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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02005-42 (ID RCB) | Other Identifier | Agence Nationale de Sécurité du Médicament (ANSM) |
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| Name | Class |
|---|---|
| Sanoia | OTHER |
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This clinical trial aims to evaluate whether GutyCare, a digital remote patient monitoring (RPM) solution, can enhance organizational outcomes while maintaining non-inferior clinical results in patients with inflammatory bowel disease (IBD) who are initiating or undergoing significant modifications in advanced therapy.
The study compares standard care to an intervention involving the use of GutyCare, a mobile application that collects patient-reported outcomes related to symptoms.
When clinically significant symptoms are identified, alerts are transmitted to the care team, facilitating timely and personalized therapeutic adjustments.
GutyCare is a digital medical device (dMD, CE marked, class IIa) that enables the remote monitoring of patients diagnosed with Inflammatory Bowel Disease (IBD). GutyCare is a software medical device prescribed by gastroenterologists to collect electronic patient-reported outcomes (ePRO). The workflow of GutyCare includes the following steps:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/Treatment | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GutyCare | Device | Device : GutyCare The participants will use GutyCare remote patient monitoring. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of on-site IBD-related visits | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission without corticosteroids | 12 months | |
| Patients' disease activity | PRO-2 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Experience from patients | Dedicated questionnaire for patients. | 12 months |
| Experience from HCP | Dedicated questionnaire for HCP. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Resilience | Contact | +33 805 69 65 61 | support@gutycare.com |
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| Improvement in quality of life |
SIBDQ |
| 12 months |