Biofeedback of Glucose in Non-diabetic Participants

Klick Inc.

Status: Completed

Conditions: Blood Glucose; Biofeedback

Treatments: Behavioral: Biofeedback / No biofeedback

Study type: Interventional

Funder types: Industry

Identifiers

NCT04077203

Pro00036792

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

Sham Comparator group

Description:

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

Treatment:

Behavioral: Biofeedback / No biofeedback

Test

Experimental group

Description:

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

Treatment:

Behavioral: Biofeedback / No biofeedback