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

Starting soon

Conditions studied: Type 1 Diabetes

In brief

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 facts

Study ID

NCT07670143

Run by

IRCCS San Raffaele

People needed

50000

Starts

2026-07-01

Expected to finish

2031-06-01

Last updated by the study team

2026-06-26

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Screening is performed between the ages of 0 and 6 weeks.
• Consent form signed by parents/guardian.

You may not qualify if…

• Infants aged above 6 weeks.
• Refusal to participate in the study

Where it is running

• ASST Lecco - Ospedale Manzoni — Lecco, Lecco, Italy
• Clinica Mangiagalli — Milan, Milano, Italy
• IRCCS Ospedale San Raffaele — Milan, Milano, Italy
• A. O. U. Maggiore della Carità di Novara — Novara, Novara, Italy
• Ospedale Filippo Del Ponte — Varese, Varese, Italy

Full record on ClinicalTrials.gov

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