An observational study in Type1diabetes, sponsored by Rabin Medical Center. Recruiting at 7 sites in Israel. Open to participants aged 9 Months to 5 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Rabin Medical Center · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 50,000 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants will be invited to repeat the screening test at the age of 2-5 years old
* Participants will be monitored annually for risk of type 1 diabetes. (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) * Families will attend diabetes-educational program emphasizing on DKA prevention * Stress assessment for the families involved and stress alleviating interventions when required.
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: * Stage 1 will be defined as 2 or more islet autoantibodies or high levels of a single antibody and normal glucose tolerance based on OGTT results. (not including patients with only a single antibody who have first degree relative with type 1 diabetes) * Stage 2 will be defined as 1 or more islet autoantibodies accompanied by dysglycemia (fasting plasma glucose of 110-125 mg/dL or impaired 2-hour plasma glucose of 140- 199 mg/dL and/or plasma glucose ≥200 mg/dL at intermediate time points \[30, 60, 90 minutes\]) based on OGTT results. * Stage 3 will be defined according to the American Diabetes Association criteria
Time frame: 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
Time frame: End of screening and follow-up period-4 years after obtaining the first screening test
The average age of islet autoantibody seroconversion
Time frame: End of screening and follow-up period-4 years after obtaining the first screening test
The rate of islet autoantibody seroconversion
Time frame: End of screening and follow-up period-4 years after obtaining the first screening test
The rate of progression from pre-symptomatic T1D to clinical diabetes
Time frame: End of screening and follow-up period-4 years after obtaining the first screening test
Plan to share: Undecided
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