Actively Recruiting
A National Screening Program for Islet Autoantibodies Among First-degree Relatives of Type 1 Diabetes Patients
Led by Rabin Medical Center · Updated on 2025-05-20
20000
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a national screening program to detect the presence of islet autoantibodies (IA) among first-degree relatives of people with type 1 diabetes (T1D). The goal is to identify individuals with pre-clinical stages of T1D (stages 1 and 2) and help prevent diabetic ketoacidosis (DKA) at the time of clinical diagnosis. Screening focuses on four specific autoantibodies: GADA, IA-2A, IAA, and ZnT8A, using the ADAP assay. Confirmatory testing is done for those with two or more positive autoantibodies using additional methods such as ELISA and RIA. Participants without positive autoantibodies are not followed further, while those with only one positive antibody will be referred for routine medical follow-up based on international guidelines. Those with two or more positive autoantibodies will undergo confirmation testing and, if pre-symptomatic T1D is confirmed, will be referred to an educational program focused on DKA prevention and regular follow-up care. This observational study tracks progression from early stages of T1D through clinical diagnosis and DKA events. Throughout the study, participants will be screened once at entry, and cases of stage 2 and 3 diabetes and DKA will be documented. The primary outcome is the prevalence of multiple autoantibodies in this population over three years. Secondary outcomes include the rate of progression through T1D stages and the occurrence of DKA at diagnosis. The study involves ongoing monitoring and data collection over a three-year period following the initial screening.
CONDITIONS
Brief Title
A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 45 years
- First-degree relative of a person with Type 1 Diabetes
- Signed informed consent to participate
You will not qualify if you...
- Known diagnosis of any type of diabetes (type 1, type 2, MODY)
- Previous treatment with insulin or oral diabetes medications
- Current use of systemic immunosuppressive agents (topical and inhaled medications are allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for autoantibody screening test
Duration - Up to 3 years after the initial screening test
Participants with negative or single positive autoantibody results are observed and referred to routine medical care for follow-up according to international guidelines.
Regular follow-up visits as part of routine medical care
Duration - Up to 3 years after the initial screening test
Participants with two or more positive autoantibodies are invited for confirmation testing and, if confirmed, referred to educational programs and routine follow-up care emphasizing diabetic ketoacidosis prevention.
Confirmation test visit plus regular follow-up visits as part of routine medical care
Trial Site Locations
Total: 1 location
1
Schneider Children Medical Center of Israel
Petah Tikva, Israel
Actively Recruiting
Research Team
M
Moshe Phillip, Prof.
A
Alona Hamou, Msc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here