Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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:

* Collection of ePRO
* Intelligent analysis and alerts
* Adapted care

Conditions

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IBD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention/Treatment

Group Type EXPERIMENTAL

GutyCare

Intervention Type DEVICE

Device : GutyCare The participants will use GutyCare remote patient monitoring.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GutyCare

Device : GutyCare The participants will use GutyCare remote patient monitoring.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before enrolment
* Initiating an advanced therapy (i.e., biologic therapy or small molecule) OR occurrence of a substantial change in the treatment of the disease.
* Active disease.

Exclusion Criteria

* Patients with altered intestinal continuity or function due to major abdominal surgery (e.g., stoma, extensive resection, anastomosis), uncontrolled intra-abdominal abscess, or active perianal disease.
* Patients for whom digestive surgery is expected during the study period.
* Patients unable or unwilling to use or already using GutyCare.
* Vulnerable individuals as defined by French law.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No