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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1319-5409 | Registry Identifier | ICTRP |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children, adolescents and first-degree relatives of T1D probands | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01 | Recruiting | Jeddah | Mecca Region | Saudi Arabia |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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) |
| Sheikh Shakhbout Medical City - Site Number: 06 | Recruiting | Abu Dhabi | United Arab Emirates |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |