Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus (ADIR)

Clalit Health Services

Status: Enrolling

Conditions: Type1diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT04834518

018620RMC & 18420COM

Details and patient eligibility

About

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.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 9 months to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

50,000 participants in 2 patient groups

Negative result at the first autoantibodies screening test

Description:

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

Description:

* 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.