IN DIABETES—2022

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ISSN 0149-5992

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—2022

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VOLUME 45 | SUPPLEMENT 1 | PAGES S1–S264

THE JOURNAL OF CLINICAL AND APPLIED RESEARCH AND EDUCATION VOLUME 45 | SUPPLEMENT 1

WWW.DIABETES.ORG/DIABETESCARE JANUARY 2022

JANUARY 2022

©AmericanDiabetesAssociation

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January 2022 Volume 45, 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 Vanita R. Aroda, MD George Bakris, MD

Lawrence Blonde, MD, FACP Andrew J.M. Boulton, MD Jessica R. Castle, MD

Linda A. DiMeglio, MA, MD, MPH Linda Gonder-Frederick, PhD Frank B. Hu, MD, MPH, PhD Steven E. Kahn, MB, ChB Sanjay Kaul, MD, FACC, FAHA Robert G. Moses, MD Stephen S. Rich, PhD Julio Rosenstock, MD Elizabeth Selvin, PhD, MPH Adrian Vella, MD

Judith Wylie-Rosett, EdD, RD

AMERICAN DIABETES ASSOCIATION OFFICERS CHAIR OF THE BOARD

John Schlosser

PRESIDENT, MEDICINE & SCIENCE

Ruth Weinstock, MD, PhD

PRESIDENT, HEALTH CARE &

EDUCATION

Cynthia Mu~noz, PhD, MPH

SECRETARY/TREASURER

Christopher Ralston, JD

CHAIR OF THE BOARD-ELECT

Glen Tullman

PRESIDENT-ELECT, MEDICINE & SCIENCE

Guillermo Umpierrez, MD, CDE, FACP, FACE

PRESIDENT-ELECT, HEALTH CARE &

EDUCATION

Otis Kirksey, PharmD, RPh, CDE, BC-ADM

SECRETARY/TREASURER-ELECT

Marshall Case

CHIEF SCIENTIFIC & MEDICAL OFFICER

Robert A. Gabbay, MD, PhD EDITORIAL BOARD

Fida Bacha, MD

Katharine Barnard-Kelly, PhD Ananda Basu, MD, FRCP Tadej Battelino, MD, PhD Petter Bjornstad, MD

Fiona Bragg, BSc, MBChB, MRCP, MSc, DPhil, FFPH

John B. Buse, MD, PhD

Mark Emmanuel Cooper, MB BS, PhD Matthew J. Crowley, MD, MHS J. Hans DeVries, MD, PhD Kimberly A. Driscoll, PhD Kathleen M. Dungan, MD, MPH Hertzel C. Gerstein, MD, MSc,

FRCOC

Jessica Lee Harding, PhD Stewart B. Harris, CM, MD, MPH,

FCFP, FACPM

Byron J. Hoogwerf, MD, FACP, FACE Sarah S. Jaser, PhD

M. Sue Kirkman, MD Richard David Graham Leslie,

MD, FRCP, FAoP

John J.V. McMurray, MD, FRCP, FESC, FACC, FAHA, FRSE, FMedSci Mark E. Molitch, MD

Helen R. Murphy, MBBChBAO, FRACP, MD

Katherine Ogurtsova, PhD Bruce A. Perkins, MD, MPH

Casey M. Rebholz, PhD, MS, MNSP, MPH Maria Jose Redondo, MD, PhD, MPH Peter Rossing, MD, DMSc

Desmond Schatz, MD Guntram Schernthaner, MD Jonathan Shaw, MD, FRCP, FRACP,

FAAHMS

Jay M. Sosenko, MD, MS Samy Suissa, PhD Giovanni Targher, MD Kristina M. Utzschneider, MD Daniel H. van Raalte, MD, PhD Joseph I. Wolsdorf, MB, BCh Daisuke Yabe, MD, PhD Sophia Zoungas, MBBS (Hons),

PhD, FRACP

The mission of the American Diabetes Association is to prevent and cure diabetes and to improve

the lives of all people affected by diabetes.

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AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS ASSOCIATE PUBLISHER,

SCHOLARLY JOURNALS

Christian S. Kohler

EDITORIAL OFFICE DIRECTOR

Lyn Reynolds

PEER REVIEW MANAGER

Shannon Potts

ASSOCIATE MANAGER, PEER REVIEW

Larissa M. Pouch

DIRECTOR, SCHOLARLY JOURNALS

Heather Norton Blackburn

ASSOCIATE DIRECTOR, SCHOLARLY JOURNALS

Keang Hok

TECHNICAL EDITOR

Theresa M. Cooper

PRODUCTION COORDINATOR

Saleha Malik

DIRECTOR, MEMBERSHIP/SUBSCRIPTION SERVICES

Donald Crowl

SENIOR ADVERTISING MANAGER

Julie DeVoss Graff jgraff@diabetes.org (703) 299-5511

SENIOR MANAGER, BILLING & COLLECTIONS

Josh Flores

jflores@diabetes.org (703) 549-1500, ext. 2110

PHARMACEUTICAL & DEVICE PRINT ADVERTISING

Lisa Morton

Senior Account Manager lmorton@diabetes.org (312) 346-1805, ext. 6571

PHARMACEUTICAL & DEVICE DIGITAL ADVERTISING

eHealthcare Solutions R.J. Lewis

President and CEO rlewis@ehsmail.com (609) 882-8887, ext. 101 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 © 2021 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 Arlington, VA, and additional mailing offices.

PRINT ISSN 0149-5992 ONLINE ISSN 1935-5548 PRINTED IN THE USA

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January 2022 Volume 45, Supplement 1

S1 Introduction

S3 Professional Practice Committee

S4 Summary of Revisions

S8 1. Improving Care and Promoting Health in Populations

Diabetes and Population Health Tailoring Treatment for Social Context S17 2. Classification and Diagnosis of Diabetes

Classification

Diagnostic Tests for Diabetes Type 1 Diabetes

Prediabetes and Type 2 Diabetes Cystic Fibrosis–Related Diabetes Posttransplantation Diabetes Mellitus Monogenic Diabetes Syndromes Pancreatic Diabetes or Diabetes in the

Context of Disease of the Exocrine Pancreas Gestational Diabetes Mellitus

S39 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities

Lifestyle Behavior Change for Diabetes Prevention Pharmacologic Interventions

Prevention of Vascular Disease and Mortality Patient-Centered Care Goals

S46 4. Comprehensive Medical Evaluation and Assessment of Comorbidities

Patient-Centered Collaborative Care Comprehensive Medical Evaluation Immunizations

Assessment of Comorbidities

S60 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes

Diabetes Self-management Education and Support Medical Nutrition Therapy

Physical Activity

Smoking Cessation: Tobacco and e-Cigarettes Psychosocial Issues

S83 6. Glycemic Targets

Assessment of Glycemic Control Glycemic Goals

Hypoglycemia Intercurrent Illness S97 7. Diabetes Technology

General Device Principles Blood Glucose Monitoring

Continuous Glucose Monitoring Devices Insulin Delivery

S113 8. Obesity and Weight Management for the Prevention and Treatment of Type 2 Diabetes

Assessment

Diet, Physical Activity, and Behavioral Therapy Pharmacotherapy

Medical Devices for Weight Loss Metabolic Surgery

S125 9. Pharmacologic Approaches to Glycemic Treatment Pharmacologic Therapy for Adults With Type 1 Diabetes Surgical Treatment for Type 1 Diabetes

Pharmacologic Therapy for Adults With Type 2 Diabetes S144 10. Cardiovascular Disease and Risk Management

The Risk Calculator

Hypertension/Blood Pressure Control Lipid Management

Statin Treatment Antiplatelet Agents Cardiovascular Disease

S175 11. Chronic Kidney Disease and Risk Management Chronic Kidney Disease

Epidemiology of Diabetes and Chronic Kidney Disease Assessment of Albuminuria and Estimated Glomerular

Filtration Rate

Diagnosis of Diabetic Kidney Disease Staging of Chronic Kidney Disease Acute Kidney Injury

Surveillance Interventions

S185 12. Retinopathy, Neuropathy, and Foot Care Diabetic Retinopathy

Neuropathy Foot Care S195 13. Older Adults

Neurocognitive Function Hypoglycemia

Treatment Goals Lifestyle Management Pharmacologic Therapy

Special Considerations for Older Adults With Type 1 Diabetes

Treatment in Skilled Nursing Facilities and Nursing Homes

End-of-Life Care

S208 14. Children and Adolescents Type 1 Diabetes

Type 2 Diabetes

Transition From Pediatric to Adult Care S232 15. Management of Diabetes in Pregnancy

Diabetes in Pregnancy Preconception Counseling Glycemic Targets in Pregnancy

Management of Gestational Diabetes Mellitus Management of Preexisting Type 1 Diabetes

and Type 2 Diabetes in Pregnancy Preeclampsia and Aspirin

Pregnancy and Drug Considerations Postpartum Care

S244 16. Diabetes Care in the Hospital Hospital Care Delivery Standards Glycemic Targets in Hospitalized Patients Bedside Blood Glucose Monitoring

Glucose-Lowering Treatment in Hospitalized Patients Hypoglycemia

Standards of Medical Care in Diabetes—2022

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Medical Nutrition Therapy in the Hospital Self-management in the Hospital Standards for Special Situations

Transition From the Hospital to the Ambulatory Setting

Preventing Admissions and Readmissions

S254 17. Diabetes Advocacy Advocacy Statements S256 Disclosures

S259 Index This issue is freely accessible online at https://diabetesjournals.org/care/issue/45/Supplement_1.

Keep up with the latest information for Diabetes Care and other ADA titles via Facebook (/ADAPublications) and Twitter (@ADA_Pubs).

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Introduction: Standards of

Medical Care in Diabetes—2022

Diabetes Care 2022;45(Suppl. 1):S1–S2 | https://doi.org/10.2337/dc22-SINT

American Diabetes Association

Diabetes is a complex, chronic illness requiring continuous medical care with multifactorial risk-reduction strategies beyond glycemic control. Ongoing dia- betes self-management education and support are critical to preventing acute complications 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 (ADA)“Standards of Medical Care in Dia- betes,” referred to as the Standards of Care, is intended to provide clinicians, researchers, policy makers, and other interested individuals with the compo- nents of diabetes care, general treat- ment goals, and tools to evaluate the quality of care. The Standards of Care recommendations are not intended to preclude clinical judgment and must be applied in the context of excellent clini- cal care, with adjustments for individual preferences, comorbidities, and other patient factors. For more detailed infor- mation about the management of diabe- tes, please refer to Medical Management of Type 1 Diabetes (1) and Medical Man- agement of Type 2 Diabetes (2).

The recommendations in the Stand- ards of Care include screening, diagnos- tic, and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabe- tes. Many of these interventions have also been shown to be cost-effective (3,4). As indicated, the recommenda- tions encompass care for youth (children ages birth to 11 years and adolescents

ages 12–18 years) and older adults (65 years and older).

The ADA strives to improve and update the Standards of Care to ensure that clinicians, health plans, and policy makers can continue to rely on it as the most authoritative source for current guidelines for diabetes care.

ADA STANDARDS, STATEMENTS, REPORTS, AND REVIEWS

The ADA has been actively involved in the development and dissemination of diabetes care clinical practice recommen- dations and related documents for more than 30 years. The ADA’s Standards of Medical Care is viewed as an important resource for health care professionals who care for people with diabetes.

Standards of Care The annual Standards of Care supplement to Diabetes Care contains official ADA position, is authored by the ADA, and provides all of the ADA’s current clinical practice recommendations.

To update the Standards of Care, the ADA’s Professional Practice Committee (PPC) performs an extensive clinical diabe- tes literature search, supplemented with input from ADA staff and the medical community at large. The PPC updates the Standards of Care annually and strives to include discussion of emerging clinical considerations in the text, and as evi- dence evolves, clinical guidance may be included in the recommendations. How- ever, the Standards of Care is a “living”

document, where important updates are published online should the PPC

determine that new evidence or regula- tory changes (e.g., drug approvals, label changes) merit immediate inclusion.

More information on the “living Stand- ards” can be found on the ADA’s profes- sional website DiabetesPro at professional .diabetes.org/content-page/living-standards.

The Standards of Care supersedes all previ- ous ADA position statements—and the rec- ommendations therein—on clinical topics within the purview of the Standards of Care; ADA position statements, while still containing valuable analysis, should not be considered the ADA’s current position. The Standards of Care receives annual review and approval by the ADA’s Board of Direc- tors and is reviewed by ADA’s clinical staff leadership.

ADA Statement

An ADA statement is an official ADA point of view or belief that does not contain clinical practice recommendations and may be issued on advocacy, policy, economic, or medical issues related to diabetes.

ADA statements undergo a formal review process, including a review by the appropriate ADA national commit- tee, ADA science and health care staff, and the ADA’s Board of Directors.

Consensus Report

A consensus report of a particular topic contains a comprehensive examination and is authored by an expert panel (i.e., consensus panel) and represents the panel’s collective analysis, evaluation, and opinion.

The need for a consensus report arises when clinicians, scientists, regulators,

The“Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: December 2021.

© 2021 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 https://diabetesjournals.org/journals/pages/license.

INTRODUCTION

Diabetes Care Volume 45, Supplement 1, January 2022 S1

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and/or policy makers desire guidance and/or clarity on a medical or scientific issue related to diabetes for which the evidence is contradictory, emerging, or incomplete. Consensus reports may also highlight gaps in evidence and propose areas of future research to address these gaps. A consensus report is not an ADA position but represents expert opinion only and is produced under the auspices of the ADA by invited experts.

A consensus report may be developed after an ADA Clinical Conference or Research Symposium.

Scientific Review

A scientific review is a balanced review and analysis of the literature on a scientific or medical topic related to diabetes.

A scientific review is not an ADA posi- tion and does not contain clinical prac- tice recommendations but is produced under the auspices of the ADA by invited experts. The scientific review may provide a scientific rationale for clinical practice recommendations in the Standards of Care. The category may also include task force and expert committee reports.

GRADING OF SCIENTIFIC EVIDENCE Since the ADAfirst began publishing clini- cal practice guidelines, there has been considerable 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. A 2015 analysis of the evidence cited in the Standards of Care found steady improvement in quality over the previous 10 years, with the 2014 Stand- ards of Care for thefirst time having the majority of bulleted recommendations supported byAlevel orBlevel evidence (5). A grading system (Table 1) developed by the ADA and modeled after existing methods was used to clarify and codify the evidence that forms the basis for the recommendations. All recommendations are critical to comprehensive care. ADA recommendations are assigned ratings of A,B, or C, depending on the quality of the evidence in support of the recom- mendation. Expert opinionEis a separate category for recommendations in which there is no evidence from clinical trials, clinical trials may be impractical, or there is conflicting evidence. Recommendations assigned an E level of evidence are

informed by key opinion leaders in the field of diabetes (members of the PPC) and cover important elements of clinical care. All recommendations receive a rating for the strength of the evidence and not for the strength of the recommendation.

Recommendations with A level evidence are based on large well-designed clinical trials or well-done meta-analyses. Gener- ally, these recommendations have the best chance of improving outcomes when applied to the population for which they are appropriate. Recommendations with lower levels of evidence may be equally important but are not as well supported.

Of course, published evidence is only one component of clinical decision-mak- ing. Clinicians care for patients, not pop- ulations; guidelines must always be interpreted with the individual patient in mind. Individual circumstances, such as comorbid and coexisting diseases, age, education, disability, and, above all, patients’ values and preferences, must be considered and may lead to different treatment targets and strategies. Fur- thermore, conventional evidence hierar- chies, such as the one adapted by the ADA, may miss nuances important in dia- betes care. For example, although there is excellent evidence from clinical trials supporting the importance of achieving multiple risk factor control, the optimal way to achieve this result is less clear. It is difficult to assess each component of such a complex intervention.

References

1. American Diabetes Association. Medical Man- agement of Type 1 Diabetes. 7th ed. Wang CC, Shah AC, Eds. Alexandria, VA, American Diabetes Association, 2017

2. American Diabetes Association. Medical Man- agement of Type 2 Diabetes. 8th ed. Meneghini L, Ed. Alexandria, VA, American Diabetes Associ- ation, 2020

3. Zhou X, Siegel KR, Ng BP, Jawanda S, Proia KK, Zhang X, Albright AL, Zhang P. Cost-effectiveness of diabetes prevention interventions targeting high- risk individuals and whole populations: a systematic review. Diabetes Care 2020;43:1593–1616 4. Siegel KR, Ali MK, Zhou X, Ng BP, Jawanda S, Proia K, Zhang X, Gregg EW, Albright AL, Zhang P.

Cost-effectiveness of interventions to manage diabetes: has the evidence changed since 2008?

Diabetes Care 2020;43:1557–1592

5. 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 Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes”

Level of

evidence Description

A Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including:

 Evidence from a well-conducted multicenter trial

 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:

 Evidence from a well-conducted trial at one or more institutions

 Evidence from a meta-analysis that incorporated quality ratings in the analysis B Supportive evidence from well-conducted cohort studies

 Evidence from a well-conducted prospective cohort study or registry

 Evidence from a well-conducted meta-analysis of cohort studies Supportive evidence from a well-conducted case-control study C Supportive evidence from poorly controlled or uncontrolled studies

 Evidence from randomized clinical trials with one or more major or three or more minor methodologicalflaws that could invalidate the results

 Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls)

 Evidence from case series or case reports

Conflicting evidence with the weight of evidence supporting the recommendation E Expert consensus or clinical experience

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Professional Practice Committee:

Standards of Medical Care in Diabetes—2022

Diabetes Care 2022;45(Suppl. 1):S3 | https://doi.org/10.2337/dc22-SPPC

American Diabetes Association

The Professional Practice Committee (PPC) of the American Diabetes Associa- tion (ADA) is responsible for the “Stan- dards of Medical Care in Diabetes,” referred to as the Standards of Care. The PPC is a multidisciplinary expert commit- tee comprising physicians, diabetes care and education specialists, and others who have expertise in a range of areas, including, but not limited to, adult and pediatric endocrinology, epidemiology, public health, cardiovascular risk manage- ment, microvascular complications, pre- conception and pregnancy care, weight management and diabetes prevention, and use of technology in diabetes man- agement. Appointment to the PPC is based on excellence in clinical practice and research, with attention to appropri- ate representation of members based on considerations including but not limited to demographic, geographical, work set- ting, or identity characteristics (e.g., gen- der, ethnicity, ability level, etc.). Although the primary role of the PPC members is to review and update the Standards of Care, they may also be involved in ADA statements, reports, and reviews.

All members of the PPC are required to disclose potential conflicts of interest with industry and other relevant organi- zations. These disclosures are discussed at the outset of each Standards of Care revision meeting. Members of the com- mittee, their employers, and their dis- closed conflicts of interest are listed in

“Disclosures: Standards of Medical Care in Diabetes—2022” (https://doi.org/

10.2337/dc22-SPPC). The ADA funds development of the Standards of Care

out of its general revenues and does not use industry support for this purpose.

Relevant literature was thoroughly reviewed through 1 July 2021; additionally, critical updates published through 1 August 2021 were considered. Exceptions were made for ADA-convened consensus reports, like "The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)" (https://doi.org/

10.2337/dci21-0043). Recommendations were revised based on new evidence, new considerations for standard of care practices, or, in some cases, to clarify the prior recommendations or revise wording to match the strength of the published evidence. A table linking the changes in recommendations to new evidence can be reviewed online at professional .diabetes.org/SOC. The Standards of Care is reviewed by ADA scientific and medical staff and is approved by the ADA’s Board of Directors, which includes health care professionals, scientists, and lay people.

Feedback from the larger clinical com- munity was invaluable for the annual 2021 revision of the Standards of Care.

Readers who wish to comment on the 2022 Standards of Care are invited to do so at professional.diabetes.org/SOC.

The PPC thanks the following individu- als who provided their expertise in reviewing and/or consulting with the committee: Kristine Bell, APD, CDE, PhD;

Lee-Shing Chang, MD; Alison B. Evert, MS, RDN, CDCES; Deborah Greenwood, PhD, RN, BC-ADM, CDCES, FADCES; Joy Hayes, MS, RDN, CDCES; Helen Lawler, MD;

Joshua J. Neumiller, PharmD, CDCES, FADCES, FASCP; Naushira Pandya, MD, CMD, FACP; Mary Elizabeth Patti, MD, FACP, FTOS; Marian Rewers, MD; Alissa Segal, PharmD, RPh, CDE, CDTC, FCCP;

David Simmons, BA, MBBS, MA, MD, FRACP, FRCP; Christopher Still, DO, FACP, FTOS; Jennifer Sun, MD; Erika F. Werner, MD, MS; and Jennifer Wyckoff, MD.

Members of the PPC

Boris Draznin, MD, PhD (Chair) Vanita R. Aroda, MD

George Bakris, MD

Gretchen Benson, RDN, LD, CDCES Florence M. Brown, MD

RaShaye Freeman, DNP, FNP-BC, CDCES, ADM-BC

Jennifer Green, MD

Elbert Huang, MD, MPH, FACP

Diana Isaacs, PharmD, BCPS, BC-ADM, CDCES Scott Kahan, MD, MPH

Jose Leon, MD, MPH Sarah K. Lyons, MD Anne L. Peters, MD Priya Prahalad, MD, PhD Jane E.B. Reusch, MD

Deborah Young-Hyman, PhD, CDCES American College of Cardiology Designated Representatives (Section 10)

Sandeep Das, MD, MPH, FACC Mikhail Kosiborod, MD, FACC ADA Staff

Mindy Saraco, MHA (corresponding author: msaraco@diabetes.org) Malaika I. Hill, MA

Robert A. Gabbay, MD, PhD Nuha Ali El Sayed, MD, MMSc

© 2021 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 https://diabetesjournals.org/journals/pages/license.

PROFESSIONALPRACTICECOMMITTEE

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Summary of Revisions: Standards of Medical Care in Diabetes—2022

Diabetes Care 2022;45(Suppl. 1):S4–S7 | https://doi.org/10.2337/dc22-SREV

American Diabetes Association Professional Practice Committee*

GENERAL CHANGES

The field of diabetes care is rapidly changing as new research, technology, and treatments that can improve the health and well-being of people with dia- betes continue to emerge. With annual updates since 1989, the American Diabe- tes Association (ADA) has long been a leader in producing guidelines that cap- ture the most current state of thefield.

Although levels of evidence for several recommendations have been updated, these changes are not outlined below where the clinical recommendation has remained the same. That is, changes in evidence level from, for example,E toC are not noted below. The 2022 Stand- ards of Care contains, in addition to many minor changes that clarify recom- mendations or reflect new evidence, the following more substantive revisions.

SECTION CHANGES

Section 1. Improving Care and Promoting Health in Populations (https://doi.org/10.2337/dc22-S001) Additional information has been included on online platforms to support behavior change and well-being. The renamed

“Cost Considerations for Medication-Tak- ing Behaviors” subsection has been expanded to include more discussion about costs of medications and treat- ment goals.

The concept of health numeracy and its role in diabetes prevention and man- agement was added to the newly

named“Health Literacy and Numeracy”

subsection.

The community health workers con- tent was expanded.

Section 2. Classification and Diagnosis of Diabetes

(https://doi.org/10.2337/dc22-S002) A recommendation about adequate car- bohydrate intake prior to oral glucose tolerance testing as a screen for diabe- tes was added, with supportive referen- ces added to the text (Recommendations 2.4 and 2.12).

The discussion regarding use of point- of-care A1C assays for the diagnosis of diabetes has been revised.

More information has been added to the“Race/Ethnicity/Hemoglobinopathies”

subsection.

The“Type 1 Diabetes” subsection and the recommendations within have been updated based on the publication of

“The Management of Type 1 Diabetes in Adults. A Consensus Report by the Amer- ican Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)” (https://doi.org/10.2337/

dci21-0043).

Under“Classification,” immune check- point inhibitors have been added as a cause of medication-induced diabetes.

Additional evidence and discussion have been added to the subsection“Screening for Type 1 Diabetes Risk.”

Recommendation 2.9 has been revised to recommend that, for all people,

screening for prediabetes and diabetes should begin at age 35 years.

Recommendation 2.24 regarding genetic testing for those who do not have typical characteristics of type 1 or type 2 diabetes has been revised based on the publication of“The Management of Type 1 Diabetes in Adults. A Consen- sus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)” (https://doi.org/10.2337/dci21- 0043).

The gestational diabetes mellitus rec- ommendations have been revised with changes made regarding preconception and early pregnancy screening for diabe- tes and abnormal glucose metabolism, with supporting evidence added to the text.

Section 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities

(https://doi.org/10.2337/dc22-S003) The title has been changed to “Pre- vention or Delay of Type 2 Diabetes and Associated Comorbidities.”

Recommendation 3.1 has been modi- fied to better individualize monitoring for the development of type 2 diabetes in those with prediabetes.

Adults with overweight/obesity are recommended to be referred to an intensive lifestyle behavior change pro- gram (Recommendation 3.2).

Additional considerations have been added to the recommendation regarding

*A complete list of members of the American Diabetes Association Professional Practice Committee can be found at https://doi.org/10.2337/

dc22-SPPC.

© 2021 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 https://diabetesjournals.org/journals/pages/license.

SUMMARYOFREVISIONS

S4 Diabetes Care Volume 45, Supplement 1, January 2022

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metformin therapy (Recommendation 3.6).

More discussion was added on vitamin D supplementation in the“Pharmacologic Interventions” subsection.

There is a new subsection and recom- mendation on patient-centered care aimed at weight loss or prevention of weight gain, minimizing progression of hyperglycemia, and attention to cardio- vascular risk and associated comorbidi- ties.

Section 4. Comprehensive Medical Evaluation and Assessment of Comorbidities

(https://doi.org/10.2337/dc22-S004) The“Immunizations” subsection has been revised, and more information and evi- dence on the influenza vaccine for people with diabetes and cardiovascular disease has been added to the“Influenza” sub- section. Within this subsection, coronavi- rus disease 2019 (COVID-19) vaccination information has been added based on evolving evidence.

Table 4.6, management of patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), andTable 4.7, summary of pub- lished NAFLD guidelines, reproduced from

“Preparing for the NASH Epidemic: A Call to Action” (https://doi.org/10.2337/dci21- 0020), provide more information on how to manage these diseases. Developed fol- lowing an American Gastroenterological Association conference on the burden, screening, risk stratification, diagnosis, and management of individuals with NAFLD, the Call to Action informed other revisions to the“Nonalcoholic Fatty Liver Disease” subsection.

Section 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes

(https://doi.org/10.2337/dc22-S005) Recommendation 5.5 has been added to the “Diabetes Self-Management Education and Support” subsection to address digital coaching and digital self- management interviews as effective methods of education and support.

In the “Carbohydrates” subsection, more emphasis has been placed on the quality of carbohydrates selected. In Rec- ommendation 5.15, afiber goal has been added for additional clarity. Evidence on consumption of mixed meals, insulin

dosing, and impact on glycemia has also been added to this subsection.

A new subsection on cognitive capac- ity/impairment has been added, with recommendations for monitoring (Recom- mendation 5.51) and referral (Recom- mendation 5.52) for formal assessment, and a discussion of the evidence regard- ing cognitive impairment and diabetes.

Section 6. Glycemic Targets (https://doi.org/10.2337/dc22-S006) Time in range has been more fully incor- porated into the“Glycemic Assessment”

subsection.

Time in range thresholds were removed from Recommendation 6.4, and the reader is directed toTable 6.2 for those values.

Glucose variability and the associa- tion of hypoglycemia was added to the

“Hypoglycemia” subsection, as well as information on hypoglycemia preven- tion, including the Blood Glucose Awareness Training, Dose Adjusted for Normal Eating (DAFNE), and DAFNEplus programs.

Section 7. Diabetes Technology (https://doi.org/10.2337/dc22-S007) General recommendations on the selec- tion of technology based on individual and caregiver preferences (Recommenda- tion 7.1), ongoing education on use of devices (Recommendation 7.2), contin- ued access to devices across payers (Rec- ommendation 7.3), support of students using devices in school settings (Recom- mendation 7.4), and early initiation of technology (Recommendation 7.5) now introduce the technology section, when previously these concepts were distrib- uted throughout the section.

“Self-monitoring of blood glucose (SMBG)” was replaced with the more commonly used “blood glucose moni- toring (BGM)” throughout, and more information based on the U.S. Food and Drug Administration recommendation regarding when an individual might need access to BGM was added to the

“Blood Glucose Monitoring” subsection.

The recommendations regarding use of continuous glucose monitoring (CGM) were divided between adults (Recom- mendations 7.11 and 7.12) and youth (Recommendations 7.13 and 7.14), and the recommendation regarding periodic use of CGM or the use of professional CGM has been simplified (Recommen-

dation 7.17). Frequency of sensor use has also been added to the text of the

“Continuous Glucose Monitoring Devices”

subsection, as well as a restructuring of the text in this section based on study design.

“Smart pens” are now referred to as

“connected insulin pens,” and more dis- cussion and evidence has been added to the insulin pens content.

The discussion of automated insulin delivery (AID) systems has been com- bined with the insulin pumps subsection and is separate from the“Do-It-Yourself Closed-Loop Systems” subsection.

Recommendation 7.29 has been modified to include outpatient proce- dures and the consideration that people should be allowed continued use of dia- betes devices during inpatient or outpa- tient procedures when they can safely use them and supervision is available.

Section 8. Obesity and Weight Management for the Prevention and Treatment of Type 2 Diabetes (https://doi.org/10.2337/dc22-S008) The title has been changed to“Obesity and Weight Management for the Pre- vention and Treatment of Type 2 Diabetes.”

Evidence has been added regarding the importance of addressing obesity, as both obesity and diabetes increase risk for more severe COVID-19 infections.

The concept of weight distribution and weight gain pattern and trajectory, in addition to weight and BMI, has been added to the“Assessment” subsection.

Recommendation 8.12 and its associ- ated text discussion added to the“Diet, Physical Activity, and Behavioral Therapy” subsection address the lack of clear evi- dence that dietary supplements are effective for weight loss.

The“Medical Devices for Weight Loss”

subsection has been revised to include more information on a newly approved oral hydrogel.

Recommendation 8.21 has been revised to include behavioral support and routine monitoring of metabolic status.

A new recommendation (Recommen- dation 8.22) and discussion on postbari- atric hypoglycemia, its causes, diagnosis, and management have been added.

Table 8.2, medications approved by the FDA for the treatment of obesity, has been updated to include semaglutide.

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Section 9. Pharmacologic

Approaches to Glycemic Treatment (https://doi.org/10.2337/dc22-S009) Recommendation 9.3 has been revised to include fat and protein content, in addition to carbohydrates, as part of education on matching mealtime insulin dosing.

Fig. 9.1, “Choices of insulin regimens in people with type 1 diabetes,” Fig.

9.2, “Simplified overview of indications forb-cell replacement therapy in people with type 1 diabetes,” and Table 9.1,

“Examples of subcutaneous insulin regi- mens,” from “The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Asso- ciation (ADA) and the European Associa- tion for the Study of Diabetes (EASD)” (https://doi.org/10.2337/dci21-0043), have been added to the“Pharmacologic Therapy for Adults with Type 1 Diabetes” subsection.

Table 9.2 has been updated.

Recommendation 9.4 has been revised and is now two recommendations (Rec- ommendations 9.4a and 9.4b) on first- line therapies and initial therapies, all based on comorbidities, patient-centered treatment factors, and management needs.

Recommendation 9.5 has been up- dated with other considerations for the continuation of metformin therapy after patients have been initiated on insulin.

A new recommendation has been added regarding the use of insulin and combination therapy with a glucagon- like peptide 1 (GLP-1) receptor agonist for greater efficacy and durability (Rec- ommendation 9.11).

The section now concludes with an overview of changes made toFig. 9.3,

“Pharmacologic treatment of hypergly- cemia in adults with type 2 diabetes,” to reconcile emerging evidence and support harmonization of guidelines recognizing alternative initial treatment approaches to metformin as acceptable, depending on comorbidities, patient- centered treatment factors, and glycemic and comorbidity management needs. The principle of medication incorporation is emphasized throughout Fig. 9.3—not all treatment intensifica- tion results in sequential add-on ther- apy, and instead may involve switching therapy or weaning current therapy to accommodate therapeutic changes.

Section 10. Cardiovascular Disease and Risk Management

(https://doi.org/10.2337/dc22-S010) This section is endorsed for the fourth consecutive year by the American Col- lege of Cardiology.

A new figure (Fig. 10.1) has been added to depict the recommended com- prehensive approach to the reduction in risk of diabetes-related complications.

Recommendation 10.1 on screening and diagnosis of blood pressure has been revised to include diagnosis of hypertension at a single health care visit for individuals with blood pressure mea- suring$180/110 mmHg and cardiovas- cular disease.

More information on low diastolic blood pressure and blood pressure management has been added to the

“Individualization of Treatment Targets”

subsection under “Hypertension/Blood Pressure Control.”

In the “Treatment Strategies: Lifestyle Interventions” subsection under “Hyper- tension/Blood Pressure Control,” discus- sion has been added on the use of inter- net or mobile-based digital platforms to reinforce healthy behaviors and their abil- ity to enhance the efficacy of medical therapy for hypertension.

More information on use of ACE inhib- itors and angiotensin receptor blocker (ARB) therapy for those with kidney function decline has been added to the

“Pharmacologic Interventions” subsec- tion under“Hypertension/Blood Pressure Control.”

Ezetimibe being preferential due to its lower cost has been removed from Recommendation 10.24.

More discussion was added on use of evolocumab therapy and reduction in all strokes and ischemic stroke.

A new subsection on statins and bempedoic acid has been added.

A discussion of the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effec- tiveness) trial has been added to the

“Aspirin Dosing” subsection.

A discussion of the TWILIGHT (Tica- grelor With Aspirin or Alone in High- Risk Patients After Coronary Interven- tion) trial has been added to the

“Indications for P2Y12 Receptor Antago- nist Use” subsection.

Recommendation 10.42c has been added to the “Cardiovascular Disease:

Treatment” subsection, providing guidance

for patients with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors for ASCVD on the use of combined ther- apy with a sodium–glucose cotransporter 2 (SGLT2) inhibitor with demonstrated car- diovascular benefit and a GLP-1 receptor agonist with demonstrated cardiovascular benefit.

A discussion of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial, the Effect of Sotagliflozin on Car- diovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial, and the Effect of Efpeglenatide on Cardiovascu- lar Outcomes (AMPLITUDE-O) have been added, in addition to the results of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial, the Evaluation of Ertu- gliflozin Efficacy and Safety Cardiovascu- lar Outcomes Trial (VERTIS CV), and the Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impair- ment Who Are at Cardiovascular Risk (SCORED) trial, which were added as a Living Standards update in June 2021.

Table 10.3C has been updated.

A new subsection,“Clinical Approach,”

now concludes this section on risk reduc- tion with SGLT2 inhibitors or GLP-1 recep- tor agonist therapy. Fig. 10.3 has been reproduced from the ADA-endorsed American College of Cardiology “2020 Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients with Type 2 Diabetes” (https://doi.org/10.1016/j.jacc .2020.05.037) and outlines the approach to risk reduction with SGLT2 inhibitor or GLP-1 receptor agonist therapy in conjunction with other traditional, guideline-based preventive medical therapies for blood pressure as well as lipid, glycemic, and antiplatelet therapy.

Section 11. Chronic Kidney Disease and Risk Management

(https://doi.org/10.2337/dc22-S011) Formerly, Section 11, “Microvascular Complications and Foot Care,” con- tained content on chronic kidney dis- ease, retinopathy, neuropathy, and foot care. This section has now been divided into two sections: Section 11, “Chronic Kidney Disease and Risk Management” (https://doi.org/10.2337/dc22-S011),

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and Section 12, “Retinopathy, Neu- ropathy, and Foot Care” (https://doi .org/10.2337/dc22-S012).

Recommendation 11.3a has been revised to include lower glomularfiltra- tion rates and lower urinary albumin as indicators for use of SGLT2 inhibitors to reduce chronic kidney disease (CKD) progression and cardiovascular events.

Recommendation 11.3c has also been revised to include therapy options (nonsteroidal mineralocorticoid receptor antagonist [finerenone]), and a new rec- ommendation has been added (Recom- mendation 11.3d) regarding reduction of urinary albumin to slow CKD progression.

The concept of blood pressure vari- ability has been added to Recommenda- tion 11.4.

More discussion has been added to the “Acute Kidney Injury” subsection regarding use of ACE inhibitors or ARBs.

Section 12. Retinopathy, Neuropathy, and Foot Care

(https://doi.org/10.2337/dc22-S012) Formerly, Section 11, “Microvascular Complications and Foot Care,” contained content on chronic kidney disease, reti- nopathy, neuropathy, and foot care. This section has now been divided into two sections: Section 11,“Chronic Kidney Dis- ease and Risk Management” (https://doi .org/10.2337/dc22-S011), and Section 12,

“Retinopathy, Neuropathy, and Foot Care”

(https://doi.org/10.2337/dc22-S012).

More discussion was added to the

“Diabetic Retinopathy” subsection re- garding use of GLP-1 receptor agonists and retinopathy.

Recommendation 12.11 was updated to indicate that intravitreous injections of anti–vascular endothelial growth fac- tor are a reasonable alternative to tradi- tional panretinal laser photocoagulation for some patients with proliferative dia- betic retinopathy and also reduce the risk of vision loss in these patients.

Recommendation 12.12 was also updated to recommend intravitreous injections of anti–vascular endothelial growth factor asfirst-line treatment for most eyes with diabetic macular edema that involves the foveal center and impairs visions acuity.

A new recommendation (Recommen- dation 12.13) was added on macular

focal/grid photocoagulation and intravi- treal injections of corticosteroid.

Section 13. Older Adults

(https://doi.org/10.2337/dc22-S013) In the“Hypoglycemia” subsection, glyce- mic variability and older adults with phys- ical or cognitive limitations was added to the discussion of use of CGM.

The upper threshold of 8.5% (69 mmol/mol) was removed from the exam- ple of less stringent goals for those with multiple coexisting chronic illnesses, cog- nitive impairment, or functional depen- dence in Recommendation 13.6.

More discussion was added on classi- fication of older adults in the “Patients With Complications and Reduced Func- tionality” subsection.

The benefits of a structured exercise program (as in the Lifestyle Interventions and Independence for Elders [LIFE] Study) was incorporated into the“Lifestyle Man- agement” subsection.

More discussion of overtreatment was added to the “Pharmacologic Therapy”

subsection, as was the consideration that for those taking metformin long term, monitoring vitamin B12 deficiency should be considered. The insulin therapy discus- sion was also updated with more infor- mation on avoidance of hypoglycemia.

Section 14. Children and Adolescents (https://doi.org/10.2337/dc22-S014) Table 14.1A and Table 14.1B have been newly created and provide an overview of the recommendations for screening and treatment of complications and related conditions in pediatric type 1 diabetes (Table 14.1A) and type 2 dia- betes (Table 14.1B).

The“Diabetes Self-Management Edu- cation and Support” subsection now discusses adult caregivers as critical to diabetes self-management in youth, and how they should be engaged to ensure there is not a premature transfer of responsibility for self-management to the youth.

Recommendation 14.7 has been simplified.

Recommendations in the renamed

“Glycemic Monitoring, Insulin Delivery, and Targets” subsection (Recommenda- tions 14.18–14.27) have been reorganized and revised to better align with

recommendations in Section 7,“Diabetes Technology” (https://doi.org/10.2337/

dc22-S007).

The recommendations in the type 1 diabetes “Management of Cardiovascu- lar Risk Factors” subsection (Recom- mendations 14.34–14.42) have been revised to include more information on timing of screening and treatment and updates to indicators for screening and treatment.

Throughout the section, more has been added regarding reproductive counseling in female youth consider- ing ACE inhibitors and ARBs.

A new recommendation (Recommen- dation 14.49) was added to the“Retino- pathy” subsection for type 1 diabetes regarding retinal photography.

A new recommendation (Recommen- dation 14.61) has been added on the use of CGM for youth with type 2 diabe- tes on multiple daily injections or contin- uous subcutaneous insulin infusion.

The recommendations for hyperten- sion screening and management (Recom- mendations 14.77–14.80) for type 2 diabetes have been revised.

Fig. 14.1 has been updated.

Section 15. Management of Diabetes in Pregnancy

(https://doi.org/10.2337/dc22-S015) A new recommendation (Recommenda- tion 15.16) and discussion of the evidence on telehealth visits for pregnant women with gestational diabetes mellitus has been added to the“Management of Ges- tational Diabetes Mellitus” subsection.

A new subsection on“Physical Activity”

has been added.

Additional discussion was added regarding insulin as the preferred treat- ment for type 2 diabetes in pregnancy.

Section 16. Diabetes Care in the Hospital

(https://doi.org/10.2337/dc22-S016) Additional information has been added on the use of CGM during the COVID-19 pandemic to minimize contact between health care providers and patients, espe- cially those in the intensive care unit.

Section 17. Diabetes Advocacy (https://doi.org/10.2337/dc22-S017) No changes have been made to this section.

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1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes—2022

Diabetes Care 2022;45(Suppl. 1):S8–S16 | https://doi.org/10.2337/dc22-S001

American Diabetes Association Professional Practice Committee*

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

includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guide- lines, and tools to evaluate quality of care. Members of the ADA Professional Prac- tice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/

dc22-SPPC), 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 rec- ommendations, please refer to the Standards of Care Introduction (https://doi .org/10.2337/dc22-SINT). 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, include social community support, and are made collaboratively with patients based on individual preferences, prognoses, comorbidities, and informedfinancial considerations.B

1.2 Align approaches to diabetes management with the Chronic Care Model.

This model emphasizes person-centered team care, integrated long-term treatment approaches to diabetes and comorbidities, and ongoing collab- orative communication and goal setting between all team members.A 1.3 Care systems should facilitate team-based care, including those knowl-

edgeable and experienced in diabetes management as part of the team, and utilization of patient registries, decision support tools, and commu- nity involvement to meet patient needs.B

1.4 Assess diabetes health care maintenance (see Table 4.1) using reliable and relevant data metrics to improve processes of care and health out- comes, with attention to care costs.B

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 factors (exercise, diet, A1C, etc.) (1). Clinical practice recommendations for health care providers are tools that can ultimately improve health across

*A complete list of members of the American Diabetes Association Professional Practice Committee can be found at https://doi.org/

10.2337/dc22-SPPC.

Suggested citation: American Diabetes Asso- ciation Professional Practice Committee. 1.

Improving care and promoting health in populations: Standards of Medical Care in Diabetes—2022. Diabetes Care 2022;45(Suppl.

1):S8–S16

© 2021 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 https://diabetesjournals.org/journals/pages/

license.

1.IMPROVINGCAREANDPROMOTINGHEALTH

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populations; however, for optimal out- comes, diabetes care must also be individualized for each patient. Thus, efforts to improve population health will require a combination of policy- level, system-level, and patient-level approaches. With such an integrated approach in mind, the American Diabe- tes Association (ADA) highlights the importance of patient-centered care, defined as care that considers individual patient comorbidities and prognoses; is respectful of and responsive to patient preferences, needs, and values; and ensures that patient values guide all clinical decisions (2). Furthermore, social determinants of health (SDOH)—often out of direct control of the individual and potentially representing lifelong risk—contribute to medical and psycho- social outcomes and must be addressed to improve all health outcomes (3). Clin- ical 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 clini- cian makes treatment recommendations for a patient who may not meet the eli- gibility criteria used in the studies on which guidelines are based. Recognizing that one size does notfit all, the stand- ards presented here provide guidance for when and how to adapt recommen- dations for an individual. This section provides guidance for providers as well as health systems and policy makers.

Care Delivery Systems

The proportion of patients with diabe- tes who achieve recommended A1C, blood pressure, and LDL cholesterol lev- els has fluctuated in recent years (4).

Glycemic control and control of choles- terol through dietary intake remain challenging. In 2013–2016, 64% of adults with diagnosed diabetes met individualized A1C target levels, 70%

achieved recommended blood pressure control, 57% met the LDL cholesterol target level, and 85% were nonsmokers (4). Only 23% met targets for glycemic, blood pressure, and LDL cholesterol measures while also avoiding smoking (4). The mean A1C nationally among people with diabetes increased slightly from 7.3% in 2005–2008 to 7.5% in 2013–2016 based on the National Health and Nutrition Examination

Survey (NHANES), with younger adults, women, and non-Hispanic Black individ- uals less likely to meet treatment targets (4). Certain segments of the population, such as young adults and patients with complex comorbidities, financial or other social hardships, and/

or limited English proficiency, face par- ticular challenges to goal-based care (5–7). Even after adjusting for these patient factors, the persistent variability in the quality of diabetes care across providers and practice settings indicates that substantial system-level improve- ments are still needed.

Diabetes poses a significant financial burden to individuals and society. It is estimated that the annual cost of diag- nosed diabetes in the U.S. in 2017 was

$327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity. After adjusting for inflation, the economic costs of dia- betes increased by 26% from 2012 to 2017 (8). This is attributed to the increased prevalence of diabetes and the increased cost per person with dia- betes. Therefore, ongoing population health strategies are needed in order to reduce costs and provide optimized care.

Chronic Care Model

Numerous interventions to improve adherence to the recommended stand- ards have been implemented. However, a major barrier to optimal care is a delivery system that is often frag- mented, lacks clinical information capa- bilities, duplicates services, and is poorly designed for the coordinated delivery of chronic care. The Chronic Care Model (CCM) takes these factors into consideration and is an effective framework for improving the quality of diabetes care (9).

Six Core Elements.The CCM includes six core elements to optimize the care of patients with chronic disease:

1. Delivery system design (moving from a reactive to a proactive care delivery system where planned visits are coordinated through a team- based approach)

2. Self-management support

3. Decision support (basing care on evi- dence-based, effective care guidelines)

4. Clinical information systems (using registries that can provide patient- specific and population-based sup- port to the care team)

5. Community resources and policies (identifying or developing resources to support healthy lifestyles) 6. Health systems (to create a quality-

oriented culture)

A 5-year effectiveness study of the CCM in 53,436 primary care patients with type 2 diabetes suggested that the use of this model of care delivery reduced the cumulative incidence of diabetes-related complications and all- cause mortality (10). Patients who were enrolled in the CCM experienced a reduction in cardiovascular disease risk by 56.6%, microvascular complications by 11.9%, and mortality by 66.1% (10).

In addition, the same study suggested that health care utilization was lower in the CCM group, which resulted in health care savings of $7,294 per indi- vidual over the study period (11).

Redefining the roles of the health care delivery team and empowering patient self-management are funda- mental to the successful implementa- tion of the CCM (12). Collaborative, multidisciplinary teams are best suited to provide care for people with chronic conditions such as diabetes and to facili- tate patients’ self-management (13–15).

There are references to guide the imple- mentation of the CCM into diabetes care delivery, including opportunities and challenges (16).

Strategies for System-Level Improvement

Optimal diabetes management requires an organized, systematic approach and the involvement of a coordinated team of dedicated health care professionals working in an environment where patient- centered, high-quality care is a priority (7,17,18). While many diabetes processes of care have improved nationally in the past decade, the overall quality of care for patients with diabetes remains sub- optimal (4). Efforts to increase the qual- ity of diabetes care include providing care that is concordant with evidence- based guidelines (19); expanding the role of teams to implement more intensive disease management strategies (7,20,21);

tracking medication-taking behavior at a systems level (22); redesigning the organi- zation of the care process (23);

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References

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