Introduction and Methodology: Standards of Care in Diabetes – 2024

The “Standards of Care in Diabetes,” a document by the American Diabetes Association (ADA), plays a pivotal role in guiding the management of diabetes. This multifaceted, chronic condition demands ongoing medical attention and incorporates diverse strategies beyond just managing blood sugar levels. The Standards of Care in Diabetes are designed to furnish clinicians, researchers, policymakers, and others with the essential elements of diabetes care, overarching treatment objectives, and tools for assessing the quality of care.

Continual education and support for individuals in self-managing diabetes are crucial for empowerment, preventing immediate complications, and minimizing the risk of long-term issues. Substantial evidence underscores various interventions that can enhance outcomes for individuals with diabetes, as highlighted in the ADA’s Standards of Care.

Updated annually by the ADA Professional Practice Committee (PPC), the Standards of Care aims to encompass discussions on emerging clinical considerations and incorporate evolving clinical guidance as evidence progresses. This dynamic document is considered a “living” resource, with prompt online publication of significant updates when the PPC deems it necessary due to new evidence or regulatory changes, such as drug or technology approvals or label modifications.

Scope of the Guideline

The recommendations outlined in the Standards of Care encompass screening, diagnostic, and therapeutic measures that are either known or believed to impact the health outcomes of individuals with diabetes positively. They address not only the prevention, screening, diagnosis, and management of complications and comorbidities associated with diabetes but also guide care across the entire lifespan. This includes youth (children from birth to 11 years and adolescents aged 12–17 years), adults (18–64 years old), and older adults (65 years and above). The recommendations are inclusive of the management of various types of diabetes, including type 1 and type 2 diabetes, gestational diabetes mellitus, and other forms of diabetes and hyperglycemic conditions.

The Standards of Care does not present exhaustive treatment plans for diabetes-related complications like diabetic retinopathy or diabetic foot ulcers. Instead, it provides

• guidance on the timing and methods for screening complications,
• managing them in primary care and diabetes care contexts, and
• making referrals to specialists as necessary.

Similarly, for psychosocial and behavioral health factors linked to diabetes that may impact diabetes care, the Standards of Care offer guidance on screening, management in primary and diabetes care settings, and referral protocols. However, it does not furnish comprehensive management plans for conditions demanding specialized care, such as mental illness.

Target Audience

The intended audience for the Standards of Care encompasses a broad range of healthcare professionals, including primary care physicians, endocrinologists, nurse practitioners, physician associates/assistants, pharmacists, dietitians, and diabetes care and education specialists, along with all members of the diabetes care team. Moreover, the Standards of Care guides specialists caring for individuals with diabetes and its complications, such as cardiologists, nephrologists, emergency physicians, internists, pediatricians, psychologists, neurologists, ophthalmologists, and podiatrists. Additionally, these recommendations serve as a valuable resource for payers, policymakers, researchers, research funding organizations, and advocacy groups, aiding them in aligning their policies and resources to deliver optimal care for individuals with diabetes.

The ADA is committed to enhancing and revising the Standards of Care to maintain its status as the foremost and up-to-date reference for current diabetes care guidelines, ensuring its continued trustworthiness for clinicians, health plans, and policymakers. It’s essential to note that the recommendations in the Standards of Care are not meant to override clinical judgment. Instead, they should be applied within excellent clinical care, allowing for adjustments based on individual preferences, comorbidities, and other patient-specific factors.

1. The ADA is dedicated to improving and updating the Standards of Care.
2. The goal is to maintain its position as the leading and current source of diabetes care guidelines.
3. Trustworthiness ensures continued reliability for clinicians, health plans, and policymakers.

Note: The Standards of Care recommendations do not replace clinical judgment. Instead, they should be applied within excellent clinical care, allowing for adjustments based on individual preferences, comorbidities, and other patient-specific factors.

Methodology and Procedure of Standards of Care in Diabetes

The Standards of Care incorporate deliberations on evidence and clinical practice recommendations to enhance care for individuals with diabetes. Its purpose is to aid healthcare professionals and individuals in collaboratively making decisions about diabetes care. These recommendations are shaped by a systematic review of evidence and an evaluation of the benefits and risks associated with alternative care options.

Professional Practice Committee (P.P.C.):

1. Responsibility for Standards of Care:
   • The A.D.A.’s P.P.C. is responsible for developing and maintaining the Standards of Care.
2. Interprofessional Expert Committee:
   • Comprises physicians, nurse practitioners, pharmacists, diabetes care and education specialists, registered dietitian nutritionists, and behavioral health scientists.
   • Diverse expertise in adult and pediatric endocrinology, epidemiology, public health, cardiovascular risk management, and more.
3. Appointment Criteria:
   • Membership is based on excellence in clinical practice and research.
   • Consideration for appropriate representation based on demographic, geographic, work setting, and identity characteristics.
4. P.P.C. Chairperson:
   • Appointed by the A.D.A. (currently N.A.E.) to oversee the committee.
5. External Expert Involvement:
   • For the 2024 Standards of Care, experts from A.C.C. contributed to Section 10, “Cardiovascular Disease and Risk Management.”
   • In 2024, experts from ASBMR and T.O.S. contributed to specific subsections, namely “Bone Health” in Section 4 and “Obesity and Weight Management for the Prevention and Treatment of Type 2 Diabetes” in Section 8, respectively.
6. Section Review and Updates:
   • Each section is reviewed annually by a designated P.P.C. member acting as the section lead.
   • Subcommittees, including an information specialist (librarian) for literature searches, perform systematic reviews and summarize scientific evidence.
   • A guideline methodologist (R.R.B. for 2024 Standards) oversees methodological aspects and is a statistical analyst in development.

Disclosure and Duality of Interest Management:

1. Compliance Requirement:
   • All members (PPC, subject matter experts, and ADA staff) must adhere to ADA’s policy on duality of interest.
2. Scope of Disclosure:
   • Mandates disclosure of financial, intellectual, or other interests, regardless of relevance to the guideline topic.
   • Full disclosure is required for transparency, encompassing all relationships.
3. Appointment Process:
   • Full disclosure statements are solicited and reviewed during the appointment process.
4. Ongoing Updates:
   • Disclosures are updated throughout guideline development, specifically before each meeting.
   • Authors of Standards of Care sections submit disclosure statements upon revising and presenting their work.
5. Disclosure Time Frame:
   • Members must disclose for one year before committee appointment initiation until publication of that year’s Standards of Care.
6. Evaluation Process:
   • A designated review group evaluates potential dualities of interest and, if needed, the ADA’s Legal Affairs Division.
   • Assessment considers both the monetary amount and the relevance of the relationship.
7. Adherence to External Code:
   • ADA follows section 7 of the Council of Medical Specialty Societies “Code for Interactions with Companies.”
8. PPC Composition:
   • Ensures a majority of the PPC and the PPC chair have no potential conflicts relevant to the subject area.
   • The PPC chair is required to remain unconflicted for one-year post-publication.
9. Restrictions on Participation:
   • Members disclosing potential dualities of interest related to specific recommendations are barred from participating in discussions on those recommendations.
10. Pharmaceutical or Device Company Affiliation:
    • No pharmaceutical or medical device company employed expert panel members while developing the 2024 Standards of Care.
11. Transparency in Disclosures:
    • Information on PPC members, their employers, and disclosed potential dualities of interest is accessible in the “Disclosures: Standards of Care in Diabetes—2024.”
12. Funding Source:
    • ADA funds the Standards of Care development from general revenue and does not use industry support.

Review of Evidence

The Standards of Care Subcommittee undertakes the initial compilation of pertinent clinical queries in each section, and subsequently, it undergoes thorough examination and discourse by the expert panel. With the guidance of a systematic review specialist, each subcommittee formulates and executes frequent literature searches. For the 2024 Standards of Care, comprehensive searches were conducted on PubMed, Medline, and EMBASE, covering the period from June 1, 2022, to July 21, 2023, with a restriction to studies published in English.

Subcommittee members also manually explore journals, scrutinize reference lists in conference proceedings, and inspect the websites of regulatory agencies. Every potentially relevant citation then undergoes a comprehensive full-text review. Collaborating with the methodologist, the subcommittees craft evidence summaries and assign grades for each section of the Standards of Care. Subsequently, all members of the PPC engage in discussions and reviews of the evidence summaries, making necessary amendments. The PPC then deliberates the final evidence summaries, drafting recommendations that will be incorporated into the Standards of Care.

Evidence Grading and Recommendation Formulation

The ADA employs a grading system (refer to Table 1), developed and modeled after existing methods, to elucidate and systematize the evidence underpinning the recommendations outlined in the Standards of Care. It is crucial to note that all suggestions in the Standards of Care are deemed critical for comprehensive care, irrespective of their rating. The ADA utilizes ratings A, B, or C for its recommendations, depending on the quality of evidence supporting each recommendation.

Additionally, a distinct category labeled “Expert opinion E” exists for recommendations lacking evidence from clinical trials, where conducting such trials may be impractical or when conflicting evidence exists. Recommendations assigned an E level are shaped by insights from key opinion leaders in the diabetes field, namely members of the PPC, covering essential aspects of clinical care.

It is essential to clarify that the rating assigned to Standards of Care recommendations pertains to the strength of the evidence, not the strength of the recommendation itself. Recommendations backed by A-level evidence stem from robust, well-designed, randomized controlled trials or thorough meta-analyses of such trials. These recommendations will likely improve outcomes when applied to the appropriate population. On the other hand, recommendations supported by lower levels of evidence may carry equal importance but lack the same degree of robust support.

Table 1: ADA evidence-grading system for “Standards of Care in Diabetes”

Certainly, the published evidence represents just one facet of clinical decision-making. Clinicians are dedicated to the well-being of individuals, not populations; thus, guidelines should always be approached with a focus on each person’s unique circumstances. Various factors, including the presence of comorbid and coexisting conditions, age, educational background, disabilities, and, most importantly, the values and preferences of the individual with diabetes, must be taken into account. These factors can influence and potentially lead to distinct treatment goals and strategies.

Moreover, traditional evidence hierarchies, like the one embraced by the ADA, may overlook subtleties that hold significance in diabetes care. For instance, while robust evidence from clinical trials emphasizes the importance of achieving control over multiple risk factors, the optimal approach to achieving this outcome remains less evident. The intricate nature of such interventions makes it challenging to assess each component comprehensively.

Evidence to Recommendations

The gathered evidence underwent thorough examination and discourse among all PPC members, conducted through virtual meetings and a 2-day in-person session held in Arlington, Virginia, in July 2023. In light of the newly obtained evidence, revisions were made to the Standards of Care recommendations. The PPC engaged in a voting process, with a prerequisite of 80% consensus for approving any recommendation.

Revision Process

The ADA’s Standards of Care revision process involves a year-long public comment period, fostering transparency and allowing stakeholders to pinpoint and address care gaps. Public input, obtained through the professional community and general public, played a crucial role in revising the 2023 Standards of Care. The revision also incorporates feedback from external peer reviewers, ADA clinical leadership, and scientific and medical staff. The approval comes from the ADA Board of Directors, which includes healthcare professionals, scientists, and lay individuals. External endorsements are sought from organizations such as the ACC, ASBMR, and TOS for specific sections. The ADA strictly follows the CMSS Principles for Developing Specialty Society Clinical Guidelines.

ADA Standards, Statements, Reports, and Reviews

For over 30 years, the ADA has been key in creating and sharing clinical practice recommendations and documents for diabetes care. The ADA Standards of Care is a crucial resource for healthcare professionals managing diabetes, complemented by support from ADA Statements, Consensus Reports, and Scientific Reviews.

ADA Statement

An ADA statement represents the official viewpoint or stance of the ADA, addressing advocacy, policy, economic, or medical issues related to diabetes. While lacking clinical practice recommendations, ADA statements undergo a thorough review process, including external peer review and assessment by the ADA national committee, clinical leadership, and the Board of Directors as needed.

Consensus Report

A consensus report authored by an expert panel offers a comprehensive analysis and opinion on a specific diabetes-related topic. It is generated when there’s a need for guidance on issues with contradictory or incomplete evidence. Consensus reports, not reflecting ADA positions, undergo a formal review process, including external peer review and evaluation by the ADA national committee, clinical leadership, and staff, often following an ADA Clinical Conference or Research Symposium.

Scientific Review

A scientific review is a balanced analysis of literature on a scientific or medical topic related to diabetes, providing a rationale for clinical practice recommendations in the Standards of Care. Produced by invited experts under ADA auspices, scientific reviews, which may include task force and expert committee reports, are not ADA positions and don’t contain clinical practice recommendations.

Reference

American Diabetes Association Professional Practice Committee; Introduction and Methodology: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S1–S4. https://doi.org/10.2337/dc24-SINT

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