RecruitingNot ApplicableNCT07038473

Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)

Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries


Sponsor

Sanofi

Enrollment

3,500 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

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 recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).


Eligibility

Min Age: 18 MonthsMax Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

Interventions

PROCEDUREInvestigational Procedure

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.


Locations(2)

King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01

Jeddah, Mecca Region, Saudi Arabia

Sheikh Shakhbout Medical City - Site Number: 06

Abu Dhabi, United Arab Emirates

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NCT07038473


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