Real-Time, Non-Invasive Monitoring of IBD Inflammatory Biomarkers with the IBD AWARE® Wearable Device
Published: 05/24/2024
General Information:
The purpose of this study is to continuously monitor a patient's IBD biomarkers with the non-invasive IBD AWARE® wearable device to determine its effectiveness in monitoring IBD inflammation. We also aim to understand how these inflammatory biomarkers relate to your symptoms. By participating, you'll help us enhance the way we monitor and manage IBD.
Eligibility:
Inclusion criteria:
- Over the age of 18
- Diagnosed with Crohn's disease or Ulcerative Colitis
- Ability to provide informed consent
- Willing to provide blood, saliva, and stool samples as part of the study
- Confirmed by either laboratory testing or imaging evidence of colon inflammation in the past 3 months.
- Currently being treated with biologic therapy for your IBD (such as, but not limited to: anti-TNFα, anti-IL-23, or other Integrin therapies.
- Agree to share information about current medication dosage and timing.
- Ability to use and interact with the IBD AWARE® iPhone or Android app and devices
Exclusion criteria:
- Known pregnancy or currently lactating women
- Current malignancy or active treatment for previously diagnosed malignancy
- Patients with squamous and basal cell cancer of the skin are still eligible for the study
- Serious co-morbidity including:
- Immunodeficiency
- Recent myocardial infarction (in the past 3 months)
- History of renal or hepatic failure or sepsis
- Regular use of antidiarrheal agents
- Presence of an active obstruction or a penetrating complication (i.e., abscess, phlegmon)
- Any active infection
Study Details:
This is a 4-week study where participants will be asked to wear the non-invasive IBD AWARE® monitoring device continuously for four days each week and answer a daily survey about their IBD symptoms on a mobile app. Participants will also be asked to provide blood and stool samples with the specifics determined by your study site. People with IBD typically experience chronic episodes of inflammation in the gastrointestinal tract that lead to pain and swelling. The purpose of this study is to learn if continuously and non-invasively monitoring a patient’s inflammatory biomarkers in sweat can be used to remotely monitor IBD inflammation.
Description of treatment or intervention
IBD AWARE® is a wearable wellness platform consisting of:
- A wearable device utilizing passive-sweat sensing technology
- SWEAT AWARE® software for data analysis and wellness insights/visualization
- Non-invasive tracking of wellness indicators relating to digestive/gut health
- Continuous, Non-Invasive Inflammation Monitoring device that measures C-reactive protein (CRP) and Claprotectin and other biomarkers through innovative passive-sweat sensor technology.
IBD AWARE® is not cleared by the Food and Drug Administration (FDA) as a medical device and therefore is categorized as RUO (Research Use Only) / IUO (Investigational Use Only) in clinical studies. Using IBD AWARE® during this study will not impact your routine care. For the latest on the regulatory status, please see https://www.enlisense.com/ibdaware.
Patient Participation Requirements
Your participation in this research will last 4 weeks, during which you will be asked to wear the non-invasive IBD AWARE® device continuously for seven days each week and answer surveys about your IBD symptoms. Participants will also be asked to provide blood, saliva, and stool samples and share information about their IBD care, medication and treatment details, collected from your medical records and through conversations with the research team.
Please contact [email protected] for more details.
Possible risks and side effects:
This study is no greater than minimal risk. No change in treatment will be made as part of the study. The study device will not be used to direct patient care. IBD AWARE® Risks: There are no adverse events expected with the use of IBD AWARE® in this study. Results will not be used to direct clinical care.
Being in this study will not help you directly. You may choose not to participate if you have concerns about the risks involved. The main risks of participating in this study include loss of confidentiality and risks associated with drawing blood. Risks of drawing blood include pain, discomfort, bleeding, bruising, swelling or redness at the needle insertion site, infection, dizziness, and a rare risk of fainting or other problems. For a complete description of risks, refer to the Detailed Consent Section.