Clinical trial Recruiting at 3 sites Observational Ages 9 Months to 5

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.

More Type1diabetes trials

Quick facts

Study typeObservational
Ages9 Months to 5 Years
SexAll
Enrollment50000 (estimated)
SponsorRabin Medical Center
Academic / other
Locations7 sites (Beersheba and 6 other locations)
StatusRecruiting
StartedApril 1, 2021
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedOctober 17, 2024
Trial IDNCT04834518 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

  • 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
  • Dana-Duek children's hospital
    Tel Aviv, Israel
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.