Early detection of Type 1 diabetes in children and adolescents who have a parent or sibling with Type 1 diabetes
Official title: Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries
Run by Sanofi · NCT07038473 · Data updated 2026-11-12
This project will test a screening process to find pre-symptomatic Type 1 diabetes in kids and teens who have a first-degree relative with Type 1 diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Months to 18 Years |
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 7 sites (Kuwait City, Al Asimah / Capital Governorate and 6 other locations) |
| Status | Recruiting |
| Started | December 17, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07038473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 1.5 to 18 years who are first-degree relatives of a person with Type 1 diabetes and whose parent or legal guardian can provide informed consent are ideal candidates.
✕Probably not a fit
People who already have a diagnosed form of diabetes or a history of insulin treatment are not expected to benefit from this screening approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This protocol offers standardized screening, monitoring, and data collection for young people at increased risk because they have a first-degree relative with Type 1 diabetes. Participation lasts about 13 months and includes two visits: an initial screening visit and a confirmatory follow-up visit. Clinical tests and brief visits are used to identify pre-symptomatic disease and to confirm any findings. The program follows international recommendations for early detection and regional implementation at participating hospitals.
Why it matters
Potential benefit: If successful, the approach could allow earlier diagnosis so families get monitoring, education, and timely care to reduce risk of severe complications.
How similar studies have gone: Similar international screening programs have successfully identified pre-symptomatic Type 1 diabetes in at-risk relatives, though local standardization varies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and adolescents, age 1.5 years to 18 years * First degree relatives of T1D probands * Parent or legal guardian signing an informed consent Exclusion Criteria: * 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.
Where it's running
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Dasman Diabetes Institute - Site Number: 08
Kuwait City, Al Asimah / Capital Governorate, Kuwait Recruiting -
Imam Abdulrahman Bin Faisal University - Site Number: 05
Dammam, Eastern Province, Saudi Arabia Recruiting -
King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01
Jeddah, Mecca Region, Saudi Arabia Recruiting -
King Fahd Medical City - Site Number: 03
Riyadh, Saudi Arabia Recruiting -
King Faisal Specialist Hospital & Research Centre - Site Number: 02
Riyadh, Saudi Arabia Recruiting -
Sheikh Khalifa Medical City - Site Number: 07
Abu Dhabi, United Arab Emirates Recruiting
Show 1 more location
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Sheikh Shakhbout Medical City - Site Number: 06
Abu Dhabi, United Arab Emirates Recruiting
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.