Randomized, triple-blind, phase 2 trial (NCT02620072) evaluating oral insulin to prevent T1D progression in stage 1, high-risk children aged 2-12 years. The study will assess prevention of dysglycemia or diabetes, as measured by oral glucose tolerance test. Participants are followed for at least 24 months (55). The gene discussed is INS; the disease is type 1 diabetes mellitus.