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

Recruiting

• Conditions: Type 1 Diabetes; Autoantibodies Screening

• Registration Number: NCT06665815
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-30
• Study Start: 2024-12-15
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-12-15
• Study Completion: 2028-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Age 2-45 years
• First-degree relatives of Type 1 Diabetes probands
• Signing an informed consent

Exclusion Criteria

• Known diabetes of any kind (type 1, type 2, MODY)
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel	End of screening, 3 years after obtaining the first screening test

Secondary Outcome Measures

Name	Time	Method
The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort	End of screening, 3 years after obtaining the first screening test
Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes	End of screening, 3 years after obtaining the first screening test
>500 individuals with pre-clinical Type 1 Diabetes identified in the cohort	End of screening, 3 years after obtaining the first screening test

Trial Locations

Locations (1)

Schneider Children Medical Center of Israel; 🇮🇱 Petach-Tikva, Israel