Screening children for early signs of Type 1 diabetes
Official title: Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Run by Rabin Medical Center · NCT04834518 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 9 Months to 5 Years |
| Sex | All |
| Enrollment | 50000 (estimated) |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 7 sites (Beersheba and 6 other locations) |
| Status | Recruiting |
| Started | April 1, 2021 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 17, 2024 |
| Trial ID | NCT04834518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 9 months to 5 years who have not been diagnosed with diabetes.
✕Probably not a fit
Patients who already have a known diagnosis of diabetes will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with similar screening approaches for autoimmune conditions, indicating potential for this method to be effective.
Who can join: the full rules
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 it's running
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Soroka Medical Center
Beersheba, Israel Recruiting -
Child Health Centers all over Israel (clalit Health Services)
Petah Tikva, Israel Recruiting -
Schneider Children Medical Center of Israel
Petah Tikva, Israel Recruiting -
Rambam Medical Center
Haifa, Israel Not yet recruiting -
Hadassah medical Center
Jerusalem, Israel Not yet recruiting -
Sheba Medical Center
Ramat Gan, Israel Not yet recruiting
Show 1 more location
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.