Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy (GC-102)

Resilience

Status and phase

Not yet enrolling

Phase 3

Conditions

IBD

Treatments

Device: GutyCare

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07043036

2024-A02005-42 (ID RCB) (Other Identifier)

GC-102

Details and patient eligibility

About

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.

Full description

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

Enrollment

116 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.