New Staging System for Presymptomatic Type 1 Diabetes

Released by JDRF, the Endocrine Society, and the American Diabetes Association

Commentary by Richard Insel MD, Desmond Schatz MD, and Kevan Herold MD

A new approach for staging T1D in its earliest presymptomatic stages was released by the JDRF, the Endocrine Society, and the American Diabetes Association. The organizations endorse the concept that autoimmune disease precedes the onset of symptoms and progresses through distinct stages, as reported in the October issue of Diabetes Care.

Type 1 diabetes

The staging system is as follows:

  • Stage 1: individuals who are normoglycemic but test positive for 2 or more type 1 diabetes–associated islet autoantibodies.
  • Stage 2: individuals with 2 or more islet autoantibodies who have developed glucose intolerance or dysglycemia, from loss of functional β-cell mass.
  • Stage 3: individuals who have symptoms of type 1 diabetes, such as polyuria, polydipsia, weight loss, fatigue, and diabetic ketoacidosis.

While the rate of progression between stages is variable among individuals, the risk can be defined, which may facilitate clinical trials that aim to preserve functional insulin-producing beta cells, according to the associations. In addition, while approximately 50 genetic variants that increase susceptibility to T1D have been discovered; 85% to 90% of individuals newly diagnosed with T1D have no history of T1D among their relatives, the associations noted.

“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,” Chief Scientific Officer of JDRF Richard Insel, MD, said in a statement to the press. “Decades of research in at-risk individuals have provided the foundation for developing this new 3-stage diagnostic approach, which we believe will help optimize the design of clinical trials to prevent symptomatic disease and more quickly evaluate interventions.”

“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, MD, 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,” Dr. Schatz said.

Type 1 Diabetes Begins Long Before Clinical Onset
“I think the important message from this consensus document is the recognition that the disease begins very much before the clinical onset and with newer methods, we can identify those individuals who will progress to disease,” commented Kevan Herold, MD, Professor of Immunobiology and of Medicine (Endocrinology); Deputy Director for Translational Science, Yale Center for Clinical Research, Yale University; Director, Yale Diabetes Center, Yale-New Haven Hospital, New Haven, Conn. “This suggests that it may be appropriate to use agents that have shown efficacy in patients with diabetes in those at high risk. Of course, risks need to be weighed against benefits, particularly since the actual timing in any individual is still hard to predict with accuracy. Nonetheless, the data is also a call to action to try to prevent the disease,” Dr. Herold told EndocrineWeb.com.

The staging approach is endorsed by the American Association of Clinical Endocrinologists, the International Society for Pediatric and Adolescent Diabetes, and The Leona M. and Harry B. Helmsley Charitable Trust.

October 18, 2015

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