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

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT07038473
• Lead Sponsor: Sanofi

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-18
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D	At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)	Stage 1 is defined by the presence of two or more diabetes-related autoantibodies with normoglycemia.; Stage 2 is characterized by the presence of two or more diabetes-related autoantibodies with dysglycemia (impaired fasting glucose or impaired glucose tolerance) but without clinical symptoms of diabetes

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis	At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)	Stage 3 is defined by the presence of two or more diabetes-related autoantibodies, abnormal blood glucose levels, and clinical symptoms of T1D, such as polyuria, polydipsia, weight loss, and fatigue
Refusal rate - ratio of patients proposed for screening who did not accept autoantibody testing and follow-up monitoring	At Baseline (screening visit)
Acceptance rate - ratio of patients proposed for screening who accepted autoantibody testing and follow-up monitoring	At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)