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Inflammatory Bowel Disease (IBD)BYODNCT07647640

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

An observational study of Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Maastricht University Medical Center at 3 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Wearing their own wearable device.
Type of treatment
Medical device
How many people
600 participants
Where
3 sitesNetherlands
Study dates
4 Aug 2026to 15 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients from MyIBDCoach, IBDream cohort and IBDthuis (Luscii cohort) with ulcerative colitis or Crohn's Disease.

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

E Godecharle, MD contact

+31 43 388 50 65

eline.godecharle@maastrichtuniversity.nl

Netherlands3 sites, 3 recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch

    TEH Romkens, MD, PhD, +3173-5533735, t.romkens@jbz.nl

    TEH Romkens, MD, PhD

    Recruiting

  • Maastricht UMC+

    Maastricht

    E Godecharle, MD, +31 43 388 50 65, eline.godecharle@maastrichtuniversity.nl

    MJ Pierik, Prof. Dr.

    Recruiting

  • Franciscus Hospital

    Rotterdam

    R West, MD, PhD, +31104616895, r.west@franciscus.nl

    R West, MD, PhD

    Not yet recruiting

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
Wearing their own wearable device.
Keywords
Inflammatory Bowel Disease, Digital biomarkers, Heart rate variability
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wearing their own wearable device.Device

    Wearing their own wearable device.

Study groups in NCT07647640
Study groupRoleWhat they receive
Patients with IBD≥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.
Receives: Device: Wearing their own wearable device.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (6)

  1. 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.

    Measured: 1 year

  2. Identification of a discrepancy between inflammatory flares and symptomatic flares (MIAH-CD>3.6 and MIAH-UC>3.5) regarding HRV.

    Measured: 1 year

  3. To study the inter-device variability in mean HRV metrics (including MESOR, acrophase, amplitude, SDNN, RMSSD), PA and sleep parameters, compared to resting state.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. To study the difference in step count measured by smartwatches compared with smartphones.

    Measured: 1 year

  6. To investigate if changes in HRV, PA and sleep relative to baseline predict clinical/symptomatic remission in IBD.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start4 Aug 2026
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07647640
Sponsor's protocol ID
METC 2025-0463-A-1
Acronym
BYOD
Status last verified
Oct 2026
First submitted
9 Jun 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.2020.04.038. Epub 2020 Apr 23.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 39826619

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Maastricht University Medical Center at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact E Godecharle, MD (+31 43 388 50 65, eline.godecharle@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07647640, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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