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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The aim of this study will be to evaluate the feasibility of an autoantibody-based type 1 diabetes screening program for first degree relatives of people living with type 1 diabetes within the province of Quebec. Feasibility of follow-up strategies of "at-risk" individuals will also be assessed.
This project will be divided into two phases, with the aim to evaluate:
Participants will come to the laboratory for blood sample collection, medical history and genetic risk score assessment, as well as anthropometric and cutaneous advanced glycated end (AGE) products measurements. A series of questionnaires will be completed.
After screening results are obtained (i.e., presence or absence of IAbs), a virtual visit will be conducted to communicate results to participants.
A positive result for IAb will warrant a second test for confirmation , using WBD within 3 months of initial screening.
After IAb positivity confirmation, participants will be invited to participate in phase 2 of this project (monitoring). Participants will be given the opportunity to select either a centralized or decentralized path for study monitoring.
Follow-up will be dependent of the stage of T1D:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Centralized approach | Active Comparator | Centralized approach managed and coordinated within the BETTER group based at IRCM (Montreal, Quebec), with standardized processes and integrated care pathways. In this approach, scheduling processes and data collection (clinical visits, laboratory analysis, questionnaires) will be handled by the research team. Participants' healthcare professional will be notified (by postal service and/or email if available) |
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| Decentralized approach | Active Comparator | In this approach, participants will be monitored by their preferred HCP according to consensus-based guidelines for monitoring pre-clinical T1D which will be communicated to both participants and HCPs. Therefore, follow-up and monitoring will be at the discretion of the HCP. However, regular contacts by the research team according to T1D stages will ensure the actual follow-up received. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centralized Monitoring Approach | Behavioral | A semi-annual clinical visit (either by medical or trained staff) will be conducted to collect various data: IAb assessment, HbA1c measure, fasting blood glucose, glucose monitoring and information about eating habits, mental health, menstrual cycle, physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of screening and monitoring outcomes | Percentage of conversion of eligible participants to consent to participating in the study | Through study completion for positive screened participants: 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valérie Boudreau, Ph.D | Contact | 5149703660 | valerie.boudreau@ircm.qc.ca | |
| Maha Lebbar, M.D. | Contact | maha.lebbar@ircm.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, M.D. Ph.D | Institut de Recherches Cliniques de Montreal | Principal Investigator |
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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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| Decentralized Monitoring Approach | Behavioral | Monitored by the participant's preferred local Healthcare Provider (HCP) according to consensus-based guidelines for pre-clinical T1D. The research team does not conduct direct clinical visits; instead, the research team conducts semi-annual phone calls (and initial 1-month or 6-month check-ins depending on T1D stage) to confirm that appropriate HCP follow-up is ongoing, document any clinical assessments conducted by the HCP, and collect the results of those investigations. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |