Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type1diabetes. Basic parameters: 9 months — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Diagnosis of presymptomatic type 1 diabetes [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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Informed consent obtained before any trial-related activities
- Children aged 9-months- 5 years at first screening.
Exclusion criteria
- Known diagnosis of diabetes (Type 1 or other)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Israel · 7 centers
- Soroka Medical Center — Beersheba
- Rambam Medical Center — Haifa
- Hadassah medical Center — Jerusalem
- Child Health Centers all over Israel (clalit Health Services) — Petah Tikva
- Schneider Children Medical Center of Israel — Petah Tikva
- Sheba Medical Center — Ramat Gan
- Dana-Duek children's hospital — Tel Aviv
Identifiers
NCT: NCT04834518 · 018620RMC & 18420COM