Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial

Conclusions/interpretationThe study demonstrated that oral insulin immunotherapy in young genetically at-risk children was safe, but was not associated with an immune response as predefined in the trial primary outcome. Exploratory analyses suggested that antibody responses to oral insulin may occur in children with a susceptibleINS genotype, and that inflammatory episodes may promote the activation of insulin-responsive T cells.Trial registrationClinicaltrials.gov NCT02547519FundingThe main funding source was the German Center for Diabetes Research (DZD e.V.)Graphical abstract

Source: Diabetologia - March 31, 2021 Category: Endocrinology Source Type: research