Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: t
View:
• Children and adolescents, age 1.5 years to 18 years
• First degree relatives of T1D probands
• Parent or legal guardian signing an informed consent
Locations
Other Locations
Saudi Arabia
King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01
RECRUITING
Jeddah
United Arab Emirates
Sheikh Shakhbout Medical City - Site Number: 06
RECRUITING
Abu Dhabi
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2026-12-25
Participants
Target number of participants: 3500
Treatments
Other: Children, adolescents and first-degree relatives of T1D probands
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
Related Therapeutic Areas
Sponsors
Leads: Sanofi