Endpoints for Clinical Trials in Type 1 Diabetes Drug Development

Type 1 diabetes is characterised by substantial disease heterogeneity which influences rates of progression during presymptomatic stages, age at clinical onset, and residual β-cell function at the time of detectable autoimmunity. This heterogeneity poses challenges for disease staging and calls attention to the need for new surrogate endpoints in trials assessing disease-modifying therapies that better quantify and longitudinally track β-cell function.