Blood GlucoseNCT04077203
Biofeedback of Glucose in Non-diabetic Participants
A study testing Biofeedback / No biofeedback in people with Blood Glucose and Biofeedback, run by Klick Inc. at 1 site in Canada.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Biofeedback
- What is being tested?
- Biofeedback / No biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Blood Glucose, Biofeedback
- Being tested
- Biofeedback / No biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback / No biofeedbackBehavioural
Biofeedback / No biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Those receiving no visual feedback because the handheld device monitor will be occluded with black tape (the control group). Receives: Behavioral: Biofeedback / No biofeedback |
| Test | Experimental | Those receiving the ability to visualize their glucose levels via the handheld device (the biofeedback group). Receives: Behavioral: Biofeedback / No biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in kg
Weight in kg
Measured: 2 weeks
Body Mass Index (BMI)
Height in cm and weight in kg will be used to calculate BMI
Measured: 2 weeks
Body fat %
Using a smart scale
Measured: 2 weeks
Resting heart rate
Using a sphygmomanometer with heart rate sensor
Measured: 2 weeks
Resting blood pressure (systolic and diastolic)
Using a sphygmomanometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start16 Jul 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klick Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077203
- Sponsor's protocol ID
- Pro00036792
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback of Glucose in Non-diabetic Participants
- ClinicalTrials.gov ID
- NCT04077203
- Acronym / sponsor ID
- Pro00036792
- Conditions
- Blood Glucose, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Klick Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Behavioral: Biofeedback / No biofeedbackThose receiving no visual feedback because the handheld device monitor will be occluded with black tape (the control group). |
| Test | Experimental | Behavioral: Biofeedback / No biofeedbackThose receiving the ability to visualize their glucose levels via the handheld device (the biofeedback group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback / No biofeedbackBiofeedback / No biofeedback | Behavioural | Control, Test |
Primary outcome
Weight in kg
Time frame: 2 weeks
Weight in kg
Body Mass Index (BMI)
Time frame: 2 weeks
Height in cm and weight in kg will be used to calculate BMI
Body fat %
Time frame: 2 weeks
Using a smart scale
Resting heart rate
Time frame: 2 weeks
Using a sphygmomanometer with heart rate sensor
Resting blood pressure (systolic and diastolic)
Time frame: 2 weeks
Using a sphygmomanometer
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback / No biofeedback in people with Blood Glucose and Biofeedback, run by Klick Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight in kg (time frame: 2 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.