Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Clarke Error Grid
研究概览
简要总结
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.
The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.
The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes
详细描述
See Brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1or 2 Diabetes
- •Anatomically suitable earlobe
排除标准
- •Subjects requiring dialysis
- •Any conditions that may hamper good contact between the PEC and the earlobe
- •Pregnancy
- •Nursing mothers
研究组 & 干预措施
Experimental
subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.
干预措施: GlucoTrack (Device)
结局指标
主要结局
Clarke Error Grid
时间窗: one year
次要结局
- User Satisfaction(one year)