Database and Calibration 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
- 12
- 试验地点
- 1
- 主要终点
- Generation and validation of predictive algorithms for determining blood glucose levels
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 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 (all types) patients
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
- •Rejection by prescreening optical measurements
- •Known allergy to medical grade alcohol used to disinfect skin
研究组 & 干预措施
Short term collection of IMD data
Subjects will collect spectral raman data on WM3.4NR four times a day for 30 days distributed over a time period of 60 days. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.
干预措施: WM3.4NR (Device)
Long term collection of IMD data
Subjects will collect spectral raman data on WM3.4NR four times a day for the initial 30 days, distributed over a time period of 60 days. Subjects will for the remaining 60 days of measurements, distributed over 120 days collect spectral data twice a day. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.
干预措施: WM3.4NR (Device)
结局指标
主要结局
Generation and validation of predictive algorithms for determining blood glucose levels
时间窗: 7 months
Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid
次要结局
未报告次要终点