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

NCT06665815 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2025-05-20

No results posted yet for this study

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

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, Prof. · Schneider Children's Medical Center

Eligibility

Min Age
2 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2027-12-15
Completion
2028-02-15

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665815 on ClinicalTrials.gov