Non-invasive Measurement of Blood Glucose, Blood Pressure and Extrapolation of QRS Complex Using a Wrist Wearable Photoplethysmography Sensor
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The purpose of this research is to compare blood glucose, blood pressure and electrocardiogram (ECG) readings on the LIFELEAF Smartwatch compared to standard methods of measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care.
- •Patients undergoing continuous monitoring for heart rate, ECG and blood pressure as part of their routine care.
- •Patients undergoing invasive and noninvasive electrophysiologic procedures.
排除标准
- •Patients unable to provide informed consent.
- •Patients without arms as these are needed to wear the wrist-based sensor.
结局指标
主要结局
Systolic Blood Pressure
时间窗: Baseline
Difference in measurement of Systolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).
Diastolic Blood Pressure
时间窗: Baseline
Difference in measurement of Diastolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).
Blood Glucose Level
时间窗: Baseline
The difference in measurement of blood glucose levels using the wrist-based PPG sensor versus standard blood-based measurement measured in milligrams per deciliter (mg/dL) in subjects who had standard of care blood glucose monitoring done. Only subjects who are hospitalized and diabetic per standard of care receive standard of care blood-based glucose monitoring.
次要结局
未报告次要终点
研究者
Narayan (Guru) G. Kowlgi
Principal Investigator
Mayo Clinic