Protocollo dello studio

A total of 5,363 residents from four regions (Lombardy, Marche, Campania, Sardinia) will be enrolled and stratified into three age groups, as shown in the table, with aregional supervision of recruitment and activities.

Inclusion criteria:

• ages 2, 6 and 10 (+364 days with exceptions at the specific request of the parents)
• signing of the informed consent and privacy policy by parents and delivery of an adapted consent to children capable of reading and understanding its content.

Exclusion criteria:

• diagnosis of type 1 diabetes
• diagnosis of type 1 diabetes and coeliac disease (subjects with diagnosed coeliac disease are not excluded)

Administration of the recruitment questionnaire, including the collection of child's biographical and auxological data as well as family history family history related to the diagnosis of diabetes and coeliac disease.

Assigning a unique code to each subject and entering the data into the D1Ce Screen platform.

Capillary collection of a blood sample in a test tube and 2-3 drops on Guthrie cards.

Determination of specific autoantibodies for type 1 diabetes (anti-GAD; anti-IA2; anti-ZnT8; anti- IA) and coeliac disease (anti-transglutaminase-IgA and IgG, TGA) in serum, and of DQ2/DQ8 from the Guthrie card at the reference laboratories.

Data collection of subjects enrolled in the D1Ce Screen platform including the recruitment questionnaire and test results entered by reference laboratories.

Specialist support from the regional pediatric centers for type 1 diabetes and coeliac disease with which PLSs can interact for in-depth investigations and to whom they can refer positive cases for follow-up.

Data processing of the D1Ce Screen platform at the central level (ISS).