Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device.
研究概览
简要总结
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated Subcutaneous Blood Glucose Monitor (SBGM) which is a source of severe inconvenience and hence, a lack of compliance.
Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.
The Glucometer CGM-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.
The primary objectives of the trial are to determine:
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels
- The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device.
时间窗: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay
时间窗: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value
时间窗: will be assessed after second experimental day
次要结局
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels(The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours.)