National screening for islet autoantibodies in relatives of type 1 diabetes patients
A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
This study is testing a screening program for family members of people with type 1 diabetes to see if they have certain autoantibodies that could mean they are at risk of developing the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 2 Years to 45 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT06665815 on ClinicalTrials.gov |
What this trial studies
This program aims to screen first-degree relatives of individuals with type 1 diabetes for the presence of islet autoantibodies, which can indicate pre-clinical stages of the disease. Participants aged 2-45 will be tested for four specific autoantibodies using the ADAP assay, and those with positive results will undergo confirmation testing. The goal is to identify individuals at risk for developing type 1 diabetes and provide them with educational resources to prevent diabetic ketoacidosis (DKA). This observational study will help in understanding the progression of type 1 diabetes in at-risk populations.
Who should consider this trial
Good fit: Ideal candidates are first-degree relatives of individuals with type 1 diabetes, aged between 2 and 45 years.
Not a fit: Patients with known diabetes or those currently using systemic immunosuppressive agents will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to early identification and intervention for individuals at risk of developing type 1 diabetes, potentially preventing severe complications.
How similar studies have performed: Similar screening programs have shown promise in identifying at-risk individuals, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Petah Tikva
- Schneider Children Medical Center of Israel — Petah Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Moshe Phillip, Prof. — Schneider Children's Medical Center
- Study coordinator: Moshe Phillip, Prof.
- Email: moshe.phillip@phillipmd.com
- Phone: 972-544-795995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.