Clinical trial NCT04834518: Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Official title: Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type1diabetes
Keywords: autoantibodies screening
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2021-04-08
Enrollment: 50000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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)

Primary outcomes:
measure: Diagnosis of presymptomatic type 1 diabetes
timeFrame: End of screening and follow-up period-4 years after obtaining the first screening test
measure: Frequency of Diabetic Ketoacidosis on the clinical presentation of Type 1 Diabetes
timeFrame: End of screening and follow-up period-4 years after obtaining the first screening test
Secondary outcomes:
measure: The average age of islet autoantibody seroconversion
timeFrame: End of screening and follow-up period-4 years after obtaining the first screening test
measure: The rate of islet autoantibody seroconversion
timeFrame: End of screening and follow-up period-4 years after obtaining the first screening test
measure: The rate of progression from pre-symptomatic T1D to clinical diabetes
timeFrame: End of screening and follow-up period-4 years after obtaining the first screening test
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah medical Center
city: Petach-Tikva
country: Israel
facility: Schneider Children Medical Center of Israel
city: Petah-Tikva
country: Israel
facility: Child Health Centers all over Israel (clalit Health Services)
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Dana-Duek children's hospital
Study officials:
affiliation: Schneider Children's Medical Center
name: Moshe Phillip, Prof
role: STUDY_DIRECTOR
References: