Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
ADIR
1 other identifier
observational
50,000
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 4, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
October 17, 2024
October 1, 2024
6 years
April 4, 2021
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (3)
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
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
Study Arms (2)
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
* 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.
Eligibility Criteria
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.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (7)
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Hadassah medical Center
Jerusalem, Israel
Child Health Centers all over Israel (clalit Health Services)
Petah Tikva, Israel
Schneider Children Medical Center of Israel
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Dana-Duek children's hospital
Tel Aviv, Israel
Study Officials
- STUDY DIRECTOR
Moshe Phillip, Prof
Schneider Children's Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2021
First Posted
April 8, 2021
Study Start
April 1, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
October 17, 2024
Record last verified: 2024-10