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Leading Diabetes Organizations Issue Consensus Statement Defining Health Outcomes beyond HbA1c | ||
By: PR Newswire Association LLC. - 21 Nov 2017 | Back to overview list |
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NEW YORK, Nov. 21, 2017 /PRNewswire-USNewswire/ -- 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. ABOUT T1D ABOUT JDRF
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