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NCT04834518: ADIR

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

Recruiting now Last updated 17 October 2024
What this trial tests

trial in Type1diabetes in 50,000 participants. Currently enrolling.

Timeline
1 April 2021
Primary endpoint
31 March 2027
31 March 2027

Quick facts

Lead sponsorRabin Medical Center
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment50,000
Start date1 April 2021
Primary completion31 March 2027
Estimated completion31 March 2027
Sites7 locations across Israel

Conditions studied

Sponsor

Rabin Medical Center

Who can join

Adults 9 Months to 5, any sex, with Type1diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Type1diabetes

Currently open trials in the same condition.

Other Rabin Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04834518.

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