M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials
M1N0
Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials.
2 other identifiers
observational
50,000
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
June 26, 2026
June 1, 2026
4.9 years
June 18, 2026
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of Infants at Risk Greater than 10% for Beta-Cell Autoimmunity and Type 1 Diabetes
Risk score derived from single nucleotide polymorphisms (SNPs) used to identify participants at increased genetic risk.
Infants are tested once within the age of 6 weeks
Eligibility Criteria
This study includes infants aged between 0 and 6 weeks, both male and female.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IRCCS San Raffaelelead
- Clinica Mangiagallicollaborator
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novaracollaborator
- Azienda Socio Sanitaria Territoriale di Leccocollaborator
- Ospedale F. Del Ponte, Varesecollaborator
Study Sites (5)
ASST Lecco - Ospedale Manzoni
Lecco, Lecco, 23900, Italy
Clinica Mangiagalli
Milan, Milano, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, Milano, 20132, Italy
A. O. U. Maggiore della Carità di Novara
Novara, Novara, 28100, Italy
Ospedale Filippo Del Ponte
Varese, Varese, 21100, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Gabriele D. Mogliarisi, Clinical Research Coordinator
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emanuele Bosi, Professor
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 26, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
June 26, 2026
Record last verified: 2026-06