Screening relatives of people with type 1 diabetes for early islet autoantibodies
Screens relatives of type 1 diabetes patients for antibodies that signal early disease.
Key facts
- Who runs it
- Rabin Medical Center
- Where
- Petah Tikva, IsraelSee the site
- Trial code
- Registry title
- A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
- Status
- Recruiting
- People taking part
- 20,000 people, planned
- Started
- 15 Dec 2024
- Expected to end
- 15 Feb 2028
- Type of study
- Observational, 2 groups
- Record updated
- 20 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and adults aged 2 to 45 who are first-degree relatives of people with type 1 diabetes. It tests their blood for islet autoantibodies.
- Age
- 2 to 45 years
- Sex
- All sexes can join.
- Earlier treatment
- People cannot have been treated before with insulin or oral diabetes medicines.
Main reasons for not taking part
- Known diabetes of any kind (type 1, type 2, MODY)
- Previous treatment with insulin or oral diabetes medicines
- Currently using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Age 2-45 years
- First-degree relatives of Type 1 Diabetes probands
- Signing an informed consent
Who cannot take part
- Have a previous history of being treated with insulin or oral diabetes medications
- Known diabetes of any kind (type 1, type 2, MODY)
- Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 45 years old?
Where in Israel
- Schneider Children Medical Center of IsraelPetah Tikva, IsraelContact: Alona Hamou, MScTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- 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
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
- Plain-language title
- Screening relatives of people with type 1 diabetes for early islet autoantibodiesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06665815, who can take part
- Record updated
- 20 May 2025