Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study (BYOD)

Maastricht University Medical Centre (MUMC)

Status: Not yet enrolling

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Device: Wearing their own wearable device.

Study type: Observational

Funder types: Other

Identifiers

NCT07647640

METC 2025-0463-A-1

Details and patient eligibility

About

The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.

Full description

IBD, comprising Crohn's disease and ulcerative colitis, is a chronic inflammatory condition of the gastrointestinal tract, with a globally rising prevalence. Current medical care consists of outpatient visits combined with blood and stool tests, radiological examination and endoscopy. The disease is costly to manage, also leading to indirect costs such as reduced work productivity. Telemonitoring platforms, including MyIBDCoach, IBD@home(Luscii) and IBDream, can alleviate these factors by enabling remote cost-effective monitoring of patient's health. However, data collection largely relies on burdensome questionnaires which are susceptible to bias. Emerging technologies such as wearable devices and smartphones enable continuous remote monitoring through digital biomarkers. This Bring Your Own Device (BYOD) study is part of the IBDigital project, which aims to enrich existing monitoring platforms by integrating digital biomarkers.

In this prospective, observational, multicenter cohort study, patients with IBD will be recruited from the outpatient clinics of the participating centers. Data will be collected from participants' personal smartwatches (and smartphones). Following an inclusion period of approximately four months, participants will enter a one-year follow-up period. During follow-up, standard-of-care clinical data will be collected during outpatient visits. In addition, wearable-derived data, including heart rate metrics, sleep parameters, and physical activity measures, will be continuously collected.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Crohn's Disease or ulcerative colitis
• Having a smartwatch and/or a smartphone
• Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)

Exclusion criteria

• No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...

Trial design

600 participants in 1 patient group

Patients with IBD

Description:

≥18 years or older with Crohn's disease or ulcerative colitis, and having a smartwatch (Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available) ) and/or a smartphone.

Treatment:

Device: Wearing their own wearable device.