RecruitingNCT06665815

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

Sponsor

Rabin Medical Center

Enrollment

20,000 participants

Start Date

Dec 15, 2024

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes Autoantibodies Screening

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.

Eligibility

Min Age: 2 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is offering blood tests to the first-degree relatives (parents, siblings, or children) of people with type 1 diabetes to check for autoantibodies — proteins the immune system makes that attack insulin-producing cells in the pancreas. Finding these early warning signs can identify people who may develop type 1 diabetes years before symptoms appear, allowing for earlier intervention. **You may be eligible if...** - You are between 2 and 45 years old - You have a parent, brother, sister, or child with type 1 diabetes - You are willing to sign an informed consent form (or have a parent sign for you) **You may NOT be eligible if...** - You already have any type of diabetes (type 1, type 2, or a rare inherited form) - You have previously taken insulin or oral diabetes medications - You are currently on systemic immune-suppressing medications (inhaled or topical steroids are acceptable) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Schneider Children Medical Center of Israel

Petah Tikva, Israel

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NCT06665815

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