Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-18
SponsorSanofi
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children and adolescents, age 1.5 years to 18 years
First degree relatives of T1D probands
Parent or legal guardian signing an informed consent
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Investigational Procedure
Procedure/SurgeryIt consists of prospective blood sample collection from children, adolescents and first-degree relatives of T1D probands. Study without any Investigational Medicinal Product (IMP) administration.
Treatment groups
3,500 Participants
are divided into 1 treatment groupGroup A: Children, adolescents and first-degree relatives of T1D probandsOther 1 intervention
Trial outcomes
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
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
1
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)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) Source ClinicalTrials.gov