Early detection of Type 1 diabetes in children and adolescents who have a parent or sibling with Type 1 diabetes
Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3500 (estimated) |
| Ages | 18 Months to 18 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 2 sites (Jeddah, Mecca Region and 1 other locations) |
| Trial ID | NCT07038473 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Similar international screening programs have successfully identified pre-symptomatic Type 1 diabetes in at-risk relatives, though local standardization varies.
Eligibility criteria
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 this trial is running
Jeddah, Mecca Region and 1 other locations
- King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01 — Jeddah, Mecca Region, Saudi Arabia (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.