T1D Program Defines Clinically Meaningful Outcomes
In partnership with other members of the T1D Outcomes Program Steering Committee, Helmsley has jointly come to a consensus in defining and standardizing meaningful type 1 diabetes (T1D) outcomes other than hemoglobin HbA1c (A1c), which is an average of blood glucose levels over a three-month period. Although A1c remains an important measure, its limitation as an average means it does not capture the entire picture of glycemic control, particularly around day-to-day variability in blood-glucose levels. The statement, published in Diabetes Care, a journal of the American Diabetes Association, defines additional clinically meaningful T1D outcomes beyond A1c such as hypoglycemia, time in range, hyperglycemia, and diabetic ketoacidosis (DKA).
The intended impact of these outcome definitions and standardizations is to encourage regulatory agencies and payors to consider the bigger picture of glycemic control when evaluating new diabetes treatments and technology. The consensus statement was developed over the course of two years and incorporates diverse perspectives from persons living with T1D and their caregivers, clinical experts, industry, Advisory Committees representing researchers, and clinical evidence.
Led by grantee JDRF International, the fellow T1D stakeholders represented in the Steering Committee also include: the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, the Pediatric Endocrine Society, and the T1D Exchange.