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Finding newborns at higher risk of type 1 diabetes for prevention studies

Identifies newborns with higher genetic risk of type 1 diabetes for prevention trials.

Plain-language title generated from the registry record
Registry title: M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials

Key facts

Where
Lecco, Milan, Novara, and Varese, ItalySee the 5 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The study is looking for newborns up to 6 weeks old to find out which babies have a higher genetic risk of type 1 diabetes. This may allow them to join prevention trials.

Age
0 to 6 weeks
Sex
Boys and girls can both join.
Biomarker or test result
Increased genetic risk of developing type 1 diabetes-specific beta-cell autoantibodies is what the study looks for.

Main reasons for not taking part

  • Babies older than 6 weeks
  • Parents or guardian refuse to take part

Read by machine on 13 November 2026.

Where in Italy

  • ASST Lecco - Ospedale ManzoniLecco, ItalyContact: Roberto Bellù, MDNo longer taking part
  • Clinica MangiagalliMilan, ItalyContact: Monica Fumagalli, Associate ProfessorNo longer taking part
  • IRCCS Ospedale San RaffaeleMilan, ItalyContact: Emanuele Bosi, ProfessorNo longer taking part
  • A.O.U. Maggiore della Carità di NovaraNovara, ItalyContact: Ivana Rabbone, ProfessorNo longer taking part
  • Ospedale Filippo del PonteVarese, ItalyContact: Massimo Agosti, ProfessorNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
IRCCS San Raffaele
Trial code
NCT07670143
Record updated
26 June 2026
Original description
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.Read full original descriptionShow less

Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials.

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.

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

Exclusion: Infants aged above 6 weeks; Refusal to participate in the study.

ClinicalTrials.gov NCT07670143