A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients (ADIR Families)

May 15, 2025 updated by: Rabin Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petach-Tikva, Israel
        • Recruiting
        • Schneider Children Medical Center of Israel
        • Principal Investigator:
          • Moshe Phillip, Prof
        • Sub-Investigator:
          • Tal Oron, Dr.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

First degree relatives of patients with Type 1 diabetes from all over Israel, aged 2-45 years old

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Negative result at the autoantibodies screening test
  1. Participants without positive autoantibodies will not be confirmed or referred to follow up
  2. Participants with only one positive autoantibody, will be referred to perform regular follow up as part of routine medical care according to the international consensus guidelines published in July 2024
Positive result at the autoantibodies screening test

Participants with two or more positive autoantibodies:

  1. will be invited to perform a confirmation test as part of the study
  2. If confirmed as having pre-symptomatic type 1 diabetes (T1D) (stages 1 / 2), participants will be referred to complete an educational program emphasizing on DKA prevention and to perform regular follow-up according to the international consensus guidelines published in July 2024, as part of routine medical care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort
Time Frame: End of screening, 3 years after obtaining the first screening test
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
Time Frame: End of screening, 3 years after obtaining the first screening test
End of screening, 3 years after obtaining the first screening test
>500 individuals with pre-clinical Type 1 Diabetes identified in the cohort
Time Frame: End of screening, 3 years after obtaining the first screening test
End of screening, 3 years after obtaining the first screening test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Moshe Phillip, Prof., Schneider Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

February 15, 2028

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0483-24RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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