Biofeedback of Glucose in Non-diabetic Participants

NCT04077203 | Completed

• 1 other identifier: Pro00036792
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose; Biofeedback

Outcome Measures

Primary Outcomes (10)

• Weight in kg

  Weight in kg

  2 weeks

• Body Mass Index (BMI)

  Height in cm and weight in kg will be used to calculate BMI

  2 weeks

• Body fat %

  Using a smart scale

  2 weeks

• Resting heart rate

  Using a sphygmomanometer with heart rate sensor

  2 weeks

• Resting blood pressure (systolic and diastolic)

  Using a sphygmomanometer

  2 weeks

• Self-reported positive and negative affect

  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.

  2 weeks

• Self-reported general health

  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.

  2 weeks

• Self-reported perceived stress

  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.

  2 weeks

• Self-reported sleep quality

  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.

  2 weeks

• Self-reported general well-being

  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.

  2 weeks

Study Arms (2)

Control

SHAM COMPARATOR

Those receiving no visual feedback because the handheld device monitor will be occluded with black tape (the control group).

Behavioral: Biofeedback / No biofeedback

Test

EXPERIMENTAL

Those receiving the ability to visualize their glucose levels via the handheld device (the biofeedback group).

Behavioral: Biofeedback / No biofeedback

Interventions

Biofeedback / No biofeedback BEHAVIORAL

Biofeedback / No biofeedback

Control; Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Klick Inc.: lead

Study Sites (1)

Klick Inc.

Toronto, Ontario, M4W 3R8, Canada

Location

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 4, 2019
• Study Start: July 16, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: November 17, 2020

Record last verified: 2019-09

Locations

CA (1)