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Not yet recruiting NCT07159776

Multiple Digital Biomarkers for Optimization of IBD Care

— Observational Crohn Disease (CD) Ulcerative Colitis (UC) Inflammatory Bowel Disease (IBD)

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: monitoring of wearable data, shopping data, biomarkers and patient reported outcomes.
Who it may be relevant to
Registry conditions: Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD). 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
Belgium
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

To develop digital biomarkers associated with disease activity of inflammatory bowel disease

Detailed description

The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, grocery shopping data, patient reported outcome data, laboratory data and technical exam data. A model will be build that predict disease activity in IBD.

Interventions

  • Device monitoring of wearable data, shopping data, biomarkers and patient reported outcomes
    1. All participants will receive a wearable device type Corsano Health Cardio watch 287-2 which is provided by the sponsor via Inovigate. Participants will be encouraged to wear the device 24h per day and need to wear the wearable device at least 12 hours per day, preferential during daytime. 2. All participants will receive a loyalty card (Xtra card Colruyt group) which is provided by the sponsor via Inovigate for food data capturing. The patient is requested to execute all grocery shopping at

Primary outcome measures

  • Proportion of patients in which a flare can be detected based on passive monitoring data. [Time frame: 1 year]
Secondary outcome measures (5)
  • Proportion of patients in which a biomarker flare can be detected based on passive monitoring data [Time frame: 1 year]
  • Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring [Time frame: 1 year]
  • Proportion of patients in which a flare can be detected based on food purchase data [Time frame: 1 year]
  • Proportion of patients in which a biomarker flare can be detected based on food purchase data [Time frame: 1 year]
  • Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on food purchase data [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Males or females aged > 18 years
  • Diagnosis of CD, UC or IBD-unspecified for at least 1 month
  • Treatment with conventional or advanced therapy for IBD at initiation of the study
  • The patient must have access to an email address
  • The patient must be willing to perform all the groceries shopping at any of the Colruyt Group stores during this study, using an Xtra card created by the study team.
  • Capacity to independently answer regular digital questionnaires
  • Capacity and willingness to use a smartphone and activity tracker

Exclusion criteria

  • Planned extended (> 1 month) overseas travel during the study period of 12 months, if internet access would be impossible, inconvenient or unaffordable during this time
  • Previous colectomy
  • Inability to communicate well with investigators or unable to comply with the study requirements
  • Significant medical condition interfering with physiological measurements trough a wearable device (heart failure, pacemaker or defibrillator)
  • Inclusion or planned inclusion in an interventional IBD-related clinical trial

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

Belgium · 1 center
  • Imelda General Hospital — Bonheiden

Publications

  • 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
  • Ghosh S, Louis E, Beaugerie L, Bossuyt P, Bouguen G, Bourreille A, Ferrante M, Franchimont D, Frost K, Hebuterne X, Marshall JK, O'Shea C, Rosenfeld G, Williams C, Peyrin-Biroulet L. Development of the IBD Disk: A Visual Self-administered Tool for Assessing Disability in Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2017 Mar;23(3):333-340. doi: 10.1097/MIB.0000000000001033. PMID 28146002
  • Rowan C, Hirten R. The future of telemedicine and wearable technology in IBD. Curr Opin Gastroenterol. 2022 Jul 1;38(4):373-381. doi: 10.1097/MOG.0000000000000845. PMID 35762696
  • Singh B, Chastin S, Miatke A, Curtis R, Dumuid D, Brinsley J, Ferguson T, Szeto K, Simpson C, Eglitis E, Willems I, Maher C. Real-World Accuracy of Wearable Activity Trackers for Detecting Medical Conditions: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Aug 30;12:e56972. doi: 10.2196/56972. PMID 39213525
  • Louis S, Lembrechts N, Pouillon L. Towards a Greener IBD-Care: Let's INTERACT! United European Gastroenterol J. 2025 Mar;13(2):276-277. doi: 10.1002/ueg2.12728. Epub 2024 Dec 4. No abstract available. PMID 39632541
  • Pouillon L, Hoefkens E, Verheyen V, Bronswijk M, Van Olmen A, Van Dessel S, Siborgs N, Bossuyt P. Letter to the Editor: Feasibility and Efficiency of an E-Health Preadmission Assessment System for Intravenous Therapy in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Jan 6;26(2):e11-e12. doi: 10.1093/ibd/izz304. No abstract available. PMID 31793628
  • Bossuyt P, Hoefkens E, Pouillon L. Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1839. doi: 10.1016/j.cgh.2018.05.029. No abstract available. PMID 30343866
  • Schoenfeld R, Nguyen GC, Bernstein CN. Integrated Care Models: Optimizing Adult Ambulatory Care in Inflammatory Bowel Disease. J Can Assoc Gastroenterol. 2018 Oct 15;3(1):44-53. doi: 10.1093/jcag/gwy060. eCollection 2020 Feb. PMID 34169226

Identifiers

NCT: NCT07159776 · imelda 202501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗