Cure8 trial brief
Wearable-derived digital biomarkers could enable earlier, less burdensome detection of IBD flares and better remote monitoring if they reliably predict mucosal inflammation.
Adults with Crohn's disease or ulcerative colitis who use smartwatches/phones, clinicians involved in IBD monitoring, and researchers working on digital biomarkers or remote monitoring.
This is a prospective, observational "bring your own device" cohort study recruiting adults with Crohn's disease or ulcerative colitis in the Netherlands. Participants will wear their personal smartwatches/smartphones and be followed for about one year while routine clinical data (blood, fecal calprotectin, and endoscopy/radiology when done) are collected.
The primary aim is to predict mucosal inflammation using changes in heart rate variability relative to each participant's baseline. The study is part of the IBDigital project and plans to enroll about 600 patients across multiple centers. Devices listed include Apple Watch, Samsung, Fitbit, Garmin, and Polar; devices are not provided by the study.
The registry notes subgroup analyses for factors that can affect heart rate measures (e.g., arrhythmia, beta-blocker use, pregnancy, shift work). Next steps for readers This is a trial record describing study design and planned outcomes, not results.
People interested in participating should consult the trial listing and contact the study sites for eligibility and enrollment details.
This is a registry trial record (observational, recruiting) describing planned data collection and outcomes; it does not report study results. Heart rate variability can be influenced by medications, cardiac conditions, and lifestyle (noted by the investigators), which the study plans to account for in subgroup analyses.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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