T1D Outcomes Program

A multi-stakeholder effort to more completely define type 1 diabetes (T1D) outcomes

The T1D Outcomes Program is an effort launched by the T1D community to develop better ways to define clinically meaningful T1D outcomes beyond hemoglobin A1c (HbA1c).

Why do we need better T1D outcomes?

The metric used most frequently to evaluate the effectiveness of diabetes treatment is HbA1c, which tells average blood glucose over a three-month period. While HbA1c measurement remains very important in the evaluation of diabetes therapies, it does have limitations (e.g., its capability to capture real-time variations in blood-glucose levels).

Recent advancements in T1D research suggest that other outcomes, in addition to HbA1c, can be used to measure the effectiveness of a T1D therapy. However, these concepts are not yet widely accepted or consistently defined, slowing the development of new therapies that target outcomes in addition to HbA1C.

Who is involved?

A Steering Committee comprising representatives from a variety of organizations collaborated on this initiative.

  • American Association of Clinical Endocrinologists
  • American Association of Diabetes Educators
  • American Diabetes Association
  • Endocrine Society
  • JDRF International
  • The Leona M. and Harry B. Helmsley Charitable Trust
  • Pediatric Endocrine Society
  • T1D Exchange

The Steering Committee’s work has been informed by Advisory Committees composed of people with diabetes, diabetes researchers and industry.

What is the end result?

Using existing evidence and the collective expertise of the Advisory Committees, the Steering Committee has come to consensus on definitions for:

  • Hypoglycemia
  • Hyperglycemia
  • Time in range
  • Diabetic ketoacidosis

The T1D Outcomes Program Steering Committee believes these definitions can have an important impact on the way new diabetes treatments and therapies are evaluated.

The use of patient reported outcomes is important and was also considered by the Steering Committee. However, a recommendation on specific instruments is not included in the consensus statement at this time.

The draft consensus statement was made available for 30 days for public comment. Currently, the Steering Committee is considering the comments received as they finalize the consensus document which should be complete in summer 2017.