D1Ce Screen pilot project for type 1 diabetes and coeliac disease: the Study protocol

What is it about?

Following the Italian Law 130/2023, the D1Ce Screen pilot study aims to implement and evaluate a nationwide screening program for early detection of pre-symptomatic Type 1 Diabetes (T1D) and silent Celiac Disease (CD) in children. The screening is based on autoantibody detection and HLA typing using capillary blood. This is an observational multicenter study. 5,363 children from 2, 6 and 10 years were enrolled from four Italian regions (Lombardy, Marche, Campania, Sardinia), representing the North, Centre, South, and Islands. Primary care paediatricians (PCPs) managed recruitment, informed consent, sample collection, and family engagement. The primary aim is to assess on a smaller scale the organizational feasibility, acceptability and sustainability within the National Health Service of the pediatric screening program contained in the law. Secondary aims are to estimate the prevalence T1D and CD specific autoantibodies, the frequency of HLA Class II DQ2 and DQ8 haplotypes conferring risk for CD and the association of CD and T1D antibodies with HLA types

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Photo by Ashton Bingham on Unsplash

Photo by Ashton Bingham on Unsplash

Why is it important?

The study promoted by the Italian Ministry of Health and implemented through its operating arm, Istituto Superiore di Sanità (ISS), investigates feasibility, acceptability and sustainability within the National Health System of the screening program contained in the law. The rationale is to identify the challenges of translating the law content into a Public Health Program.