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NCT Number: NCT07038473

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

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01, Jeddah, Mecca Region, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Procedure

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: At Baseline (screening visit)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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