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

A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 \& 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA. A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA. Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.

NCT Number	NCT06665815
Lead Sponsor	Rabin Medical Center
Conditions	Type 1 Diabetes, Autoantibodies Screening
Enrollment	20,000 participants
Start Date	2024-12-15
Primary Completion	2027-12-15 (estimated)
Study Completion	2028-02-15 (estimated)
Updated on ClinicalTrials.gov	2025-05-20