A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
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: Type 1 Diabetes, Autoantibodies Screening. Basic parameters: 2 years — 45 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 →
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Overview
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.
Primary outcome measures
- The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel [Time frame: End of screening, 3 years after obtaining the first screening test]
Secondary outcome measures (3)
- The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort [Time frame: End of screening, 3 years after obtaining the first screening test]
- Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes [Time frame: End of screening, 3 years after obtaining the first screening test]
- >500 individuals with pre-clinical Type 1 Diabetes identified in the cohort [Time frame: End of screening, 3 years after obtaining the first screening test]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Schneider Children Medical Center of Israel — Petah Tikva
Identifiers
NCT: NCT06665815 · 0483-24RMC