Richard A Insel, Jessica L Dunne, Mark A Atkinson, Jane L Chiang, Dana Dabelea, Peter A Gottlieb, Carla J Greenbaum, Kevan C Herold, Jeffrey P Krischer, Åke Lernmark0, Robert E Ratner, Marian J Rewers, Desmond A Schatz, Jay S Skyler, Jay M Sosenko, Anette-G Ziegler

Abstract

Insights from prospective, longitudinal studies of individuals at risk for developing type 1 diabetes have demonstrated that the disease is a continuum that progresses sequentially at variable but predictable rates through distinct identifiable stages prior to the onset of symptoms. Stage 1 is defined as the presence of β-cell autoimmunity as evidenced by the presence of two or more islet autoantibodies with normoglycemia and is presymptomatic, stage 2 as the presence of β-cell autoimmunity with dysglycemia and is presymptomatic, and stage 3 as onset of symptomatic disease. Adoption of this staging classification provides a standardized taxonomy for type 1 diabetes and will aid the development of therapies and the design of clinical trials to prevent symptomatic disease, promote precision medicine, and provide a framework for an optimized benefit/risk ratio that will impact regulatory approval, reimbursement, and adoption of interventions in the early stages of type 1 diabetes to prevent symptomatic disease.

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