Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease
Official title: Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Run by Maastricht University Medical Center · NCT07647640 · Data updated 2026-11-12
This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 3 sites ('s-Hertogenbosch and 2 other locations) |
| Status | Recruiting |
| Started | August 4, 2026 |
| Main results expected | December 15, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07647640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with Crohn's disease or ulcerative colitis who own a smartwatch and/or smartphone and are willing to share wearable and clinical data.
✕Probably not a fit
Patients without access to compatible wearables or with conditions that heavily affect heart rate may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, observational study enrolling adults with inflammatory bowel disease who own a smartwatch or smartphone. Researchers will collect wearable-derived data, including heart rate metrics, sleep, and activity, along with standard clinical information over about a year. The goal is to see if digital biomarkers from personal devices can predict disease flares before they occur, complementing routine care and existing telemonitoring tools. Participants will continue their usual care, with data pulled from electronic records and wearable devices. No new devices are provided by the study, and analysis will include subgroup evaluations based on conditions like heart rhythm issues or medications affecting heart rate.
Why it matters
Potential benefit: If successful, the study could enable earlier detection of flares and more timely treatment adjustments through routine remote monitoring.
How similar studies have gone: Previous work in digital biomarkers and wearable monitoring for IBD suggests potential, but using personal devices for flare prediction in IBD remains exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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...
Where it's running
-
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands Recruiting -
Maastricht UMC+
Maastricht, Netherlands Recruiting -
Franciscus Hospital
Rotterdam, Netherlands Not yet recruiting
Study contacts
- Principal investigator: MJ Pierik, Prof. Dr. — Maastricht UMC
- Study coordinator: E Godecharle, MD
- Email: eline.godecharle@maastrichtuniversity.nl
- Phone: +31 43 388 50 65
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.