Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy
GC-102
2 other identifiers
interventional
116
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 29, 2025
June 1, 2025
2 years
June 11, 2025
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of on-site IBD-related visits
12 months
Secondary Outcomes (3)
Clinical remission without corticosteroids
12 months
Patients' disease activity
12 months
Improvement in quality of life
12 months
Other Outcomes (2)
Experience from patients
12 months
Experience from HCP
12 months
Study Arms (2)
Intervention/Treatment
EXPERIMENTALControl
NO INTERVENTIONInterventions
Device : GutyCare The participants will use GutyCare remote patient monitoring.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Resiliencelead
- Sanoiacollaborator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 29, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 29, 2025
Record last verified: 2025-06