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

Randomized Controlled Trial Comparing a Strategy Based on Continuous Monitoring at Home Using a Digital Remote Patient Monitoring Solution to Reference Standard in Patients With IBD Initiating an Advanced Therapy or Undergoing a Substantial Change in Their Advanced Therapy.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07043036

Acronym

GC-102

Enrollment

116

Registered

2025-06-29

Start date

2025-06-30

Completion date

2027-06-30

Last updated

2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

Keywords

Remote Patient Monitoring, Digital medicine, GutyCare, Resilience, PRO, Patient-reported Outcomes

Brief summary

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.

Detailed 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

Interventions

DEVICEGutyCare

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number of on-site IBD-related visits	12 months

Secondary

Measure	Time frame	Description
Clinical remission without corticosteroids	12 months	—
Patients' disease activity	12 months	PRO-2
Improvement in quality of life	12 months	SIBDQ

Other

Measure	Time frame	Description
Experience from patients	12 months	Dedicated questionnaire for patients.
Experience from HCP	12 months	Dedicated questionnaire for HCP.

Contacts

Primary ContactResilience

support@gutycare.com+33 805 69 65 61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026