—The Type 1 Diabetes Outcomes Program, organized by JDRF, has identified and defined clinically meaningful T1D outcomes other than the standard measure of HbA1c—
NEW YORK, November 21, 2017 – A committee representing leading U.S. diabetes clinical and research organizations has issued a consensus statement that identifies and defines clinically meaningful type 1 diabetes (T1D) outcomes beyond hemoglobin HbA1c (A1c). The Steering Committee for the Type 1 Diabetes Outcomes Program, organized by JDRF, released the consensus statement, “Standardizing Clinically Meaningful Outcome Measures Beyond HbA1C for Type 1 Diabetes”, to be published online today in the journal Diabetes Care. The statement formally acknowledges other priority health outcomes, such as hypoglycemia and time in a normal blood glucose range, which should be considered in the development and evaluation of new therapies and technologies for T1D.
The culmination of a two-year effort, the consensus statement was developed based on a review of clinical evidence, consensus from clinical experts, and input from Advisory Committees representing researchers, industry and people with type 1 diabetes. The Steering Committee includes representatives 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 T1D Exchange.
“This consensus statement is the first time the clinical world has collectively recognized priority outcomes for people with type 1 diabetes beyond A1c,” said Aaron Kowalski, Ph.D., JDRF Chief Mission Officer. “The statement more completely acknowledges the day-to-day experience of people living with T1D and accounts for the many risks of this disease. It also paves the way to ensuring that outcomes like reduced episodes of hypoglycemia and greater time in range are included on the labels of drugs, devices and other T1D therapies.”
A1c is the accepted primary outcome measure for glycemic control and evaluating the efficacy of diabetes therapies, but it has limitations. It measures a person’s average (mean) blood glucose over a three-month period but does not capture the number or frequency of extreme highs and lows (hyperglycemia and hypoglycemia) in blood sugar. Hypoglycemia alone accounts for close to 300,000 emergency department visits each year.
Recent advances in technology have made it possible to assess the efficacy of T1D therapies using a broader set of outcomes; however, clinical definitions for outcomes such as hypoglycemia have not been standardized within the T1D community, leading to a lack of consistency across institutions, impediments in the development process for new clinical therapies, and denials of reimbursement for therapies that can dramatically improve the health of people with T1D. To address this issue, the Steering Committee identified and developed consensus definitions for several priority T1D outcomes beyond A1c, including hypoglycemia, time in a normal blood glucose range, hyperglycemia and diabetic ketoacidosis (DKA).
The Steering Committee recommends using the defined clinically meaningful outcomes beyond HbA1c in research, development and evaluation of T1D therapies, and as the basis of value-based reimbursement approaches.
Type 1 diabetes (T1D) is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and — at present — nothing you can do to get rid of it.
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.
JDRF Manager, Public Relations & Communications