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

NCT ID: NCT07038473

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-25

Study Completion Date

2026-12-25

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Investigational Procedure

Intervention Type 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.

Interventions

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Investigational 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Trial Transparency email recommended (Toll free for US & Canada)

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Other Identifiers

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U1111-1319-5409

Identifier Type: REGISTRY

Identifier Source: secondary_id

PIR18651

Identifier Type: -

Identifier Source: org_study_id