Condition: Type1diabetes · Sponsor: Rabin Medical Center
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. Th…
This description comes directly from the study's public registry record.
Moshe Phillip, Prof · 972-544-795-995 · moshe.phillip@phillipmd.com
Alona Hamou, MSc · 972-545-950-277 · alonah@clalit.org.il
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT04834518