A Pilot Trial to Evaluate the Precision and Accuracy of the Non-invasive H.G.R Glucometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- difference between core lab and non invasive glucose measurements
研究概览
简要总结
A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes.
The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female.
- •Age above or equal to 18 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- •HbA1c of 6.0-8.0% .
排除标准
- •Participants under the age of 18 years
- •pregnant women or patients with normal blood glucose.
研究组 & 干预措施
Non invasive glucose monitor
Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab
干预措施: H.G.R (GWave) non-invasive glucometer (Device)
结局指标
主要结局
difference between core lab and non invasive glucose measurements
时间窗: 3 HOURS
difference between core lab and non invasive glucose measurements
次要结局
未报告次要终点
研究者
Prof. Amir Tirosh
Director, Division of Endocrinology
Sheba Medical Center