Biofeedback of Glucose in Non-diabetic Participants

Not Applicable

Completed

• Conditions: Blood Glucose; Biofeedback
• Interventions: Behavioral: Biofeedback / No biofeedback

• Registration Number: NCT04077203
• Lead Sponsor: Klick Inc.

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.

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-30
• Status Verified: 2019-09
• Study First Posted: 2019-09-04
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Last Update Submitted: 2020-11-14
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Biofeedback / No biofeedback	Those receiving the ability to visualize their glucose levels via the handheld device (the biofeedback group).
Control	Biofeedback / No biofeedback	Those receiving no visual feedback because the handheld device monitor will be occluded with black tape (the control group).

Primary Outcome Measures

Name	Time	Method
Body fat %	2 weeks	Using a smart scale
Resting blood pressure (systolic and diastolic)	2 weeks	Using a sphygmomanometer
Self-reported sleep quality	2 weeks	Pittsburgh Sleep Quality Index (Buysse et al., 1989). This is a 19-item scale that measures self-reported sleep quality and sleep disturbances, comprised of open-ended questions and scaled items evaluated on a 4-point Likert scale. The range of possible total scores is 0 to 21, with higher scores indicating poorer sleep quality.
Self-reported general health	2 weeks	12-Item Short-Form Health Survey (SF-12; Ware et al., 1996). The scale measures overall general self-reported physical and mental health using 12 items, on 2 to 6-point ordinal scales. The range of possible total scores is 12 to 48, with higher scores indicating better health.
Weight in kg	2 weeks	Weight in kg
Self-reported positive and negative affect	2 weeks	Positive and Negative Affect Schedule (PANAS; Watson et al., 1988). The scale consists of 20 items (10 for Positive Affect; 10 for Negative Affect), with each item rated on a 5-point scale of 1 (not at all) to 5 (extremely). Items are summed for Positive affect and Negative affect, with higher scores indicating a higher level of affect in each respective scale.
Body Mass Index (BMI)	2 weeks	Height in cm and weight in kg will be used to calculate BMI
Self-reported perceived stress	2 weeks	Perceived Stress Scale (Cohen et al., 1983; Cohen \& Williamson, 1988). This is a 4-item scale that measures overall stress with each item evaluated on a 5-point Likert scale. The range of possible total scores is 0 to 16, with higher scores indicating more stress.
Self-reported general well-being	2 weeks	Satisfaction with Life Scale (Diener et al., 1985). This is a 5-item scale that measures overall well-being with each item evaluated on a 7-point Likert scale. The range of possible total scores is 5 to 35, with higher scores indicating higher well-being.
Resting heart rate	2 weeks	Using a sphygmomanometer with heart rate sensor

Trial Locations

Locations (1)

Klick Inc.; 🇨🇦 Toronto, Ontario, Canada