Clinical trial Recruiting at 7 sites Interventional Ages 18 Months to 18

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.

More Type 1 Diabetes trials

Quick facts

Study typeInterventional
Ages18 Months to 18 Years
SexAll
Enrollment3500 (estimated)
SponsorSanofi
Industry-sponsored
Locations7 sites (Kuwait City, Al Asimah / Capital Governorate and 6 other locations)
StatusRecruiting
StartedDecember 17, 2025
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedOctober 23, 2026
Trial IDNCT07038473 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

  • 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
  • Sheikh Shakhbout Medical City - Site Number: 06
    Abu Dhabi, United Arab Emirates
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.