Crohn Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
inflammatory biomarker
Brief summary
Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information. The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity. This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven.
Detailed description
Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information. The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity. This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven
Interventions
DEVICEInflammometer
Patients wear an inflammometer for Photoplethysmography measurements.
Sponsors
NimBio
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. Diagnosis of IBD (Crohn's disease or ulcerative colitis) or IBDU 4. Hospitalized or ambulatory patients with active IBD defined as: 1. HBI ≥ 5, or PMS score ≥3, and 2. Faecal Calprotectin ≥200 μg/g or CRP \> 10 mg/ml, and 3. Access to iOS or Android-based smartphone with internet access 5. Ambulatory patients would be recruited to the study with a gender ratio that will not deviate from a 40:60 ratio in favor of either gender
Exclusion criteria
1. Pregnancy 2. Allergy to steel or elastomer/rubber 3. Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the the PPG signal with any dynamic biomarker | 6 months | Correlation of the inflammatory dynamics (trajectory) as measured by NimBio's technology with any dynamic biomarker in the IBD patient population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Classification of the inflammatory status based on the PPG signal | 6 months | Classification of the inflammatory status as inflamed vs non-inflamed based on NimBio's technology as defined by increase of 1.5-fold over the upper normal limit |
| Correlation of the inflammatory trajectory with the patient's inflammatory status | 6 months | Correlation of the inflammatory trajectory as defined by NimBio's technology with the patient's inflammatory status as assessed by HBI, PRO-2, PMS and SCCAI |
| Classification of the inflammatory status compared to the clinical disease activity | 6 months | Classification of the inflammatory status as inflamed vs non-inflamed based on NimBio's technology compared to the clinical disease activity measured by disease activity questionnaires (where inflammation is defined as HBI\> 5 and PMS\>3). |
| Time of NimBio's indication of a change in the inflammatory status | 6 months | The time of NimBio's indication of a change in the inflammatory status compared with the time of change in the clinical disease score or a physician instructed treatment modification |
| Correlation of the PPG signal with the patient inflammatory status | 6 months | Correlation of the inflammatory dynamics as measured by NimBio's technology with the patient inflammatory status as defined by any dynamic biomarker as compared to each individual biomarker in the overall IBD patient population. |
| Assessment of patient satisfaction | 6 months | Assessment of patient satisfaction about the wearable with PREM questionnaire |
| Assessment of the correlation between the inflammatory status and disease activity | 6 months | Assessment of the correlation between the inflammatory status determined by NimBio's technology and disease activity as measured by endoscopy |
| The effect of the integration of physiological parameters into NimBio's algorithm | 6 months | The effect of the integration of physiological parameters such as pulse rate into NimBio's algorithm as compared to at least one inflammatory biomarker reflecting the patient's inflammatory status |
| Assessment of physiological parameters | 6 months | Assessment of physiological parameters such as pulse rate, as measured by non-invasive measurements |
Countries
Belgium
Contacts
Primary ContactMarc Ferrante, Prof Dr
Backup ContactStefan Delen, Dr
Outcome results
None listed