Type 1 DiabetesM1N0NCT07670143
M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials
An observational study of Type 1 Diabetes, run by IRCCS San Raffaele at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 50,000 participants
- Where
- 5 sitesItaly
- Study dates
- Jul 2026to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study includes infants aged between 0 and 6 weeks, both male and female.
Who may be able to join
- Screening is performed between the ages of 0 and 6 weeks.
- Consent form signed by parents/guardian.
Who cannot join
- Infants aged above 6 weeks.
- Refusal to participate in the study
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriele D. Mogliarisi, Clinical Research Coordinator contact
5 sites in 1 country
Italy5 sites
ASST Lecco - Ospedale Manzoni
Lecco, Lecco, 23900
Roberto Bellù, MD, 0039 0341 489215, r.bellu@asst-lecco.it
Roberto Bellù, MD
Clinica Mangiagalli
Milan, Milano, 20122
Monica Fumagalli, Associate Professor, 0039 02 5503 2907, monica.fumagalli@policlinico.mi.it
Monica Fumagalli, Associate Professor
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Emanuele Bosi, Professor, 0039 02 2643 2821, bosi.emanuele@hsr.it
Emanuele Bosi, Professor
A. O. U. Maggiore della Carità di Novara
Novara, Novara, 28100
Ivana Rabbone, Professor, 0039 0321 3733788, ivana.rabbone@uniupo.it
Ivana Rabbone, Professor
Ospedale Filippo Del Ponte
Varese, Varese, 21100
Massimo Agosti, Professor, 0039 0332 299421, massimo.agosti@uninsubria.it
Massimo Agosti, Professor
About this study
Official title: 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.
Read the detailed description
Type 1 diabetes is one of the most common chronic diseases of childhood, with incidence rates increasing worldwide. The disease is caused by immunemediated destruction of the insulin-producing beta cells of the pancreas, ultimately resulting in lifelong insulin deficiency. Before the clinical onset of type 1 diabetes, individuals often develop circulating autoantibodies against pancreatic beta-cell antigens, which are markers of loss of immune tolerance and early autoimmune activity. The development of type 1 diabetes is influenced by both genetic susceptibility and environmental factors. Although the risk of type 1 diabetes in the general European population is relatively low (approximately 0.4%), certain genetic profiles are associated with substantially increased risk. In particular, variants within the Human Leukocyte Antigen (HLA) region on chromosome 6, especially HLA DR and DQ haplotypes, represent the strongest known genetic determinants of disease susceptibility. Additional non-HLA genetic loci further contribute to risk stratification. Previous studies have demonstrated that newborns and infants at increased risk for developing beta-cell autoimmunity and type 1 diabetes can be identified through genetic screening. Infants with a first-degree relative affected by type 1 diabetes already have an estimated disease risk of approximately 5%. Among these individuals, the presence of specific HLA genotypes, including HLA DR4-DQ8 and HLA DR3/DR4-DQ8 combinations, is associated with further increased susceptibility. Incorporation of additional type 1 diabetes susceptibility markers allows identification of infants with a greater than 10% risk of developing multiple beta-cell autoantibodies during early childhood. This study aims to identify neonates and infants with increased genetic risk for type 1 diabetes through analysis of HLA and additional susceptibility markers. Genetic risk assessment will be used to identify participants who may be eligible for primary prevention clinical trials designed to prevent or delay the development of beta-cell autoimmunity and progression to type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Genetic Testing, Infants, M1N0
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Infants are tested once within the age of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Mangiagalli, Azienda Ospedaliero Universitaria Maggiore della Carita, Azienda Socio Sanitaria Territoriale di Lecco, Ospedale F. Del Ponte, Varese
- Responsible party
- Principal investigator, Bosi Emanuele, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670143
- Sponsor's protocol ID
- M1N0
- Other IDs
- GPPAD-02
- Acronym
- M1N0
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials.
- ClinicalTrials.gov ID
- NCT07670143
- Acronym / sponsor ID
- M1N0 / M1N0
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Genetic Testing, Infants, M1N0
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Clinica Mangiagalli, Azienda Ospedaliero Universitaria Maggiore della Carita, Azienda Socio Sanitaria Territoriale di Lecco, Ospedale F. Del Ponte, Varese
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 1 diabetes is one of the most common chronic diseases of childhood, with incidence rates increasing worldwide. The disease is caused by immunemediated destruction of the insulin-producing beta cells of the pancreas, ultimately resulting in lifelong insulin deficiency. Before the clinical onset of type 1 diabetes, individuals often develop circulating autoantibodies against pancreatic beta-cell antigens, which are markers of loss of immune tolerance and early autoimmune activity. The development of type 1 diabetes is influenced by both genetic susceptibility and environmental factors. Although the risk of type 1 diabetes in the general European population is relatively low (approximately 0.4%), certain genetic profiles are associated with substantially increased risk. In particular, variants within the Human Leukocyte Antigen (HLA) region on chromosome 6, especially HLA DR and DQ haplotypes, represent the strongest known genetic determinants of disease susceptibility. Additional non-HLA genetic loci further contribute to risk stratification. Previous studies have demonstrated that newborns and infants at increased risk for developing beta-cell autoimmunity and type 1 diabetes can be identified through genetic screening. Infants with a first-degree relative affected by type 1 diabetes already have an estimated disease risk of approximately 5%. Among these individuals, the presence of specific HLA genotypes, including HLA DR4-DQ8 and HLA DR3/DR4-DQ8 combinations, is associated with further increased susceptibility. Incorporation of additional type 1 diabetes susceptibility markers allows identification of infants with a greater than 10% risk of developing multiple beta-cell autoantibodies during early childhood. This study aims to identify neonates and infants with increased genetic risk for type 1 diabetes through analysis of HLA and additional susceptibility markers. Genetic risk assessment will be used to identify participants who may be eligible for primary prevention clinical trials designed to prevent or delay the development of beta-cell autoimmunity and progression to type 1 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study includes infants aged between 0 and 6 weeks, both male and female.
Key inclusion criteria (2 listed)
- Screening is performed between the ages of 0 and 6 weeks.
- Consent form signed by parents/guardian.
Key exclusion criteria (2 listed)
- Infants aged above 6 weeks.
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of Infants at Risk Greater than 10% for Beta-Cell Autoimmunity and Type 1 Diabetes
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriele D. Mogliarisi, Clinical Research Coordinator contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by IRCCS San Raffaele at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Bosi, Professor (0039 02 2643 2821, bosi.emanuele@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Infants at Risk Greater than 10% for Beta-Cell Autoimmunity and Type 1 Diabetes (time frame: Infants are tested once within the age of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.