Introduction and Methodology: Standards of Care in Diabetes—2023

The recommendations in the Standards of Care include screening, diagnostic, and therapeutic actions that are known or believed to favorably affect health outcomes of people with diabetes. They also cover the prevention, screening, diagnosis, and management of diabetes-associated complications and comorbidities. The recommendations encompass care throughout the lifespan, for youth (children aged birth to 11 years and adolescents aged 12–17 years), adults (aged 18–64 years), and older adults (aged ≥65 years). The recommendations cover the management of type 1 diabetes, type 2 diabetes, gestational diabetes mellitus, and other types of diabetes.

The Standards of Care does not provide comprehensive treatment plans for complications associated with diabetes, such as diabetic retinopathy or diabetic foot ulcers, but offers guidance on how and when to screen for diabetes complications, management of complications in the primary care and diabetes care settings, and referral to specialists as appropriate. Similarly, regarding the psychosocial factors often associated with diabetes and that can affect diabetes care, the Standards of Care provides guidance on how and when to screen, management in the primary care and diabetes care settings, and referral but does not provide comprehensive management plans for conditions that require specialized care, such as mental illness.

The target audience for the Standards of Care includes primary care physicians, endocrinologists, nurse practitioners, physician associates/assistants, pharmacists, dietitians, and diabetes care and education specialists. The Standards of Care also provides guidance to specialists caring for people with diabetes and its multitude of complications, such as cardiologists, nephrologists, emergency physicians, internists, pediatricians, psychologists, neurologists, ophthalmologists, and podiatrists. Additionally, these recommendations help payers, policy makers, researchers, research funding organizations, and advocacy groups to align their policies and resources and deliver optimal care for people living with diabetes.

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. The Standards of Care recommendations are not intended to preclude clinical judgment. They must be applied in the context of excellent clinical care, with adjustments for individual preferences, comorbidities, and other patient factors. For more detailed information about the management of diabetes, please refer to Medical Management of Type 1 Diabetes (1) and Medical Management of Type 2 Diabetes (2).

The Standards of Care includes discussion of evidence and clinical practice recommendations intended to optimize care for people with diabetes by assisting providers and individuals in making shared decisions about diabetes care. The recommendations are informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options.

The PPC of the ADA is responsible for the Standards of Care. The PPC is a multidisciplinary expert committee comprising physicians, nurse practitioners, pharmacists, diabetes care and education specialists, registered dietitian nutritionists, behavioral health scientists, and others who have expertise in a range of areas including but not limited to adult/pediatric endocrinology, epidemiology, public health, behavioral health, cardiovascular risk management, microvascular complications, nephrology, neurology, ophthalmology, podiatry, clinical pharmacology, preconception and pregnancy care, weight management and diabetes prevention, and use of technology in diabetes management. Appointment to the PPC is based on excellence in clinical practice and research, with attention to appropriate representation of members based on considerations including but not limited to demographic, geographic, work setting, or identity characteristics (e.g., gender, ethnicity, ability level). For the 2023 Standards of Care, as in previous years, two representatives from the American College of Cardiology (ACC) acted as ad hoc PPC members and reviewed and approved Section 10, “Cardiovascular Disease and Risk Management.” A PPC chairperson is appointed by the ADA (currently N.A.E.) for a 1-year term and oversees the committee.

Each section of the Standards of Care is reviewed annually and updated with the latest evidence-based recommendations by a PPC member designated as the section lead as well as subcommittee members. The subcommittees perform systematic literature reviews and identify and summarize the scientific evidence. An information specialist with knowledge and experience in literature searching (a librarian) is consulted as necessary. A guideline methodologist (R.R.B. for the 2023 Standards of Care) with expertise and training in evidence-based medicine and guideline development methodology oversees all methodological aspects of the development of the Standards of Care and serves as a statistical analyst.

All members of the expert panel (the PPC members, ad hoc members, and subject matter experts) and ADA staff are required to comply with the ADA policy on duality of interest, which requires disclosure of any financial, intellectual, or other interests that might be construed as constituting an actual, potential, or apparent conflict, regardless of relevancy to the guideline topic. For transparency, ADA requires full disclosure of all relationships. Full disclosure statements from all committee members are solicited and reviewed during the appointment process. Disclosures are then updated throughout the guideline development process (specifically before the start of every meeting), and disclosure statements are submitted by every Standards of Care author upon submission of the revised Standards of Care section. Members are required to disclose for a time frame that includes 1 year prior to initiation of the committee appointment process until publication of that year’s Standards of Care. Potential dualities of interest are evaluated by a designated review group and, if necessary, the Legal Affairs Division of the ADA. The duality of interest assessment is based on the relative weight of the financial relationship (i.e., the monetary amount) and the relevance of the relationship (i.e., the degree to which an independent observer might reasonably interpret an association as related to the topic or recommendation of consideration). In addition, the ADA adheres to Section 7 of the Council for Medical Specialty Societies “Code for Interactions with Companies” (3). The duality of interest review group also ensures the majority of the PPC and the PPC chair are without potential conflict relevant to the subject area. Furthermore, the PPC chair is required to remain unconflicted for 1 year after the publication of the Standards of Care. Members of the committee who disclose a potential duality of interest pertinent to any specific recommendation are prohibited from participating in discussions related to those recommendations. No expert panel members were employees of any pharmaceutical or medical device company during the development of the 2023 Standards of Care. Members of the PPC, their employers, and their disclosed potential dualities of interest are listed in the section “Disclosures: Standards of Medical Care in Diabetes—2023.” The ADA funds the development of the Standards of Care from general revenue and does not use industry support for this purpose.

The Standards of Care subcommittee for each section creates an initial list of relevant clinical questions that is reviewed and discussed by the expert panel. In consultation with a systematic review expert, each subcommittee devises and executes systematic literature searches. For the 2023 Standards of Care, PubMed, Medline, and EMBASE were searched for the time periods of 1 June 2021 to 26 July 2022. Searches are limited to studies published in English. Subcommittee members also manually search journals, reference lists of conference proceedings, and regulatory agency websites. All potentially relevant citations are then subjected to a full-text review. In consultation with the methodologist, the subcommittees prepare the evidence summaries and grading for each section of the Standards of Care. All PPC members discuss and review the evidence summaries and make revisions as appropriate. The final evidence summaries are then deliberated on by the PPC, and the recommendations that will appear in the Standards of Care are drafted.

A grading system (Table 1 ) developed by the ADA and modeled after existing methods is used to clarify and codify the evidence that forms the basis for the recommendations in the Standards of Care. All of the recommendations in the Standards of Care are critical to comprehensive care regardless of rating. ADA recommendations are assigned ratings of A, B, or C, depending on the quality of the evidence in support of the recommendation. Expert opinion E is 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 Standards of Care 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 randomized controlled trials or well-done meta-analyses of randomized controlled trials. Generally, 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-making. Clinicians care for people, not populations; guidelines must always be interpreted with the individual person in mind. Individual circumstances, such as comorbid and coexisting diseases, age, education, disability, and, above all, the values and preferences of the person with diabetes, must be considered and may lead to different treatment targets and strategies. Furthermore, conventional evidence hierarchies, such as the one adapted by the ADA, may miss nuances important in diabetes 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.

In preparation of the 2023 Standards of Care, the expert panel met for a 2-day in-person/virtual meeting in Arlington, Virginia, in July 2022, to present the evidence summaries and to develop the recommendations. All PPC members participate annually in updating the Standards of Care and approve the recommendations therein.

Public comment is particularly important in the development of clinical practice recommendations; it promotes transparency and provides key stake holders the opportunity to identify and address gaps in care. The ADA holds a year-long public comment period requesting feedback on the Standards of Care. The PPC reviews compiled feedback from the public in preparation for the annual update but considers more pressing updates throughout the year, which may be published as “living” Standards updates. Feedback from the larger clinical community and general public was invaluable for the revision of the Standards of Care—2022. Readers who wish to comment on the 2023 Standards of Care are invited to do so at professional.diabetes.org/SOC.

Feedback for the Standards of Care is also obtained from external peer reviewers. The Standards of Care is reviewed by ADA clinical leadership and scientific and medical staff and is approved by the ADA Board of Directors, which includes health care professionals, scientists, and lay people. The ACC performs an independent external peer review and the ACC Board of Directors provides endorsement of Section 10, “Cardiovascular and Metabolic Risk.” The ADA adheres to the Council for Medical Specialty Societies “Revised CMSS Principles for Clinical Practice Guideline Development” (4).

The ADA has been actively involved in developing and disseminating diabetes care clinical practice recommendations and related documents for more than 30 years. The ADA Standards of Care is an essential resource for health care professionals caring for people with diabetes. ADA Statements, Consensus Reports, and Scientific Reviews support the recommendations included in the Standards of Care.

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

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 committee, ADA clinical leadership, science and health care staff, and the ADA Board of Directors.

A consensus report on a particular topic contains a comprehensive examination, 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, 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 evidence gaps and propose future research areas 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.

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 position and does not contain clinical practice 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.

Acknowledgments. The ADA thanks the following external peer reviewers:

G. Todd Alonso, MD

Caroline M. Apovian, MD, FACP, FTOS, DABOM

Joan K. Bardsley, MBA, RN, CDCES

Sharon L. Edelstein, ScM

Robert Frykberg, DPM, MPH

Laura Hieronymus, DNP, MSEd, RN, MLDE, BC-ADM, CDCES, FADCES

Sylvia Kehlenbrink, MD

Mary Korytkowski, MD

Marie E. McDonell, MD

Felicia A. Mendelsohn Curanaj, MD

Rodica Pop-Busui, MD, PhD

Jane E. Reusch, MD

Connie M. Rhee, MD

Giulio R. Romeo, MD

Alissa R. Segal, PharmD, CDE, CDTC, FCCP

Shanti S. Serdy, MD

Viral Shah, MD

Jay H. Shubrook, DO

Ruth S. Weinstock, MD, PhD

ACC peer reviewers (Section 10):

Kim K. Birtcher, PharmD, FACC

Dave L. Dixon, PharmD, FACC

James L. Januzzi, MD

Saurabh Sharma, MD, FACC, FASE, FACP

The ADA thanks the following individuals for their support:

Abdullah Almaqhawi

Rajvinder K. Gill

Joshua Neumiller, PharmD

Anne L. Peters, MD

Sarosh Rana, MD

Guillermo Umpierrez, MD, CDCES

Mohanad R. Youssef, MD

Members of the PPC

Nuha Ali ElSayed, MD, MMSc (Chair)

Grazia Aleppo, MD

Vanita R. Aroda, MD

Raveendhara R. Bannuru, MD, PhD, FAGE (Chief Methodologist)

Florence M. Brown, MD

Dennis Bruemmer, MD, PhD

Billy S. Collins, DHSc, PA-C

Marisa E. Hilliard, PhD

Diana Isaacs, PharmD, BCPS, BCACP, CDCES, BC-ADM, FADCES, FCCP

Eric L. Johnson, MD

Scott Kahan, MD, MPH

Kamlesh Khunti, MD, PhD, FRCP, FRCGP, FMedSci

Jose Leon, MD, MPH

Sarah K. Lyons, MD

Mary Lou Perry, MS, RDN, CDCES

Priya Prahalad, MD, PhD

Richard E. Pratley, MD

Jane Jeffrie Seley, DNP, MPH, MSN, BSN, RN, GNP, BC-ADM, CDCES, CDTC, FADCES, FAAN

Robert C. Stanton, MD

Robert A. Gabbay, MD, PhD

ACC–Designated Representatives (Section 10)

Sandeep R. Das, MD, MPH, FACC

Mikhail Kosiborod, MD, FACC, FAHA

Designated Subject Matter Experts

Kenneth Cusi, MD, FACP, FACE

Christopher H. Gibbons, MD, MMSc

John M. Giurini, DPM

Lisa Murdock

Jennifer K. Sun, MD, MPH

Crystal C. Woodward

Deborah Young-Hyman, PhD, FTOS, Fel SBM, CDCES

ADA Staff

Raveendhara R. Bannuru, MD, PhD, FAGE (corresponding author, rbannuru@diabetes.org)

Nuha Ali ElSayed, MD, MMSc

Robert A. Gabbay, MD, PhD

Malaika I. Hill, MA

Laura S. Mitchell