A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-45
SponsorRabin Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Age 2-45 years
First-degree relatives of Type 1 Diabetes probands
Signing an informed consent
Disqualifiers
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
Treatments tested in this trial
- Not listed
Trial groups
20,000 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov