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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

5
ASST Lecco - Ospedale Manzoni23900, LeccoLecco, Italy
Clinica Mangiagalli20122, MilanMilano, Italy
IRCCS Ospedale San Raffaele20132, MilanMilano, Italy
A. O. U. Maggiore della Carità di Novara28100, NovaraNovara, Italy

Sponsors and collaborators

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