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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorIRCCS San Raffaele

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Screening is performed between the ages of 0 and 6 weeks.

Consent form signed by parents/guardian.

Disqualifiers

Infants aged above 6 weeks.

Refusal to participate in the study

Trial population

This study includes infants aged between 0 and 6 weeks, both male and female.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
Infants are tested once within the age of 6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Clinica Mangiagalli

Collaborator

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Collaborator

Azienda Socio Sanitaria Territoriale di Lecco

Collaborator

Ospedale F. Del Ponte, Varese

Collaborator

This trial is not recruiting at the moment. You can still explore other options: