Type 1 DiabetesADIR FamiliesNCT06665815
A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
An observational study of Type 1 Diabetes and Autoantibodies Screening, run by Rabin Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Autoantibodies Screening
- How many people
- 20,000 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2024to 15 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: First degree relatives of patients with Type 1 diabetes from all over Israel, aged 2-45 years old
Who may be able to join
- Age 2-45 years
- First-degree relatives of Type 1 Diabetes probands
- Signing an informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children Medical Center of Israel
Petah Tikva
Alona Hamou, MSc, 972-545-950-277, alonah@clalit.org.il
Moshe Phillip, Prof
About this study
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.
- Conditions
- Type 1 Diabetes, Autoantibodies Screening
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel
Measured: End of screening, 3 years after obtaining the first screening test
Secondary outcomes (3)
The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort
Measured: 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
Measured: End of screening, 3 years after obtaining the first screening test
>500 individuals with pre-clinical Type 1 Diabetes identified in the cohort
Measured: End of screening, 3 years after obtaining the first screening test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start15 Dec 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof., Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665815
- Sponsor's protocol ID
- 0483-24RMC
- Acronym
- ADIR Families
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
- ClinicalTrials.gov ID
- NCT06665815
- Acronym / sponsor ID
- ADIR Families / 0483-24RMC
- Conditions
- Type 1 Diabetes, Autoantibodies Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- First degree relatives of patients with Type 1 diabetes from all over Israel, aged 2-45 years old
Key inclusion criteria (3 listed)
- Age 2-45 years
- First-degree relatives of Type 1 Diabetes probands
- Signing an informed consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moshe Phillip, Prof. principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Autoantibodies Screening, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moshe Phillip, Prof. (972-544-795995, moshe.phillip@phillipmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.