New Classification and Staging Approach for Presymptomatic Type 1
JDRF and the American Diabetes Association, in Collaboration with Multiple Diabetes Organizations Publish New Classification and Staging Approach for Presymptomatic Type 1
Diabetes Organizations Endorse Concept that Autoimmune Disease Begins Long Before Symptoms Occur and Progresses through Distinct Stages, which Provide a Window of Opportunity to Intervene and Prevent Symptomatic Disease
New York, NY, September 24, 2015 - JDRF and the American Diabetes Association (Association), announced today that a new classification approach for staging T1D in its earliest presymptomatic stages would be published in the September 24th online version of Diabetes Care. JDRF convened a group of leading diabetes research and clinical organizations to develop the staging approach, which was published as a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association and endorsed by the American Association of Clinical Endocrinologists, the International Society for Pediatric and Adolescent Diabetes, and The Leona M. and Harry B. Charitable Trust. The pre-clinical staging model embraces the concept that T1D begins prior to symptomatic disease and then progresses to a point of certainty for insulin replacement. The staging approach will aid the development of therapies and the design of clinical trials to prevent symptomatic disease and promote precision medicine. Finally, the staging approach will provide a framework to help inform benefit/risk evaluation in the regulatory, reimbursement, and clinical care settings.
“We know type 1 diabetes begins long before insulin dependence occurs, and the best time to halt the disease’s progress is before the loss of insulin-producing pancreatic beta cells,” said JDRF’s Chief Scientific Officer, Richard Insel, M.D. “Decades of research in at-risk individuals have provided the foundation for developing this new three-stage diagnostic approach, which we believe will help optimize the design of clinical trials to prevent symptomatic disease and more quickly evaluate interventions.”
The design of the new staging system was enabled by recent studies that showed people who test positive for multiple pancreatic islet autoantibodies (Stage 1) and have progressed to developing glucose intolerance or dysglycemia (a disorder of the blood sugar metabolism) from loss of functional pancreatic beta cells (Stage 2) will almost invariably progress to symptomatic T1D (Stage 3). While the rate of progression between stages is variable among individuals, the risk can be defined, which can facilitate clinical trials that aim to preserve functional insulin-producing beta cells.
Currently, T1D is not generally diagnosed until symptoms such as excessive thirst (polydipsia), frequent urination (polyuria), significant weight loss or fatigue become apparent. In fact, a third of T1D cases are diagnosed when a person shows up in an emergency room with an acute case of diabetic ketoacidosis (DKA). When combined with risk detection, the newly developed staging system should prevent this kind of late-stage diagnosis and has been shown to prevent DKA and hospitalization at the time of onset of clinical symptoms.
“Type 1 diabetes is diagnosed relatively late in the disease process. Pre-type 1 diabetes can be identified both in higher risk relatives and the lower risk general population,” said Desmond Schatz, M.D., president-elect, medicine and science at American Diabetes Association. “Using a combination of genetic, immunologic and metabolic markers, distinct categorization of the natural history of the early disease process is now possible. This will facilitate the implementation of specific prevention studies at different stages of the disease process, each with their own distinct endpoints.”
Close relatives of people who have been diagnosed with T1D have an increased risk of developing the disease. Researchers recognize about 50 genetic variants that increase susceptibility to T1D. However, 85 to 90 percent individuals newly diagnosed with T1D have no history of T1D among their relatives.
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 nearly $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 in more than 100 locations 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.
About the American Diabetes Association
The American Diabetes Association is leading the fight to Stop Diabetes® and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information and gives voice to those denied their rights because of diabetes. For the past 75 years, our mission has been to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (800-342-2383) or visit diabetes.org. Information from both these sources is available in English and Spanish.