Introduction: Standards of Medical Care in Diabetes—2022

The ADA has been actively involved in the development and dissemination of diabetes care clinical practice recommendations 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.

To update the Standards of Care, the ADA’s Professional Practice Committee (PPC) performs an extensive clinical diabetes 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 evidence evolves, clinical guidance may be included in the recommendations. However, the Standards of Care is a “living” document, where important updates are published online should the PPC determine that new evidence or regulatory changes (e.g., drug approvals, label changes) merit immediate inclusion. More information on the “living Standards” can be found on the ADA’s professional website DiabetesPro at professional.diabetes.org/content-page/living-standards. The Standards of Care supersedes all previous ADA position statements—and the recommendations 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 Directors and is reviewed by ADA’s clinical staff leadership.

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

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 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.

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.

Since the ADA first began publishing clinical practice guidelines, there has been considerable evolution in the evaluation of scientific evidence and in the development of evidence-based guidelines. In 2002, the ADA developed a classification system to grade the quality of scientific evidence supporting ADA recommendations. 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 Standards of Care for the first time having the majority of bulleted recommendations supported by A level or B level 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 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 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. 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 patients, not populations; 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. 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.