Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearing their own wearable device..
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Device Wearing their own wearable device.
Wearing their own wearable device.
Primary outcome measures
- Prediction of mucosal inflammation (calprotectin≥250 µg/g and/or CRP≥5mg/l with UCEIS≥1 or Mayo≥1 (UC) and SES CD≥3 (CD) on endoscopic/radiological evaluation) using HRV-changes relative to individual baseline. [Time frame: 1 year]
Secondary outcome measures (6)
- Prediction of mucosal inflammation (assessed by laboratory tests and/or imaging in IBD) using changes in physical activity and sleep metrics relative to individual baseline. [Time frame: 1 year]
- Identification of a discrepancy between inflammatory flares and symptomatic flares (MIAH-CD>3.6 and MIAH-UC>3.5) regarding HRV. [Time frame: 1 year]
- To study the inter-device variability in mean HRV metrics (including MESOR, acrophase, amplitude, SDNN, RMSSD), PA and sleep parameters, compared to resting state. [Time frame: 1 year]
- Investigation of additional digital phenotypes that can be derived from the available (wearable/clinical) data and how these phenotypes differ across relevant subgroups within the study population. [Time frame: 1 year]
- To study the difference in step count measured by smartwatches compared with smartphones. [Time frame: 1 year]
- To investigate if changes in HRV, PA and sleep relative to baseline predict clinical/symptomatic remission in IBD. [Time frame: 1 year]
Eligibility 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...
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 3 centers
- Jeroen Bosch Hospital — 's-Hertogenbosch
- Maastricht UMC+ — Maastricht
- Franciscus Hospital — Rotterdam
Publications
- Leung W, Case L, Jung J, Yun J. Factors associated with validity of consumer-oriented wearable physical activity trackers: a meta-analysis. J Med Eng Technol. 2021 Apr;45(3):223-236. doi: 10.1080/03091902.2021.1893395. Epub 2021 Mar 22. PMID 33750250
- Kaplan GG. The global burden of inflammatory bowel disease: from 2025 to 2045. Nat Rev Gastroenterol Hepatol. 2025 Oct;22(10):708-720. doi: 10.1038/s41575-025-01097-1. Epub 2025 Jul 18. PMID 40681759
- Bossuyt P, De Nollin I, De Moor T, Trekels G, Maes I, Dewulf G, Pouillon L. Inflammation Is a Large Dataset of Heartbeats, Groceries, Night Rest, and More. Gastroenterology. 2025 Oct;169(5):1085-1086. doi: 10.1053/j.gastro.2025.05.029. Epub 2025 Jun 25. No abstract available. PMID 40578576
- de Jong MJ, Boonen A, van der Meulen-de Jong AE, Romberg-Camps MJ, van Bodegraven AA, Mahmmod N, Markus T, Dijkstra G, Winkens B, van Tubergen A, Masclee A, Jonkers DM, Pierik MJ. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1744-1752. doi: 10.1016/j.cgh.2020. PMID 32335133
- de Jong M, van der Meulen-de Jong A, Romberg-Camps M, Degens J, Becx M, Markus T, Tomlow H, Cilissen M, Ipenburg N, Verwey M, Colautti-Duijsens L, Hameeteman W, Masclee A, Jonkers D, Pierik M. Development and Feasibility Study of a Telemedicine Tool for All Patients with IBD: MyIBDcoach. Inflamm Bowel Dis. 2017 Apr;23(4):485-493. doi: 10.1097/MIB.0000000000001034. PMID 28267047
- Hirten RP, Danieletto M, Scheel R, Shervey M, Ji J, Hu L, Sauk J, Chang L, Arnrich B, Bӧttinger E, Dudley J, Keefer L, Sands BE. Longitudinal Autonomic Nervous System Measures Correlate With Stress and Ulcerative Colitis Disease Activity and Predict Flare. Inflamm Bowel Dis. 2021 Oct 18;27(10):1576-1584. doi: 10.1093/ibd/izaa323. PMID 33382065
- Hirten RP, Danieletto M, Sanchez-Mayor M, Whang JK, Lee KW, Landell K, Zweig M, Helmus D, Fuchs TJ, Fayad ZA, Nadkarni GN, Keefer L, Suarez-Farinas M, Sands BE. Physiological Data Collected From Wearable Devices Identify and Predict Inflammatory Bowel Disease Flares. Gastroenterology. 2025 May;168(5):939-951.e5. doi: 10.1053/j.gastro.2024.12.024. Epub 2025 Jan 16. PMID 39826619
Identifiers
NCT: NCT07647640 · METC 2025-0463-A-1