Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus

Recruiting now

Conditions studied: Type1diabetes

In brief

A national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodies.Up to 50,000 Children will be screened by their primary care physician all over Israel. The initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for CBC ) and repeated at ages 2-5 years. Antibodies will be measured in capillary blood samples using the Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. By using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology. In addition, multiple antibodies will be also measured using a radio-binding assay (RBA) of a venous blood sample for investigational purpose only. Children with confirmed multiple antibodies (stage 1 or 2 T1D) will be followed up routinely for the appearance of clinical signs of diabetes (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. This program will include diabetes education emphasizing on DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. The analysis and storage of the samples will be done in a single screening center at Schneider Children's Medical Center of Israel.

Key facts

Study ID

NCT04834518

Run by

Rabin Medical Center

People needed

50000

Starts

2021-04-01

Expected to finish

2027-03-31

Last updated by the study team

2024-10-17

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any trial-related activities
• Children aged 9-months- 5 years at first screening.

You may not qualify if…

• Known diagnosis of diabetes (Type 1 or other)

Where it is running

• Child Health Centers all over Israel (clalit Health Services) — Petah Tikva, Israel (enrolling)
• Soroka Medical Center — Beersheba, Israel (enrolling)
• Schneider Children Medical Center of Israel — Petah Tikva, Israel (enrolling)
• Sheba Medical Center — Ramat Gan, Israel
• Dana-Duek children's hospital — Tel Aviv, Israel
• Rambam Medical Center — Haifa, Israel
• Hadassah medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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