Clinical Research Directory

Inclusion Criteria: 1. Infants between the ages of 7 days and 6 weeks (+14 days in case of illness or COVID-19 related issues or unexpected delay in result reporting) at the time of randomisation. 2. A 10% or higher genetic risk to develop multiple beta-cell autoantibodies by age 6 years: 1. For infants without a first-degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8 or DR4-DQ8/DR4-DQ8 genotype and a genetic risk score that is in the upper 25th centile (\>14.4) or a DR3/DR4-DQ8 genotype with a GRS between the upper 50th (14.0) and 25th centile and a GG genotype at the rs3763305 SNP. These represent around 1% of all newborns. 2. For infants with a first-degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1\*1501, DQB1\*0503, DRB1\*1303. These represent around 30% of infants with a first-degree family history of T1D. 3. Written informed consent signed by the custodial parent(s).- Exclusion Criteria: 1. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the Investigators. 2. Preterm delivery \< 36 weeks of gestation. 3. Proven immunodeficiency. 4. Any condition that could be associated with poor compliance.5. Diagnosis of diabetes at the time of recruitment