Multiple Digital Biomarkers for Optimization of IBD Care

N/ANot Yet RecruitingNCT07159776

Imelda GI Clinical Research Center80 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

monitoring of wearable data, shopping data, biomarkers and patient reported outcomesDEVICE

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 one of the Colruyt Group stores. He/she will always need to offer the loyalty card to the cashier prior to payment. The purchase receipt will then be automatically sent to the central food data repository at the sponsor set up for this study. Non-food or non-food related data will neither be captured nor stored during the trial. 3. biomarkers in blood and feaces will be monitored according to standard of care 4. patient reported outcomes will be monitored according to standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Imelda General Hospital

Bonheiden, Belgium

Outcomes

Primary Outcomes

Proportion of patients in which a flare can be detected based on passive monitoring data.

Time frame: 1 year

Secondary Outcomes

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

Central Contacts

Peter Bossuyt, MD PhD

CONTACT

+32 15 50 56 91 peter.bossuyt@imelda.be

Lieven Pouillon, MD

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.