Type 1 Diabetes
Conditions
Brief summary
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).
Interventions
PROCEDUREInvestigational 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.
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis | 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 |
| Refusal rate - ratio of patients proposed for screening who did not accept autoantibody testing and follow-up monitoring | At Baseline (screening visit) | — |
| Acceptance rate - ratio of patients proposed for screening who accepted autoantibody testing and follow-up monitoring | At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit) | — |
Countries
Kuwait, Saudi Arabia, United Arab Emirates
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed