STANDARDS OF MEDICAL CARE IN DIABETES-2015
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TH E JO U R NA L OF C LI N ICA L A N D A PPL I ED R ESEA RC H A N D EDU CATI O N VOLUME 38 | SUPPLEMENT 1
WWW.DIABETES.ORG/DIABETESCARE JANUARY 2015
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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 AT I O N
STANDARDS OF
MEDICAL CARE
IN DIABETES—2015
ISSN 0149-5992
JANUARY 2015 VOLUME 38 | SUPPLEMENT 1 | PAGES S1-S94
American Diabetes Association
Standards of
Medical Care in
Diabetesd2015
January 2015 Volume 38, 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 Nicola Abate, MD Rory J. McCrimmon, MBChB, MD, FRCP
Lawrence Blonde, MD, FACP Silva Arslanian, MD Harold David McIntyre, MD, FRACP
Andrew J.M. Boulton, MD Angelo Avogaro, MD, PhD Sunder Mudaliar, MD
Mary de Groot, PhD Ananda Basu, MD, FRCP Gianluca Perseghin, MD
Eddie L. Greene, MD John B. Buse, MD, PhD Anne L. Peters, MD
Robert Henry, MD Sonia Caprio, MD Jonathan Q. Purnell, MD
Sherita Hill Golden, MD, MHS, FAHA Robert Chilton, DO Peter Reaven, MD
Frank Hu, MD, MPH, PhD Kenneth Cusi, MD, FACP, FACE Helena Wachslicht Rodbard, MD
Derek LeRoith, MD, PhD Paresh Dandona, MD, PhD Pedro Romero-Aroca, PhD
Robert G. Moses, MD Stefano Del Prato, MD David J. Schneider, MD
Stephen Rich, PhD Dariush Elahi, PhD Elizabeth R. Seaquist, MD
Matthew C. Riddle, MD Franco Folli, MD, PhD Norbert Stefan, MD
Julio Rosenstock, MD Robert G. Frykberg, DPM, MPH Jeff Unger, MD
William V. Tamborlane, MD W. Timothy Garvey, MD Ram Weiss, MD, PhD
Katie Weinger, EdD, RN Ronald B. Goldberg, MD Deborah J. Wexler, MD, MSc
Judith Wylie-Rosett, EdD, RD Margaret Grey, DrPH, RN, FAAN Joseph Wolfsdorf, MD, BCh
Richard Hellman, MD Tien Yin Wong, MBBS, FRCSE, FRANZCO,
Rita Rastogi Kalyani, MD, MHS, FACP MPH, PhD
AMERICAN DIABETES ASSOCIATION OFFICERS
CHAIR OF THE BOARD PRESIDENT-ELECT, MEDICINE & SCIENCE
Janel L. Wright, JD Desmond Schatz, MD
PRESIDENT, MEDICINE & SCIENCE PRESIDENT-ELECT, HEALTH CARE &
Samuel Dagogo-Jack, MD, FRCP EDUCATION
Margaret Powers, PhD, RD, CDE
PRESIDENT, HEALTH CARE & EDUCATION
David G. Marrero, PhD SECRETARY/TREASURER-ELECT
Lorrie Welker Liang
SECRETARY/TREASURER
Richard Farber, MBA INTERIM CHIEF EXECUTIVE OFFICER
Suzanne Berry, MBA, CAE
CHAIR OF THE BOARD-ELECT
Robin J. Richardson 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.
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.
Diabetes Care (print ISSN 0149-5992, online ISSN 1935-5548) is owned, controlled, and
published monthly by the American Diabetes Association, Inc., 1701 North Beauregard St.,
Alexandria, VA 22311. Diabetes Care is a registered trademark of the American Diabetes
Association.
Copyright © 2015 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.
Periodicals postage paid at Alexandria, VA, and additional mailing offices.
POSTMASTER: Send address changes to Diabetes Care, American Diabetes Association, Inc.,
PRINT ISSN 0149-5992 Journal Subscriptions, 1701 North Beauregard St., Alexandria, VA 22311. Claims for missing issues
ONLINE ISSN 1935-5548 should be made within 6 months of publication. The publisher expects to supply missing issues free
PRINTED IN THE USA of charge only when losses have been sustained in transit and when the reserve stock permits.
AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS
EDITORIAL OFFICE DIRECTOR EDITORIAL MANAGERS MANAGING DIRECTOR, MEDIA SALES
Lyn Reynolds Valentina Such Clare Liberis
Nancy C. Baldino cliberis@diabetes.org
PEER REVIEW MANAGER
212-725-4925, ext. 3448
Shannon Potts PRODUCTION MANAGER
ASSOCIATE DIRECTOR, BILLING & COLLECTIONS
EDITORIAL ASSISTANT Amy S. Gavin
Laurie Ann Hall
Rita Summers
TECHNICAL EDITOR DIRECTOR, MEMBERSHIP/SUBSCRIPTION
EDITORIAL OFFICE SECRETARIES Oedipa Rice SERVICES
Raquel Castillo Donald Crowl
Joan Garrett VICE PRESIDENT, CORPORATE ALLIANCES ADVERTISING REPRESENTATIVES
Nancy Stinson Harris The Jackson-Gaeta Group, Inc.
MANAGING DIRECTOR, SCHOLARLY
JOURNAL PUBLISHING
B. Joseph Jackson
ADVERTISING MANAGER bartjack@aol.com
Christian S. Kohler
Julie DeVoss Graff Paul Nalbandian
DIRECTOR, SCHOLARLY JOURNAL PUBLISHING jdevoss@diabetes.org pnalbandian4ada@aol.com
Heather L. Norton (703) 299-5511 (973) 403-7677
January 2015 Volume 38, Supplement 1
Standards of Medical Care in Diabetes—2015
S1 Introduction S49 8. Cardiovascular Disease and Risk Management
S3 Professional Practice Committee Hypertension/Blood Pressure Control
Dyslipidemia/Lipid Management
S4 Standards of Medical Care in Diabetes—2015: Antiplatelet Agents
Summary of Revisions Coronary Heart Disease
S5 1. Strategies for Improving Care
S58 9. Microvascular Complications and Foot Care
Diabetes Care Concepts
Care Delivery Systems Nephropathy
When Treatment Goals Are Not Met Retinopathy
Neuropathy
S8 2. Classification and Diagnosis of Diabetes Foot Care
Classification S67 10. Older Adults
Diagnostic Tests for Diabetes
Categories of Increased Risk for Diabetes Treatment Goals
(Prediabetes) Hypoglycemia
Type 1 Diabetes Pharmacological Therapy
Type 2 Diabetes S70 11. Children and Adolescents
Gestational Diabetes Mellitus
Monogenic Diabetes Syndromes Type 1 Diabetes
Cystic Fibrosis–Related Diabetes Type 2 Diabetes
Psychosocial Issues
S17 3. Initial Evaluation and Diabetes Management
Planning S77 12. Management of Diabetes in Pregnancy
Medical Evaluation Diabetes in Pregnancy
Management Plan Preconception Counseling
Common Comorbid Conditions Glycemic Targets in Pregnancy
S20 4. Foundations of Care: Education, Nutrition, Pregnancy and Antihypertensive Drugs
Physical Activity, Smoking Cessation, Management of Gestational Diabetes Mellitus
Psychosocial Care, and Immunization Management of Pregestational Type 1 Diabetes
and Type 2 Diabetes in Pregnancy
Diabetes Self-management Education and Support Postpartum Care
Medical Nutrition Therapy
Physical Activity S80 13. Diabetes Care in the Hospital, Nursing Home,
Smoking Cessation and Skilled Nursing Facility
Psychosocial Assessment and Care Hyperglycemia in the Hospital
Immunization Glycemic Targets in Hospitalized Patients
S31 5. Prevention or Delay of Type 2 Diabetes Antihyperglycemic Agents in Hospitalized Patients
Preventing Hypoglycemia
Lifestyle Modifications Diabetes Care Providers in the Hospital
Pharmacological Interventions Self-management in the Hospital
Diabetes Self-management Education and Support Medical Nutrition Therapy in the Hospital
S33 6. Glycemic Targets Bedside Blood Glucose Monitoring
Discharge Planning
Assessment of Glycemic Control Diabetes Self-management Education
A1C Goals
Hypoglycemia S86 14. Diabetes Advocacy
Intercurrent Illness
Advocacy Position Statements
S41 7. Approaches to Glycemic Treatment
S88 Professional Practice Committee for the Standards
Pharmacological Therapy for Type 1 Diabetes of Medical Care in Diabetes—2015
Pharmacological Therapy for Type 2 Diabetes
Bariatric Surgery S90 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).
Diabetes Care Volume 38, Supplement 1, January 2015 S1
INTRODUCTION
Introduction
Diabetes Care 2015;38(Suppl. 1):S1–S2 | DOI: 10.2337/dc15-S001
Diabetes is a complex, chronic illness re- ADA STANDARDS, STATEMENTS, ADA Scientific Statement
quiring continuous medical care with AND REPORTS A scientific statement is an official
multifactorial risk-reduction strategies The ADA has been actively involved in ADA point of view or belief that may or
beyond glycemic control. Ongoing pa- the development and dissemination of may not contain clinical or research rec-
tient self-management education and diabetes care standards, guidelines, and ommendations. Scientific statements
support are critical to preventing acute related documents for over 20 years. contain scholarly synopsis of a topic re-
complications and reducing the risk of ADA’s clinical practice recommenda- lated to diabetes. Workgroup reports
long-term complications. Significant tions are viewed as important resources fall into this category. Scientific state-
evidence exists that supports a range for health care professionals who care ments are published in the ADA journals
of interventions to improve diabetes for people with diabetes. ADA’s “Stan- and other scientific/medical publications,
outcomes. dards of Medical Care in Diabetes,” as appropriate. Scientific statements also
The American Diabetes Association’s position statements, and scientific undergo a formal review process.
(ADA’s) “Standards of Medical Care in statements undergo a formal review
Diabetes” is intended to provide cli- process by ADA’s Professional Practice Consensus Report
nicians, patients, researchers, payers, Committee (PPC) and the Executive A consensus report contains a compre-
and other interested individuals with Committee of the Board of Directors. hensive examination by an expert panel
the components of diabetes care, gen- The Standards and all ADA position state- (i.e., consensus panel) of a scientific or
eral treatment goals, and tools to eval- ments, scientific statements, and consensus medical issue related to diabetes. A con-
uate the quality of care. The Standards reports are available on the Association’s sensus report is not an ADA position and
of Care recommendations are not in- Web site at http://professional.diabetes.org/ represents expert opinion only. The cat-
tended to preclude clinical judgment adastatements. egory may also include task force and
and must be applied in the context of expert committee reports. The need
excellent clinical care, with adjustments “Standards of Medical Care in Diabetes” for a consensus report arises when clini-
for individual preferences, comorbid- Standards of Care: ADA position state- cians or scientists desire guidance on
ities, and other patient factors. For ment that provides key clinical practice a subject for which the evidence is con-
more detailed information about man- recommendations. The PPC performs an tradictory or incomplete. A consensus
agement of diabetes, please refer to extensive literature search and updates report is typically developed immedi-
Medical Management of Type 1 Diabetes the Standards annually based on the ately following a consensus conference
(1) and Medical Management of Type 2 quality of new evidence. where the controversial issue is exten-
Diabetes (2). sively discussed. The report represents
The recommendations include screen- ADA Position Statement the panel’s collective analysis, evalua-
ing, diagnostic, and therapeutic actions A position statement is an official ADA tion, and opinion at that point in time
that are known or believed to favor- point of view or belief that contains clinical based in part on the conference pro-
ably affect health outcomes of patients or research recommendations. Position ceedings. A consensus report does not
with diabetes. Many of these interven- statements are issued on scientific or med- undergo a formal ADA review process.
tions have also been shown to be cost- ical issues related to diabetes. They are
effective (3). published in ADA journals and other scien- GRADING OF SCIENTIFIC EVIDENCE
The ADA strives to improve and update tific/medical publications. ADA position Since the ADA first began publishing
the Standards of Care to ensure that clini- statements are typically based on a sys- practice guidelines, there has been con-
cians, health plans, and policy makers can tematic review or other review of pub- siderable evolution in the evaluation of
continue to rely on them as the most au- lished literature. Position statements scientific evidence and in the develop-
thoritative and current guidelines for di- undergo a formal review process. They ment of evidence-based guidelines.
abetes care. are updated annually or as needed. In 2002, we developed a classification
“Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: October 2014.
© 2015 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.S2 Introduction Diabetes Care Volume 38, Supplement 1, January 2015
Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes” recommendations have the best chance
Level of
of improving outcomes when applied to
evidence Description the population to which they are appro-
priate. Recommendations with lower
A Clear evidence from well-conducted, generalizable randomized controlled
trials that are adequately powered, including
levels of evidence may be equally impor-
c Evidence from a well-conducted multicenter trial tant but are not as well supported.
c Evidence from a meta-analysis that incorporated quality ratings in the Of course, evidence is only one com-
analysis ponent of clinical decision making. Clini-
Compelling nonexperimental evidence; i.e., “all or none” rule developed by cians care for patients, not populations;
the Centre for Evidence-Based Medicine at the University of Oxford guidelines must always be interpreted
Supportive evidence from well-conducted randomized controlled trials that
with the individual patient in mind.
are adequately powered, including
c Evidence from a well-conducted trial at one or more institutions
Individual circumstances, such as co-
c Evidence from a meta-analysis that incorporated quality ratings in the morbid and coexisting diseases, age, ed-
analysis ucation, disability, and, above all,
B Supportive evidence from well-conducted cohort studies patients’ values and preferences, must
c Evidence from a well-conducted prospective cohort study or registry be considered and may lead to different
c Evidence from a well-conducted meta-analysis of cohort studies treatment targets and strategies. Also,
Supportive evidence from a well-conducted case-control study conventional evidence hierarchies, such
C Supportive evidence from poorly controlled or uncontrolled studies as the one adapted by the ADA, may
c Evidence from randomized clinical trials with one or more major or three
miss nuances important in diabetes
or more minor methodological flaws that could invalidate the results
c Evidence from observational studies with high potential for bias (such as
care. For example, although there is ex-
case series with comparison with historical controls) cellent evidence from clinical trials sup-
c Evidence from case series or case reports porting the importance of achieving
Conflicting evidence with the weight of evidence supporting the multiple risk factor control, the optimal
recommendation way to achieve this result is less clear. It
E Expert consensus or clinical experience is difficult to assess each component of
such a complex intervention.
system to grade the quality of scienti- and codify the evidence that forms the References
fic evidence supporting ADA recommen- basis for the recommendations. 1. Kaufman FR (Ed.). Medical Management of
dations for all new and revised ADA ADA recommendations are assigned Type 1 Diabetes, 6th ed. Alexandria, VA, Amer-
position statements. A recent analysis ratings of A, B, or C, depending on the ican Diabetes Association, 2012
of the evidence cited in the Standards quality of evidence. Expert opinion E is a 2. Burant CF (Ed.). Medical Management of
Type 2 Diabetes, 7th ed. Alexandria, VA, Amer-
of Care found steady improvement in separate category for recommendations ican Diabetes Association, 2012
quality over the past 10 years, with last in which there is no evidence from clin- 3. Li R, Zhang P, Barker LE, Chowdhury FM,
year’s Standards for the first time having ical trials, in which clinical trials may Zhang X. Cost-effectiveness of interventions to
the majority of bulleted recommenda- be impractical, or in which there is con- prevent and control diabetes mellitus: a system-
tions supported by A- or B-level evi- flicting evidence. Recommendations atic review. Diabetes Care 2010;33:1872–1894
4. Grant RW, Kirkman MS. Trends in the evi-
dence (4). A grading system (Table 1) with an A rating are based on large dence level for the American Diabetes Associa-
developed by ADA and modeled after well-designed clinical trials or well- tion’s “Standards of Medical Care in Diabetes”
existing methods was used to clarify done meta-analyses. Generally, these from 2005 to 2014. Diabetes Care 2015;38:6–8Diabetes Care Volume 38, Supplement 1, January 2015
PROFESSIONAL PRACTICE COMMITTEE
S3
Professional Practice Committee
Diabetes Care 2015;38(Suppl. 1):S3 | DOI: 10.2337/dc15-S002
The Professional Practice Committee for human studies related to each sec- Edward W. Gregg, PhD; Silvio E. Inzucchi,
(PPC) of the American Diabetes Associa- tion and published since 1 January 2014. MD; Mark E. Molitch, MD; John M.
tion (ADA) is responsible for the “Stan- Recommendations were revised based Morton, MD; Robert E. Ratner, MD;
dards of Medical Care in Diabetes” on new evidence or, in some cases, to Linda M. Siminerio, RN, PhD, CDE; and
position statement, referred to as the clarify the prior recommendation or Katherine R. Tuttle, MD.
“Standards of Care.” The PPC is a multidis- match the strength of the wording to
ciplinary expert committee comprised of the strength of the evidence. A table link- Members of the PPC
physicians, diabetes educators, registered ing the changes in recommendations to
dietitians, and others who have expertise new evidence can be reviewed at http:// Richard W. Grant, MD, MPH (Chair)*
in a range of areas, including adult and professional.diabetes.org/SOC. As for Thomas W. Donner, MD
pediatric endocrinology, epidemiology, all position statements, the Standards Judith E. Fradkin, MD
public health, lipid research, hypertension, of Care position statement was reviewed
and preconception and pregnancy care. and approved by the Executive Committee Charlotte Hayes, MMSc, MS, RD, CDE,
Appointment to the PPC is based on excel- of ADA’s Board of Directors, which in- ACSM CES
lence in clinical practice and/or research. cludes health care professionals, scientists, William H. Herman, MD, MPH
While the primary role of the PPC is to and lay people. William C. Hsu, MD
review and update the Standards of Feedback from the larger clinical
Eileen Kim, MD
Care, it is also responsible for overseeing community was valuable for the 2015
the review and revisions of ADA’s position revision of the Standards of Care. Read- Lori Laffel, MD, MPH
statements and scientific statements. ers who wish to comment on the Stan- Rodica Pop-Busui, MD, PhD
All members of the PPC are required dards of Medical Care in Diabetesd2015
Neda Rasouli, MD*
to disclose potential conflicts of interest are invited to do so at http://professional
with industry and/or other relevant or- .diabetes.org/SOC. Desmond Schatz, MD
ganizations. These disclosures are dis- The ADA funds development of the Joseph A. Stankaitis, MD, MPH*
cussed at the onset of each Standards Standards of Care and all ADA position Tracey H. Taveira, PharmD, CDOE,
of Care revision meeting. Members of statements out of its general revenues CVDOE
the committee, their employer, and and does not use industry support for
their disclosed conflicts of interest are these purposes. Deborah J. Wexler, MD*
listed in the “Professional Practice Com- The PPC would like to thank the fol- *Subgroup leaders
mittee for the Standards of Medical lowing individuals who provided their ex-
Care in Diabetesd2015” table (see pertise in reviewing and/or consulting with ADA Staff
p. S88). the committee: Donald R. Coustan, MD;
For the current revision, PPC mem- Stephanie Dunbar, MPH, RD; Robert H. Jane L. Chiang, MD
bers systematically searched MEDLINE Eckel, MD; Henry N. Ginsberg, MD; Erika Gebel Berg, PhD
© 2015 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 Diabetes Care Volume 38, Supplement 1, January 2015
SUMMARY OF REVISIONS
Standards of Medical Care in Diabetesd2015 :
Summary of Revisions
Diabetes Care 2015;38(Suppl. 1):S4 | DOI: 10.2337/dc15-S003
GENERAL CHANGES Section 4. Foundations of Care: reflect evidence from randomized clinical
Diabetes Care Supplement 1 was previ- Education, Nutrition, Physical Activity, trials. Lower diastolic targets may still be
ously called Clinical Practice Recommen- Smoking Cessation, Psychosocial Care, appropriate for certain individuals.
dations and included the “Standards of and Immunization Recommendations for statin treat-
Medical Care in Diabetes” and key The physical activity section was revised ment and lipid monitoring were revised
American Diabetes Association (ADA) to reflect evidence that all individuals, after consideration of 2013 American
position statements. The supplement including those with diabetes, should College of Cardiology/American Heart
has been renamed Standards of Medical be encouraged to limit the amount of Association guidelines on the treatment
Care in Diabetes (“Standards”) and time they spend being sedentary by of blood cholesterol. Treatment initia-
contains a single ADA position state- breaking up extended amounts of time tion (and initial statin dose) is now
ment that provides evidence-based clin- (.90 min) spent sitting. driven primarily by risk status rather
ical practice recommendations for Due to the increasing use of e-cigarettes, than LDL cholesterol level.
diabetes care. the Standards were updated to make clear With consideration for the new
Whereas the “Standards of Medical that e-cigarettes are not supported as an statin treatment recommendations, the
Care in Diabetesd2015” should still alternative to smoking or to facilitate Standards now provide the following
be viewed as a single document, it has smoking cessation. lipid monitoring guidance: a screening
been divided into 14 sections, each in- Immunization recommendations were lipid profile is reasonable at diabetes di-
dividually referenced, to highlight im- revised to reflect recent Centers for Disease agnosis, at an initial medical evaluation
portant topic areas and to facilitate Control and Prevention guidelines re- and/or at age 40 years, and periodically
navigation. garding PCV13 and PPSV23 vaccinations thereafter.
The supplement now includes an in- in older adults.
dex to help readers find information on Section 9. Microvascular
Section 6. Glycemic Targets Complications and Foot Care
particular topics.
The ADA now recommends a premeal To better target those at high risk for
SECTION CHANGES blood glucose target of 80–130 mg/dL, foot complications, the Standards em-
rather than 70–130 mg/dL, to better re- phasize that all patients with insensate
Although the levels of evidence for sev- flect new data comparing actual average
eral recommendations have been up- feet, foot deformities, or a history of
glucose levels with A1C targets. foot ulcers have their feet examined at
dated, these changes are not included To provide additional guidance on the
below as the clinical recommendations every visit.
successful implementation of continuous
have remained the same. Changes in ev- glucose monitoring (CGM), the Standards
idence level from, for example, C to E are Section 11. Children and Adolescents
include new recommendations on assessing To reflect new evidence regarding the
not noted below. The “Standards of a patient’s readiness for CGM and on
Medical Care in Diabetesd2015” con- risks and benefits of tight glycemic con-
providing ongoing CGM support. trol in children and adolescents with di-
tains, in addition to many minor changes
that clarify recommendations or reflect abetes, the Standards now recommend
Section 7. Approaches to Glycemic
new evidence, the following more sub- a target A1C of ,7.5% for all pediatric
Treatment
stantive revisions. The type 2 diabetes management algo- age-groups; however, individualization is
rithm was updated to reflect all of the still encouraged.
Section 2. Classification and currently available therapies for diabe-
Diagnosis of Diabetes tes management. Section 12. Management of Diabetes
The BMI cut point for screening over- in Pregnancy
weight or obese Asian Americans for pre- Section 8. Cardiovascular Disease and This new section was added to the
diabetes and type 2 diabetes was changed Risk Management Standards to provide recommendations
to 23 kg/m2 (vs. 25 kg/m2) to reflect The recommended goal for diastolic related to pregnancy and diabetes, in-
the evidence that this population is at an blood pressure was changed from 80 cluding recommendations regarding
increased risk for diabetes at lower BMI mmHg to 90 mmHg for most people preconception counseling, medications,
levels relative to the general population. with diabetes and hypertension to better blood glucose targets, and monitoring.
© 2015 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.Diabetes Care Volume 38, Supplement 1, January 2015 S5
American Diabetes Association
1. Strategies for Improving Care
Diabetes Care 2015;38(Suppl. 1):S5–S7 | DOI: 10.2337/dc15-S004
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 founded on evidence-based guide-
lines that are tailored to individual patient preferences, prognoses, and
comorbidities. B
c Care should be aligned with components of the Chronic Care Model (CCM) to
ensure productive interactions between a prepared proactive practice team
and an informed activated patient. A
POSITION STATEMENT
c When feasible, care systems should support team-based care, community
involvement, patient registries, and decision support tools to meet patient
needs. B
DIABETES CARE CONCEPTS
In the following sections, different components of the clinical management of
patients with (or at risk for) diabetes are reviewed. We highlight the following three
themes that are woven throughout these sections that clinicians, policymakers, and
advocates should keep in mind:
1. Patient-Centeredness: Practice recommendations, whether based on evidence or
expert opinion, are intended to guide an overall approach to care. The science and art
of medicine come together when the clinician is faced with making treatment recom-
mendations for a patient who would not have met eligibility criteria for the studies on
which guidelines were based. Recognizing that one size does not fit all, these Standards
provide guidance for when and how to adapt recommendations (e.g., see Section 10.
Older Adults and Fig. 6.1. Approach to the Management of Hyperglycemia). Because
patients with diabetes are also at greatly increased risk of cardiovascular disease, a
patient-centered approach should include a comprehensive plan to reduce cardiovas-
cular risk by addressing blood pressure and lipid control, smoking cessation, weight
management, and healthy lifestyle changes that include adequate physical activity.
2. Diabetes Across the Life Span: An increasing proportion of patients with type 1
diabetes are adults. Conversely, and for less salutary reasons, the incidence of type
2 diabetes is increasing in children and young adults. Finally, patients both with type
1 diabetes and with type 2 diabetes are living well into older age, a stage of life for
which there is little evidence from clinical trials to guide therapy. All these de-
mographic changes highlight another challenge to high-quality diabetes care, which
is the need to improve coordination between clinical teams as patients pass through
different stages of the life span or the stages of pregnancy (preconception, preg-
nancy, and postpartum).
3. Advocacy for Patients With Diabetes: Advocacy can be defined as active support
and engagement to advance a cause or policy. Advocacy in the cause of improving the
lives of patients with (or at risk for) diabetes is an ongoing need. Given the tremendous Suggested citation: American Diabetes Associa-
toll that lifestyle factors such as obesity, physical inactivity, and smoking have on the tion. Strategies for improving care. Sec. 1. In
Standards of Medical Care in Diabetesd2015.
health of patients with diabetes, ongoing and energetic efforts are needed to address
Diabetes Care 2015;38(Suppl. 1):S5–S7
and change the societal determinants at the root of these problems. Within the more
© 2015 by the American Diabetes Association.
narrow domain of clinical practice guidelines, the application of evidence level grading Readers may use this article as long as the work
to practice recommendations can help identify areas that require more research is properly cited, the use is educational and not
investment (1). This topic is explored in more depth in Section 14. Diabetes Advocacy. for profit, and the work is not altered.S6 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015
CARE DELIVERY SYSTEMS to the care team), 5) community resources diabetes self-management education
There has been steady improvement in the and policies (identifying or developing (DSME) has been shown to improve pa-
proportion of diabetic patients achieving resources to support healthy lifestyles), tient self-management, satisfaction, and
recommended levels of A1C, blood pres- and 6) health systems (to create a quality- glucose control (25,26), as has delivery of
sure, and LDL cholesterol in the last 10 oriented culture). Redefining the roles ongoing diabetes self-management sup-
years (2). The mean A1C nationally has of the clinic staff and promoting self- port (DSMS), so that gains achieved during
declined from 7.6% in 1999–2002 to management on the part of the patient DSME are sustained (27–29). National
7.2% in 2007–2010 based on the National are fundamental to the successful imple- DSME standards call for an integrated ap-
Health and Nutrition Examination Survey mentation of the CCM (8). Collaborative, proach that includes clinical content and
(NHANES) data (E.W. Gregg, Centers for multidisciplinary teams are best suited to skills, behavioral strategies (goal setting,
Disease Control and Prevention, personal provide care for people with chronic con- problem solving), and engagement with
communication). This has been accompa- ditions such as diabetes and to facilitate emotional concerns in each needed curric-
nied by improvements in lipids and blood patients’ self-management (9–12). ulum content area.
pressure control and has led to substantial Key Objectives Objective 3: Change the Care System
reductions in end-stage microvascular The National Diabetes Education Pro- An institutional priority in most successful
complications in patients with diabetes. gram (NDEP) maintains an online resource care systems is providing a high quality of
Nevertheless, between 33 and 49% of pa- (www.betterdiabetescare.nih.gov) to help care (30). Changes that have been shown
tients still do not meet targets for glyce- health care professionals design and im- to increase quality of diabetes care in-
mic, blood pressure, or cholesterol control, plement more effective health care de- clude basing care on evidence-based
and only 14% meet targets for all three livery systems for those with diabetes. guidelines (19); expanding the role of
measures and nonsmoking status (2). Evi- Three specific objectives, with refer- teams and staff and implementing more
dence also suggests that progress in car- ences to literature that outlines practical intensive disease management strategies
diovascular risk factor control (particularly strategies to achieve each, are delin- (6,22,31); redesigning the care process
tobacco use) may be slowing (2,3). Certain eated below. (32); implementing electronic health re-
patient groups, such as young adults and cord tools (33,34); activating and educat-
Objective 1: Optimize Provider and Team
patients with complex comorbidities, fi- ing patients (35,36); removing financial
Behavior
nancial or other social hardships, and/or barriers and reducing patient out-of-
The care team should prioritize timely and
limited English proficiency, may present pocket costs for diabetes education, eye
appropriate intensification of lifestyle and/
particular challenges to goal-based care exams, self-monitoring of blood glucose,
or pharmaceutical therapy for patients who
(4–6). Persistent variation in quality of di- and necessary medications (6); and iden-
have not achieved beneficial levels of blood
abetes care across providers and across tifying/developing/engaging community
pressure, lipid, or glucose control (13).
practice settings even after adjusting for resources and public policy that support
Strategies such as explicit goal setting
patient factors indicates that there re- healthy lifestyles (37). Recent initiatives
with patients (14); identifying and address-
mains potential for substantial system- such as the Patient-Centered Medical
ing language, numeracy, or cultural barriers
level improvements in diabetes care. Home show promise for improving out-
to care (15–18); integrating evidence-based
comes through coordinated primary care
Chronic Care Model guidelines and clinical information tools
and offer new opportunities for team-
Although numerous interventions to im- into the process of care (19–21); and incor-
based chronic disease care (38). Addi-
prove adherence to the recommended porating care management teams including
tional strategies to improve diabetes
standards have been implemented, a ma- nurses, pharmacists, and other providers
care include reimbursement structures
jor barrier to optimal care is a delivery (22–24) have each been shown to optimize
that, in contrast to visit-based billing, re-
system that too often is fragmented, lacks provider and team behavior and thereby
ward the provision of appropriate and
clinical information capabilities, dupli- catalyze reductions in A1C, blood pressure,
high-quality care (39), and incentives
cates services, and is poorly designed and LDL cholesterol.
that accommodate personalized care
for the coordinated delivery of chronic Objective 2: Support Patient Behavior goals (6,40).
care. The CCM has been shown to be an Change It is clear that optimal diabetes man-
effective framework for improving the Successful diabetes care requires a sys- agement requires an organized, system-
quality of diabetes care (7). The CCM in- tematic approach to supporting patients’ atic approach and the involvement of a
cludes six core elements for the provision behavior change efforts, including 1) coordinated team of dedicated health
of optimal care of patients with chronic healthy lifestyle changes (physical activity, care professionals working in an envi-
disease: 1) delivery system design (mov- healthy eating, tobacco cessation, weight ronment where patient-centered high-
ing from a reactive to a proactive care management, and effective coping), 2) quality care is a priority (6).
delivery system where planned visits disease self-management (taking and
are coordinated through a team-based managing medication and, when clinically
approach, 2) self-management support, appropriate, self-monitoring of glucose WHEN TREATMENT GOALS ARE
3) decision support (basing care on and blood pressure), and 3) prevention NOT MET
evidence-based, effective care guide- of diabetes complications (self-monitoring Some patients and their health care pro-
lines), 4) clinical information systems of foot health; active participation in viders may not achieve the desired
(using registries that can provide patient- screening for eye, foot, and renal compli- treatment goals. Reassessing the treat-
specific and population-based support cations; and immunizations). High-quality ment regimen may require evaluation ofcare.diabetesjournals.org Position Statement S7
barriers such as income, health literacy, a systematic review. Diabetes Care 2001;24: 26. Berikai P, Meyer PM, Kazlauskaite R, Savoy
diabetes-related distress, depression, 1821–1833 B, Kozik K, Fogelfeld L. Gain in patients’ knowl-
11. Katon WJ, Lin EHB, Von Korff M, et al. Col- edge of diabetes management targets is associ-
poverty, and competing demands, in- laborative care for patients with depression and ated with better glycemic control. Diabetes
cluding those related to family respon- chronic illnesses. N Engl J Med 2010;363:2611– Care 2007;30:1587–1589
sibilities and dynamics. Other strategies 2620 27. Funnell MM, Brown TL, Childs BP, et al. Na-
may include culturally appropriate and 12. Parchman ML, Zeber JE, Romero RR, Pugh tional standards for diabetes self-management
enhanced DSME and DSMS, comanage- JA. Risk of coronary artery disease in type 2 di- education. Diabetes Care 2007;30:1630–1637
abetes and the delivery of care consistent with 28. Klein S, Sheard NF, Pi-Sunyer X, et al.
ment with a diabetes team, referral to a the chronic care model in primary care settings:
medical social worker for assistance Weight management through lifestyle modifica-
a STARNet study. Med Care 2007;45:1129–
tion for the prevention and management of
with insurance coverage, medication- 1134
type 2 diabetes: rationale and strategies: a state-
taking behavior assessment, or change 13. Davidson MB. How our current medical
ment of the American Diabetes Association, the
in pharmacological therapy. Initiation of care system fails people with diabetes: lack of
timely, appropriate clinical decisions. Diabetes North American Association for the Study of
or increase in self-monitoring of blood Care 2009;32:370–372 Obesity, and the American Society for Clinical
glucose, continuous glucose monitoring, 14. Grant RW, Pabon-Nau L, Ross KM, Youatt EJ, Nutrition. Diabetes Care 2004;27:2067–2073
frequent patient contact, or referral to a Pandiscio JC, Park ER. Diabetes oral medication 29. Norris SL, Zhang X, Avenell A, et al. Efficacy
initiation and intensification: patient views of pharmacotherapy for weight loss in adults
mental health professional or physician
compared with current treatment guidelines. with type 2 diabetes mellitus: a meta-analysis.
with special expertise in diabetes may Arch Intern Med 2004;164:1395–1404
Diabetes Educ 2011;37:78–84
be useful. 15. Schillinger D, Piette J, Grumbach K, et al. 30. Tricco AC, Ivers NM, Grimshaw JM, et al.
Closing the loop: physician communication Effectiveness of quality improvement strategies
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American Diabetes Association
2. Classification and Diagnosis of
Diabetes
Diabetes Care 2015;38(Suppl. 1):S8–S16 | DOI: 10.2337/dc15-S005
CLASSIFICATION
Diabetes can be classified into the following general categories:
1. Type 1 diabetes (due to b-cell destruction, usually leading to absolute insulin
deficiency)
2. Type 2 diabetes (due to a progressive insulin secretory defect on the background
of insulin resistance)
3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third
trimester of pregnancy that is not clearly overt diabetes)
POSITION STATEMENT
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]), dis-
eases of the exocrine pancreas (such as cystic fibrosis), and drug- or chemical-induced
diabetes (such as 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).
Assigning a type of diabetes to an individual often depends on the circumstances
present at the time of diagnosis, with individuals not necessarily fitting clearly into a
single category. For example, some patients cannot be clearly classified as having
type 1 or type 2 diabetes. Clinical presentation and disease progression may vary
considerably in both types of diabetes.
The traditional paradigms of type 2 diabetes occurring only in adults and type 1
diabetes only in children are no longer accurate, as both diseases occur in both cohorts.
Occasionally, patients with type 2 diabetes may present with diabetic ketoacidosis
(DKA). Children with type 1 diabetes typically present with the hallmark symptoms
of polyuria/polydipsia and occasionally with DKA. The onset of type 1 diabetes may be
variable in adults and may not present with the classic symptoms seen in children.
However, difficulties in diagnosis may occur in children, adolescents, and adults, with
the true diagnosis becoming more obvious over time.
DIAGNOSTIC TESTS FOR DIABETES
Diabetes may be diagnosed based on A1C criteria or plasma glucose criteria, either the
fasting plasma glucose (FPG) or the 2-h plasma glucose (2-h PG) value after a 75-g oral
glucose tolerance test (OGTT) (1,2) (Table 2.1).
The same tests are used to both screen for and diagnose diabetes. Diabetes may
be identified anywhere along the spectrum of clinical scenarios: in seemingly low-
risk individuals who happen to have glucose testing, in symptomatic patients, and in
higher-risk individuals whom the provider tests because of a suspicion of diabetes.
The same tests will also detect individuals with prediabetes.
A1C
The A1C test should be performed using a method that is certified by the NGSP and
standardized or traceable to the Diabetes Control and Complications Trial (DCCT) Suggested citation: American Diabetes Association.
reference assay. Although point-of-care (POC) A1C assays may be NGSP certified, Classification and diagnosis of diabetes. Sec. 2.
In Standards of Medical Care in Diabetesd2015.
proficiency testing is not mandated for performing the test, so use of POC assays for
Diabetes Care 2015;38(Suppl. 1):S8–S16
diagnostic purposes may be problematic and is not recommended.
© 2015 by the American Diabetes Association.
The A1C has several advantages to the FPG and OGTT, including greater conve- Readers may use this article as long as the work
nience (fasting not required), greater preanalytical stability, and less day-to-day is properly cited, the use is educational and not
perturbations during stress and illness. These advantages must be balanced by for profit, and the work is not altered.care.diabetesjournals.org Position Statement S9
Hemoglobinopathies/Anemias FPG (,126 mg/dL [7.0 mmol/L]), that
Table 2.1—Criteria for the diagnosis
of diabetes Interpreting A1C levels in the presence of person should nevertheless be consid-
A1C $6.5%. The test should be performed certain hemoglobinopathies and anemia ered to have diabetes.
in a laboratory using a method that is may be problematic. For patients with an Since all the tests have preanalytic and
NGSP certified and standardized to the abnormal hemoglobin but normal red cell analytic variability, it is possible that an ab-
DCCT assay.* turnover, such as those with the sickle cell normal result (i.e., above the diagnostic
OR trait, an A1C assay without interference threshold), when repeated, will produce
FPG $126 mg/dL (7.0 mmol/L). Fasting is from abnormal hemoglobins should be a value below the diagnostic cut point.
defined as no caloric intake for at least used. An updated list of interferences is This scenario is least likely for A1C, more
8 h.*
available at www.ngsp.org/interf.asp. In likely for FPG, and most likely for the 2-h
OR
conditions associated with increased red PG, especially if the glucose samples are
2-h PG $200 mg/dL (11.1 mmol/L) during cell turnover, such as pregnancy (second collected at room temperature and not
an OGTT. The test should be performed
and third trimesters), recent blood loss centrifuged promptly. Barring labora-
as described by the WHO, using
a glucose load containing the or transfusion, erythropoietin therapy, tory error, such patients will likely
equivalent of 75 g anhydrous glucose or hemolysis, only blood glucose criteria have test results near the margins of
dissolved in water.* should be used to diagnose diabetes. the diagnostic threshold. The health
OR care professional should follow the
In a patient with classic symptoms of Fasting and 2-Hour Plasma Glucose patient closely and repeat the test in
hyperglycemia or hyperglycemic crisis, In addition to the A1C test, the FPG and 3–6 months.
a random plasma glucose $200 mg/dL 2-h PG may also be used to diagnose diabe-
(11.1 mmol/L).
tes (Table 2.1). The concordance between CATEGORIES OF INCREASED RISK
*In the absence of unequivocal the FPG and 2-h PG tests is imperfect, as FOR DIABETES (PREDIABETES)
hyperglycemia, results should be confirmed is the concordance between A1C and ei-
by repeat testing.
ther glucose-based test. National Health Recommendations
and Nutrition Examination Survey
c Testing to assess risk for future di-
(NHANES) data indicate that an A1C cut
abetes in asymptomatic people
greater cost, the limited availability of point of $6.5% identifies one-third
should be considered in adults of
A1C testing in certain regions of the fewer cases of undiagnosed diabetes
any age who are overweight or
than a fasting glucose cut point of
developing world, and the incomplete obese (BMI $25 kg/m 2 or $23
$126 mg/dL (7.0 mmol/L) (9). Numer-
correlation between A1C and average kg/m 2 in Asian Americans) and
glucose in certain individuals. ous studies have confirmed that, com-
who have one or more additional
It is important to take age, race/ pared with these A1C and FPG cut
risk factors for diabetes. For all
ethnicity, and anemia/hemoglobinopathies points, the 2-h PG value diagnoses
patients, particularly those who
into consideration when using the A1C to more people with diabetes. Of note,
are overweight or obese, testing
the lower sensitivity of A1C at the desig-
diagnose diabetes. should begin at age 45 years. B
nated cut point may be offset by the
Age c If tests are normal, repeat testing
test’s ease of use and facilitation of
The epidemiological studies that formed carried out at a minimum of 3-
more widespread testing.
the framework for recommending A1C year intervals is reasonable. C
Unless there is a clear clinical diagno-
to diagnose diabetes only included adult c To test for prediabetes, the A1C,
sis (e.g., a patient in a hyperglycemic
populations. Therefore, it remains un- FPG, and 2-h PG after 75-g OGTT
crisis or with classic symptoms of hyper-
clear if A1C and the same A1C cut point are appropriate. B
glycemia and a random plasma glucose
should be used to diagnose diabetes in c In patients with prediabetes, iden-
$200 mg/dL), it is recommended that
children and adolescents (3–5). tify and, if appropriate, treat other
the same test be repeated immediately
cardiovascular disease (CVD) risk
Race/Ethnicity using a new blood sample for confirma-
factors. B
A1C levels may vary with patients’ race/ tion because there will be a greater like-
c Testing to detect prediabetes
ethnicity (6,7). For example, African lihood of concurrence. For example, if
should be considered in children
Americans may have higher A1C levels the A1C is 7.0% and a repeat result is
and adolescents who are over-
than non-Hispanic whites despite simi- 6.8%, the diagnosis of diabetes is con-
weight or obese and who have
lar fasting and postglucose load glucose firmed. If two different tests (such as
two or more additional risk factors
levels. A recent epidemiological study A1C and FPG) are both above the diagnos-
for diabetes. E
found that, when matched for FPG, tic threshold, this also confirms the diag-
African Americans (with and without di- nosis. On the other hand, if a patient has
abetes) had higher A1C levels than non- discordant results from two different Description
Hispanic whites, but also had higher levels tests, then the test result that is above In 1997 and 2003, the Expert Commit-
of fructosamine and glycated albumin the diagnostic cut point should be re- tee on Diagnosis and Classification of
and lower levels of 1,5-anhydroglucitol, peated. The diagnosis is made on the ba- Diabetes Mellitus (10,11) recognized a
suggesting that their glycemic burden sis of the confirmed test. For example, if a group of individuals whose glucose lev-
(particularly postprandially) may be patient meets the diabetes criterion of els did not meet the criteria for diabetes
higher (8). the A1C (two results $6.5%), but not but were too high to be consideredYou can also read
