Clinical trial NCT04077203: Biofeedback of Glucose in Non-diabetic Participants
Official title: Biofeedback of Glucose in Non-diabetic Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Biofeedback
Lead sponsor: Klick Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research examines whether biofeedback of glucose (i.e., knowledge of one's own glucose levels) in non-diabetic participants affects their health behaviours (e.g., eating, nutrition, exercise, etc.). This study utilizes wearable continuous glucose (CGM) technology, which provides personalized feedback to participants to allow them to self-monitor their own glucose levels.

Detailed description: The purpose of this research is to examine whether self-monitoring and biofeedback of glucose levels improves health outcomes in non-diabetic participants. All participants will receive a continuous flash glucose monitor (consisting of an adhesive patch sensor and a handheld reader device) to wear for 14 days. Participants will be randomized into one of 2 groups: those receiving biofeedback (the ability to visualize their glucose levels via the handheld device), and the control group (receiving no biofeedback because the handheld device monitor will be occluded with black tape). Participants' objective and self-report health metrics will be measured before and after the 14-day intervention. The goal is to examine whether the biofeedback condition influences any daily activities or physiological measurements compared to the control condition, as a direct result of self-monitoring glucose levels.

Eligibility criteria: Inclusion Criteria:

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Exclusion Criteria:

* Below the age of 18 years
* Diagnosis of any known chronic or acute medical disease (e.g., diabetes, cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
* Diagnosis of any known neurological disease or psychological disorder (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
* Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
* Suspected or confirmed pregnancy
* Currently breastfeeding
* Use of antibiotics in the three months prior to enrollment
* Any person planning to undergo a Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the duration of the study

Primary outcomes:
measure: Weight in kg
timeFrame: 2 weeks
measure: Body Mass Index (BMI)
timeFrame: 2 weeks
measure: Body fat %
timeFrame: 2 weeks
measure: Resting heart rate
timeFrame: 2 weeks
measure: Resting blood pressure (systolic and diastolic)
timeFrame: 2 weeks
measure: Self-reported positive and negative affect
timeFrame: 2 weeks
measure: Self-reported general health
timeFrame: 2 weeks
measure: Self-reported perceived stress
timeFrame: 2 weeks
measure: Self-reported sleep quality
timeFrame: 2 weeks
measure: Self-reported general well-being
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Klick Inc.
state: Ontario
Study officials:
References: