A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients (ADIR Families)

Clalit Health Services

Status: Enrolling

Conditions: Type 1 Diabetes; Autoantibodies Screening

Study type: Observational

Funder types: Other

Identifiers

NCT06665815

0483-24RMC

Details and patient eligibility

About

A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 & 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA.

A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA.

Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 2 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 2-45 years
• First-degree relatives of Type 1 Diabetes probands
• Signing an informed consent

Exclusion criteria

• Known diabetes of any kind (type 1, type 2, MODY)
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Trial design

20,000 participants in 2 patient groups

Negative result at the autoantibodies screening test

Description:

1. Participants without positive autoantibodies will not be confirmed or referred to follow up 2. Participants with only one positive autoantibody, will be referred to perform regular follow up as part of routine medical care according to the international consensus guidelines published in July 2024

Positive result at the autoantibodies screening test

Description:

Participants with two or more positive autoantibodies: 1. will be invited to perform a confirmation test as part of the study 2. If confirmed as having pre-symptomatic type 1 diabetes (T1D) (stages 1 / 2), participants will be referred to complete an educational program emphasizing on DKA prevention and to perform regular follow-up according to the international consensus guidelines published in July 2024, as part of routine medical care