A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
NCT ID: NCT06665815
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2024-12-15
2028-02-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Negative result at the autoantibodies screening test
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
No interventions assigned to this group
Positive result at the autoantibodies screening test
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* First-degree relatives of Type 1 Diabetes probands
* Signing an informed consent
Exclusion Criteria
* Have a previous history of being treated with insulin or oral diabetes medications.
* Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
2 Years
45 Years
ALL
Yes
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Prof.
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
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Schneider Children Medical Center of Israel
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0483-24RMC
Identifier Type: -
Identifier Source: org_study_id
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