Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Generation and validation of predictive calibration models
研究概览
简要总结
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
详细描述
Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Male and female subjects 18 years of age or older
- •Diabetic patients (all types)
排除标准
- •Pregnant women
- •Subjects not able to understand and read Danish
- •In investigator's opinion, subject is not able to follow instructions as specified in the protocol
- •Subjects not able to hold hand/arm steadily
- •Extensive skin changes, tattoos or diseases on probe application site
- •Known allergy to medical grade alcohol used to disinfect skin
研究组 & 干预措施
IMD data collection
Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators.
干预措施: WM3.4NR (Device)
结局指标
主要结局
Generation and validation of predictive calibration models
时间窗: 3 months
The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.
次要结局
- Safety assessment of the intervention by the paucity of adverse events(3 months)