NCT06665815

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Type 1 Diabetes
• Autoantibodies Screening

Timeline

• Start date: 2024-12-15
• Primary completion: 2027-12-15
• Completion: 2028-02-15
• First posted: 2024-10-30
• Last updated: 2025-05-20

Locations

1 site across 1 country: Israel