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A High-Throughput Multiplexed Screening for Type 1 Diabetes, Celiac Diseases, and COVID-19
Published on: July 5, 2022
Study protocol of D1Ce Screen: A pilot project of the Italian national screening program for type 1 diabetes and
Olimpia Vincentini1, Flavia Pricci2, Marco Silano2
1Department of Food Safety, Nutrition and Veterinary Public Health, Istituto Superiore di Sanità, Rome, Italy.
Insights
The D1Ce Screen pilot study assesses the feasibility of a new law for early detection of type 1 diabetes (T1D) and celiac disease (CD) in children using autoantibody screening. This program aims to reduce the impact of these chronic conditions through early identification.
Area of Science:
- Pediatric Endocrinology
- Autoimmune Diseases
- Public Health Screening
Background:
- Italian Law 130/2023 mandates screening for pre-symptomatic type 1 diabetes (T1D) and silent celiac disease (CD) in children.
- Early detection of T1D and CD is crucial to mitigate severe chronic health impacts in childhood.
- The D1Ce Screen pilot study is a response to this legislative requirement.
Purpose of the Study:
- To evaluate the organizational feasibility, acceptability, and sustainability of the T1D and CD screening program within the Italian National Health Service.
- To conduct a scaled-down assessment prior to a potential nationwide rollout.
Main Methods:
- An observational, multicenter study involving 5,363 children aged 2-10.9 years across four Italian regions.
- Screening via autoantibody measurement on capillary blood (finger prick) for T1D and CD markers, with HLA typing for CD risk.
- Data collection by primary care pediatricians, including feasibility metrics (participation rates, blood collection success) and cost evaluation.
Main Results:
- The study aims to assess feasibility, acceptability, and sustainability metrics for the proposed screening program.
- Secondary objectives include determining the prevalence of T1D and CD autoantibodies in different age groups.
- The study will provide data on the frequency of pre-symptomatic T1D (Stage 1 & 2) and undiagnosed CD.
Conclusions:
- The D1Ce Screen pilot study will inform the implementation of a nationwide screening program for T1D and CD in Italy.
- Findings will guide the integration of autoantibody screening into routine pediatric care.
- Successful implementation could significantly reduce the long-term burden of these autoimmune diseases in children.
Background:
The D1Ce Screen pilot study stems from the Italian Republic Law 130/2023 introducing the screening based on autoantibody measurement on capillary blood for the identification of people in pre-symptomatic, early phase of type 1 diabetes (T1D) and/or having silent celiac disease (CD) in the general paediatric population to reduce the impact of the two more frequent and severe chronic diseases of childhood.
Aim:
Primary aim is to assess, on a smaller scale, the organizational feasibility, acceptability and sustainability by the National Health Service of the screening program to be conducted nationwide in Italy according to the law.
Methods And Analysis:
This is an observational multicenter study, planning to screen 5,363 children from four Italian regions (Lombardy, Marche, Campania, Sardinia), proportionally distributed according to population of the single Regions, representative of the North, Centre, South and Islands of Italy. Participants are screened by autoantibodies within three classes of age 2-2.9, 6-6.9, and 10-10.9 years, corresponding to reported peaks of seroconversion, in order to maximize the identification of future cases of disease. HLA typing for HLA DQ2 and DQ8 is also performed for CD risk in dry blood spots (DBS). Screening procedures are conducted by primary care paediatricians (PCPs), responsible for: direct contact with families; information about the study; administration of written informed consent, privacy statement and questionnaires; execution of blood drawing by finger prick; capillary blood collection for autoantibody and HLA testing and shipment to the central laboratory. Feasibility, acceptability and sustainability will be estimated by number of participating paediatricians; screened children in the four Regions and within the classes of age; feedback questionnaires; number of fingerpicks to obtain sufficient capillary blood for assays; any adverse events; costs evaluation in relation to assigned budget. Secondary objectives include frequency of T1D and CD specific autoantibodies to assess the prevalence of pre-symptomatic (Stage 1 and Stage 2) TD1 and undiagnosed CD in the three classes of age of general paediatric population.
Study Registration:
D1Ce Screen is not registered to any International Study Registry, as it is a pilot observational study requested by the Italian law 130/2023.
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