Type 1 DiabetesNCT05788341
The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients
An observational study of Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D). Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. 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
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 30 May 2023to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 people with TID
Who may be able to join
- First degree family member (sibling or parent) of a known T1D patient
- Age 2-45 years
- Signing an informed consent
Who cannot join
- Known diabetes of any kind (type 2, MODY)
- Have a previous history of being treated with insulin or oral diabetes medications.
- Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
Trial locations and contacts
1 site in 1 country.
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
We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D).
Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.
- Conditions
- Type 1 Diabetes
- Keywords
- Stage 1 diabetes, stage 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Islet Autoantibodies
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start30 May 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Provention Bio, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788341
- Sponsor's protocol ID
- RMC009523ctil
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05788341
- Acronym / sponsor ID
- RMC009523ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Stage 1 diabetes, stage 2 diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Provention Bio, Inc.
- Study start
- 30 May 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 28 Mar 2023 (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.
We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D).
Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- First degree relatives of people with TID
Key inclusion criteria (3 listed)
- First degree family member (sibling or parent) of a known T1D patient
- Age 2-45 years
- Signing an informed consent
Key exclusion criteria (3 listed)
- Known diabetes of any kind (type 2, MODY)
- Have a previous history of being treated with insulin or oral diabetes medications.
- Currently be 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
Positive Islet Autoantibodies
Time frame: Screening visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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. This study is not recruiting at the moment.
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, 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alona Hamou, Msc (972-545-950277, alonah@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Islet Autoantibodies (time frame: Screening visit). 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 27 Mar 2024.