M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials

The goal of this observational study is to identify newborns at increased genetic risk of developing type 1 diabetes-specific beta-cell autoantibodies in order to determine eligibility for participation in primary prevention randomized controlled trials aimed at preventing beta-cell autoimmunity.

NCT Number	NCT07670143
Lead Sponsor	IRCCS San Raffaele Collaborators: Clinica Mangiagalli, Azienda Ospedaliero Universitaria Maggiore della Carita, Azienda Socio Sanitaria Territoriale di Lecco, Ospedale F. Del Ponte, Varese
Conditions	Type 1 Diabetes
Enrollment	50,000 participants
Start Date	2026-07
Primary Completion	2031-06 (estimated)
Study Completion	2031-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-26