Type 1 DiabetesNCT07038473
Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)
A study testing Investigational Procedure in people with Type 1 Diabetes, run by Sanofi at 7 sites in 3 countries.
Trial summary
The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international… Read more about this study
- Who is it for?
- Ages 18 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Investigational Procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 17 Dec 2025to 30 Jun 2027
- Phase
- Interventional
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 18 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescents, age 1.5 years to 18 years
- First degree relatives of T1D probands
- Parent or legal guardian signing an informed consent
Who cannot join
- Already developed clinical overt T1D
- Known diabetes of any kind (type 1, type 2, Maturity Onset Diabetes of the Young - MODY)
- Have a previous history of being treated with insulin
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
7 sites in 3 countries
Saudi Arabia4 sites, 4 recruiting
- Recruiting
Imam Abdulrahman Bin Faisal University - Site Number: 05
Dammam, Eastern Province
- Recruiting
King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01
Jeddah, Mecca Region
- Recruiting
King Fahd Medical City - Site Number: 03
Riyadh
- Recruiting
King Faisal Specialist Hospital & Research Centre - Site Number: 02
Riyadh
United Arab Emirates2 sites, 2 recruiting
- Recruiting
Sheikh Khalifa Medical City - Site Number: 07
Abu Dhabi
- Recruiting
Sheikh Shakhbout Medical City - Site Number: 06
Abu Dhabi
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute - Site Number: 08
Kuwait City, Al Asimah / Capital Governorate
About this study
Official title: Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries
The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).
- Conditions
- Type 1 Diabetes
- Being tested
- Investigational Procedure
- 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.
Investigational ProcedureProcedure or surgery
It consists of prospective blood sample collection from children, adolescents and first-degree relatives of T1D probands.
Study without any Investigational Medicinal Product (IMP) administration.
| Study group | Role | What they receive |
|---|---|---|
| Children, adolescents and first-degree relatives of T1D probands | Other | Blood samples will be collected from the participants and autoantibody testing will be performed. For participants who test positive for any autoantibodies, another autoantibody test and HbA1C test and Oral Glucose Tolerance Test (OGTT) or CGM (Continuous Glucose Monitoring) will be performed Receives: Procedure: Investigational Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D
Stage 1 is defined by the presence of two or more diabetes-related autoantibodies with normoglycemia.
Stage 2 is characterized by the presence of two or more diabetes-related autoantibodies with dysglycemia (impaired fasting glucose or impaired glucose tolerance) but without clinical symptoms of diabetes
Measured: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)
Secondary outcomes (3)
Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis
Stage 3 is defined by the presence of two or more diabetes-related autoantibodies, abnormal blood glucose levels, and clinical symptoms of T1D, such as polyuria, polydipsia, weight loss, and fatigue
Measured: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)
Refusal rate - ratio of patients proposed for screening who did not accept autoantibody testing and follow-up monitoring
Measured: At Baseline (screening visit)
Acceptance rate - ratio of patients proposed for screening who accepted autoantibody testing and follow-up monitoring
Measured: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start17 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038473
- Sponsor's protocol ID
- PIR18651
- Other IDs
- U1111-1319-5409
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org