Biofeedback of Glucose in Non-diabetic Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Klick Inc.
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Body fat %
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Body fat %
时间窗: 2 weeks
Using a smart scale
Resting blood pressure (systolic and diastolic)
时间窗: 2 weeks
Using a sphygmomanometer
Self-reported sleep quality
时间窗: 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
时间窗: 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
时间窗: 2 weeks
Weight in kg
Self-reported positive and negative affect
时间窗: 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)
时间窗: 2 weeks
Height in cm and weight in kg will be used to calculate BMI
Self-reported perceived stress
时间窗: 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
时间窗: 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
时间窗: 2 weeks
Using a sphygmomanometer with heart rate sensor
次要结局
未报告次要终点