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

Sanofi

Status: Not yet enrolling

Conditions: Type 1 Diabetes

Treatments: Procedure: Investigational Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT07038473

PIR18651

U1111-1319-5409 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,500 participants in 1 patient group

Children, adolescents and first-degree relatives of T1D probands

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure