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NCT Number: NCT04077203

Biofeedback of Glucose in Non-diabetic Participants

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.

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Key information

Conditions

Blood Glucose Biofeedback

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klick Inc.

Toronto, Ontario, M4W 3R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback / No biofeedback

Behavioral

Biofeedback / No biofeedback

Primary outcomes

  1. Weight in kg

    Time frame: 2 weeks

    Weight in kg

  2. Body Mass Index (BMI)

    Time frame: 2 weeks

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

  3. Body fat %

    Time frame: 2 weeks

    Using a smart scale

  4. Resting heart rate

    Time frame: 2 weeks

    Using a sphygmomanometer with heart rate sensor

  5. Resting blood pressure (systolic and diastolic)

    Time frame: 2 weeks

    Using a sphygmomanometer

  6. Self-reported positive and negative affect

    Time frame: 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.

  7. Self-reported general health

    Time frame: 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.

  8. Self-reported perceived stress

    Time frame: 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.

  9. Self-reported sleep quality

    Time frame: 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.

  10. Self-reported general well-being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Klick Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2019
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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