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

Sanofi3,500 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

3,500

Conditions

Type 1 Diabetes

Interventions

Investigational ProcedurePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (2)

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

Jeddah, Mecca Region, Saudi Arabia

RECRUITING

Sheikh Shakhbout Medical City - Site Number: 06

Abu Dhabi, United Arab Emirates

RECRUITING

Outcomes

Primary Outcomes

Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D

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

Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)

Secondary Outcomes

Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis

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

Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)

Refusal rate - ratio of patients proposed for screening who did not accept autoantibody testing and follow-up monitoring

Time frame: At Baseline (screening visit)

Acceptance rate - ratio of patients proposed for screening who accepted autoantibody testing and follow-up monitoring

Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)

Central Contacts

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

CONTACT

800-633-1610 Contact-US@sanofi.com

Data from ClinicalTrials.gov

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