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Clinical Trials in Italy / NCT07670143
Starting soon Observational

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

NCT07670143 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2026-07
Last updated
2026-06-26

Condition(s) studied

Type 1 Diabetes

Study 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

Sex
ALL
Min age
0 Weeks
Max age
6 Weeks
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Identification of Infants at Risk Greater than 10% for Beta-Cell Autoimmunity and Type 1 Diabetes — Infants are tested once within the age of 6 weeks
    Risk score derived from single nucleotide polymorphisms (SNPs) used to identify participants at increased genetic risk.

Trial sites (5)

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

More IRCCS San Raffaele trials in Italy

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Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. Recruiting
Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases Recruiting
Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis Recruiting
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis Recruiting

Other trials for the same condition

Type I Diabetes and Non-surgical Periodontal Treatment Active, not recruiting
A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes Active, not recruiting
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight Active, not recruiting
Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes Recruiting
Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07670143 on ClinicalTrials.gov ↗ ← All trials in Italy