Standardizing Clinically Meaningful Outcome Measures Beyond HbA 1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.
Level 5 - mechanism / opinion, no new human data
Multi-organizational expert consensus statement
PubMed 29162582 · doi:10.2337/dc17-1624
What was done
A multi-organization Steering Committee (representing AACE, AADE, ADA, Endocrine Society, JDRF, Helmsley Charitable Trust, PES, and T1D Exchange) conducted the Type 1 Diabetes Outcomes Program to identify and define clinical endpoints beyond HbA1c. The committee gathered input from researchers, industry, and people with type 1 diabetes via Advisory Committees and stakeholder surveys, combining survey results with published evidence and clinical expertise.
What was found
The abstract reports no quantitative numerical data. Stakeholder surveys prioritized five outcome domains: hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). Standardized consensus definitions were established for hypoglycemia, hyperglycemia, time in range, and DKA. The panel concluded that PROs require further type 1 diabetes-specific development and identified remaining knowledge gaps for future research.
Why it matters
This report provides standardized clinical endpoints beyond glycemic control (HbA1c) to guide future research, clinical trials, and regulatory evaluation of type 1 diabetes therapies.
Limits
The abstract provides qualitative consensus recommendations rather than empirical trial data and does not report specific cutoffs, numeric definitions, or sample sizes from the stakeholder surveys. Definitions for patient-reported outcomes were not finalized due to a need for further specific development.
Cited by
- context The American Association of Clinical Endocrinologists advises against relying heavily on hemoglobin A1C testing.