical Activity, Smoking Cessa-
`tion, Psychosocial Care, and Immunization”
`from the 2015 Standards were com-
`bined into one section for 2016 to re-
`flect the importance of integrating
`medical evaluation, patient engage-
`ment, and ongoing care that highlight
`the importance of lifestyle and behav-
`ioral modification. The nutrition and
`vaccination recommendations were
`streamlined to focus on those aspects
`of care most important and most rele-
`vant to people with diabetes.
`
`Section 4. Prevention or Delay of
`Type 2 Diabetes
`To reflect the changing role of technology
`in the prevention of type 2 diabetes, a re-
`commendation was added encouraging
`the use of new technology such as apps
`and text messaging to affect lifestyle
`modification to prevent diabetes.
`
`Section 5. Glycemic Targets
`Because of the growing number of older
`adults with insulin-dependent diabetes,
`
`the ADA added the recommendation
`that people who use continuous glucose
`monitoring and insulin pumps should
`have continued access after they turn
`65 years of age.
`
`Section 6. Obesity Management for
`the Treatment of Type 2 Diabetes
`This new section, which incorporates
`prior recommendations related to bari-
`atric surgery, has new recommenda-
`tions related to the comprehensive
`assessment of weight in diabetes and
`to the treatment of overweight/obesity
`with behavior modification and pharma-
`cotherapy.
`This section also includes a new table
`of currently approved medications for
`the long-term treatment of obesity.
`
`Section 7. Approaches to Glycemic
`Treatment
`Bariatric surgery was removed from this
`section and placed in a new section en-
`titled “Obesity Management for the
`Treatment of Type 2 Diabetes.”
`
`Section 8. Cardiovascular Disease and
`Risk Management
`“Atherosclerotic cardiovascular disease”
`(ASCVD) has replaced the former term
`“cardiovascular disease” (CVD), as
`ASCVD is a more specific term.
`A new recommendation for pharma-
`cological treatment of older adults was
`added.
`To reflect new evidence on ASCVD
`risk among women, the recommenda-
`tion to consider aspirin therapy in
`women aged .60 years has been
`changed to include women aged $50
`years. A recommendation was also
`added to address antiplatelet use in pa-
`tients aged ,50 years with multiple risk
`factors.
`A recommendation was made to re-
`flect new evidence that adding ezetimibe
`
`© 2016 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.
`
`S4
`
`SUMMARYOFREVISIONS
`
`Page 11 of 119
`
`

`
`care.diabetesjournals.org
`
`Summary of Revisions
`
`S5
`
`to moderate-intensity statin provides ad-
`ditional cardiovascular benefits for select
`individuals with diabetes and should be
`considered.
`A new table provides efficacy and
`dose details on high- and moderate-
`intensity statin therapy.
`
`Section 9. Microvascular
`Complications and Foot Care
`“Nephropathy” was changed to “dia-
`betic kidney disease” to emphasize
`that, while nephropathy may stem
`from a variety of causes, attention is
`placed on kidney disease that is directly
`related to diabetes. There are several
`minor edits to this section. The signifi-
`cant ones, based on new evidence, are
`as follows:
`Diabetic kidney disease: guidance was
`added on when to refer for renal re-
`placement treatment and when to refer
`to physicians experienced in the care of
`diabetic kidney disease.
`Diabetic retinopathy: guidance was
`added on the use of intravitreal anti-
`VEGF agents for the treatment of
`center-involved diabetic macular edema,
`as they were more effective than mono-
`therapy or combination therapy with
`laser.
`
`Section 10. Older Adults
`The scope of this section is more compre-
`hensive, capturing the nuances of diabe-
`tes care in the older adult population. This
`
`includes neurocognitive function, hypo-
`glycemia, treatment goals, care in skilled
`nursing facilities/nursing homes, and
`end-of-life considerations.
`
`Section 11. Children and Adolescents
`The scope of this section is more com-
`prehensive, capturing the nuances of di-
`abetes care in the pediatric population.
`This includes new recommendations
`addressing diabetes self-management
`education and support, psychosocial
`issues, and treatment guidelines for
`type 2 diabetes in youth.
`The recommendation to obtain a fast-
`ing lipid profile in children starting at
`age 2 years has been changed to age
`10 years, based on a scientific statement
`on type 1 diabetes and cardiovascular
`disease from the American Heart Asso-
`ciation and the ADA.
`
`Section 12. Management of Diabetes
`in Pregnancy
`The scope of this section is more com-
`prehensive, providing new recommen-
`dations on pregestational diabetes,
`gestational diabetes mellitus, and gen-
`eral principles for diabetes management
`in pregnancy.
`A new recommendation was added to
`highlight the importance of discussing fam-
`ily planning and effective contraception
`with women with preexisting diabetes.
`A1C recommendations for pregnant
`women with diabetes were changed,
`
`from a recommendation of ,6% (42
`mmol/mol) to a target of 6–6.5% (42–
`48 mmol/mol), although depending on
`hypoglycemia risk the target may be
`tightened or relaxed.
`Glyburide in gestational diabetes
`mellitus was deemphasized based on
`new data suggesting that it may be in-
`ferior to insulin and metformin.
`
`Section 13. Diabetes Care in the
`Hospital
`This section was revised to focus solely
`on diabetes care in the hospital setting.
`This comprehensive section addresses
`hospital care delivery standards, more
`detailed information on glycemic tar-
`gets and antihyperglycemic agents,
`standards for special situations, and
`transitions from the acute care setting.
`This section also includes a new table
`on basal and bolus dosing recommenda-
`tions for continuous enteral, bolus en-
`teral, and parenteral feedings.
`
`Section 14. Diabetes Advocacy
`“Diabetes Care in the School Setting: A
`Position Statement of the American Di-
`abetes Association” was revised in 2015.
`This position statement was previously
`called “Diabetes Care in the School and
`Day Care Setting.” The ADA intentionally
`separated these two populations be-
`cause of the significant differences in di-
`abetes care between the two cohorts.
`
`Page 12 of 119
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`

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`S6
`
`Diabetes Care Volume 39, Supplement 1, January 2016
`
`1. Strategies for Improving Care
`
`Diabetes Care 2016;39(Suppl. 1):S6–S12 | DOI: 10.2337/dc16-S004
`
`American Diabetes Association
`
`Suggested citation: American Diabetes Associa-
`tion. Strategies for improving care. Sec. 1. In
`Standards of Medical Care in Diabetesd2016.
`Diabetes Care 2016;39(Suppl. 1):S6–S12
`
`© 2016 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.
`
`Recommendations
`c A patient-centered communication style that incorporates patient prefer-
`ences, assesses literacy and numeracy, and addresses cultural barriers to
`care should be used. B
`c Treatment decisions should be timely and based on evidence-based guide-
`lines that are tailored to individual patient preferences, prognoses, and co-
`morbidities. B
`c