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

Sponsor
IRCCS San Raffaele
Study ID
NCT07670143
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Weeks - 6 Weeks
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
50,000 participants (estimated)

Primary Outcome Measure

Identification of Infants at Risk Greater than 10% for Beta-Cell Autoimmunity and Type 1 Diabetes [ Time Frame: Infants are tested once within the age of 6 weeks ]

Central Contacts

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