National Screening Program for Islet Autoantibodies in Relatives of Type 1 Diabetes Patients to Identify Early Stages and Prevent DKA

What this Trial Is About

Researchers are conducting a national screening program to detect the presence of islet autoantibodies IA among first-degree relatives of people with type 1 diabetes T1D. The goal is to identify individuals with pre-clinical stages of T1D stages 1 and 2 and help prevent diabetic ketoacidosis DKA at the time of clinical diagnosis. Screening focuses on four specific autoantibodies GADA, IA-2A, IAA, and ZnT8A, using the ADAP assay. Confirmatory testing is done for those with two or more positive autoantibodies using additional methods such as ELISA and RIA. Participants without positive autoantibodies are not followed further, while those with only one positive antibody will be referred for routine medical follow-up based on international guidelines. Those with two or more positive autoantibodies will undergo confirmation testing and, if pre-symptomatic T1D is confirmed, will be referred to an educational program focused on DKA prevention and regular follow-up care. This observational study tracks progression from early stages of T1D through clinical diagnosis and DKA events. Throughout the study, participants will be screened once at entry, and cases of stage 2 and 3 diabetes and DKA will be documented. The primary outcome is the prevalence of multiple autoantibodies in this population over three years. Secondary outcomes include the rate of progression through T1D stages and the occurrence of DKA at diagnosis. The study involves ongoing monitoring and data collection over a three-year period following the initial screening.

A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients