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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative result at the first autoantibodies screening test | Participants will be invited to repeat the screening test at the age of 2-5 years old | ||
| Positive result at the first or second autoantibodies screening test |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of presymptomatic type 1 diabetes | Presymptomatic type 1 diabetes, defined as positive for 2 or more islet autoantibodies (GADA, IA-2A, and IAA) or those with high levels of a single antibody in both the screening and confirmation samples or in the screening sample plus a diagnosis of diabetes prior to obtaining the conformation sample. Presymptomatic type 1 diabetes will be classified as stage 1, 2, or 3:
| End of screening and follow-up period-4 years after obtaining the first screening test |
| Frequency of Diabetic Ketoacidosis on the clinical presentation of Type 1 Diabetes | End of screening and follow-up period-4 years after obtaining the first screening test |
| Measure | Description | Time Frame |
|---|---|---|
| The average age of islet autoantibody seroconversion | End of screening and follow-up period-4 years after obtaining the first screening test | |
| The rate of islet autoantibody seroconversion | End of screening and follow-up period-4 years after obtaining the first screening test |
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Inclusion Criteria:
Exclusion Criteria:
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Children from the general population of all over Israel, aged 9 months-5 years arriving to the routine blood test for CBC or to any other routine visit to the community pediatrician.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Phillip, Prof | Contact | 972-544-795-995 | moshe.phillip@phillipmd.com | |
| Alona Hamou, MSc | Contact | 972-545-950-277 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Schneider Children's Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Recruiting | Beersheba | Israel |
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| The rate of progression from pre-symptomatic T1D to clinical diabetes | End of screening and follow-up period-4 years after obtaining the first screening test |
| Rambam Medical Center | Not yet recruiting | Haifa | Israel |
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| Hadassah medical Center | Not yet recruiting | Jerusalem | Israel |
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| Child Health Centers all over Israel (clalit Health Services) | Recruiting | Petah Tikva | Israel |
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| Schneider Children Medical Center of Israel | Recruiting | Petah Tikva | Israel |
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| Sheba Medical Center | Not yet recruiting | Ramat Gan | Israel |
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| Dana-Duek children's hospital | Not yet recruiting | Tel Aviv | Israel |
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