Study of Blood Spot and Serum Tests for Early Detection of Type 1 Diabetes and Celiac Disease in Children Aged 2 to 13 Years

What this Trial Is About

Early diagnosis of type 1 diabetes and celiac disease in children aged 2 to 13 years is important for timely treatment and preventing serious complications like diabetic ketoacidosis. This study evaluates the agreement between two methods of screening for autoantibodies related to these diseases using blood samples from pediatric patients in Tuscany. The study also aims to assess how feasible and acceptable this screening is when done through pediatrician involvement in the community. Participants will undergo two types of diagnostic tests one using blood drawn from a vein during routine clinical care to test serum for autoantibodies by Elisa test, and the other using a finger prick to collect dried blood spots on a special card, which will also be tested for the same autoantibodies with Elisa. Both methods will be compared for accuracy and consistency. Throughout the study, researchers will measure and compare levels of specific autoantibodies linked to type 1 diabetes and celiac disease from both blood samples and dried blood spots. The primary outcome is the comparability of tissue transglutaminase Immunoglobulin A tTg IgA test results. Secondary outcomes include comparisons of other antibodies relevant to these diseases. Participation involves one-time sample collection and testing, with no treatment given. The study is non-randomized and open-label, running until March 2026.

Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease