The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT05788341
• Lead Sponsor: Rabin Medical Center

Brief Summary

We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D).

Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Study Start: 2023-05-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• First degree family member (sibling or parent) of a known T1D patient
• Age 2-45 years
• Signing an informed consent

Exclusion Criteria

• Known diabetes of any kind (type 2, MODY)
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently be 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
Positive Islet Autoantibodies	Screening visit

Trial Locations

Locations (1)

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