Screening children for early signs of Type 1 diabetes
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
This study is testing a new way to check if young children in Israel have early signs of Type 1 diabetes by looking for specific antibodies in their blood.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Ages | 9 Months to 5 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 7 sites (Beersheba and 6 other locations) |
| Trial ID | NCT04834518 on ClinicalTrials.gov |
What this trial studies
This observational study aims to screen children aged 9 months to 5 years across Israel for the presence of islet autoantibodies, which are indicators of pre-symptomatic Type 1 diabetes mellitus. Up to 50,000 children will be tested by their primary care physicians, with initial screenings conducted at age 1 and repeated until age 5. The study utilizes an innovative technology called Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) to measure antibodies in capillary blood samples, allowing for earlier detection than current methods. Positive results will be confirmed with additional samples analyzed by the same technology and a radio-binding assay for further validation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 9 months to 5 years who have not been diagnosed with diabetes.
Not a fit: Patients who already have a known diagnosis of diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this screening could lead to earlier diagnosis and intervention for children at risk of developing Type 1 diabetes, potentially improving long-term health outcomes.
How similar studies have performed: Other studies have shown success with similar screening approaches for autoimmune conditions, indicating potential for this method to be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent obtained before any trial-related activities * Children aged 9-months- 5 years at first screening. Exclusion Criteria: * Known diagnosis of diabetes (Type 1 or other)
Where this trial is running
Beersheba and 6 other locations
- Soroka Medical Center — Beersheba, Israel (Recruiting)
- Rambam Medical Center — Haifa, Israel (Not_yet_recruiting)
- Hadassah medical Center — Jerusalem, Israel (Not_yet_recruiting)
- Child Health Centers all over Israel (clalit Health Services) — Petah Tikva, Israel (Recruiting)
- Schneider Children Medical Center of Israel — Petah Tikva, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Not_yet_recruiting)
- Dana-Duek children's hospital — Tel Aviv, Israel (Not_yet_recruiting)
Study contacts
- Study coordinator: Moshe Phillip, Prof
- Email: moshe.phillip@phillipmd.com
- Phone: 972-544-795-995
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.