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NCT07670143
M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials
Conditions: Type 1 Diabetes
Sex: All
Ages: 0 Weeks – 6 Weeks
Healthy volunteers: Yes
Enrollment: 50000
Sponsor: IRCCS San Raffaele
Location: ASST Lecco - Ospedale Manzoni Lecco Lecco
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Screening is performed between the ages of 0 and 6 weeks.
* Consent form signed by parents/guardian.
Exclusion Criteria:
* Infants aged above 6 weeks.
* Refusal to participate in the study
Source: ClinicalTrials.gov (NCT07670143). StuddyBuddy aggregates publicly available trial information.