A Pilot Study of a Novel 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
- 1
- 主要终点
- Measurement accuracy of IMD
研究概览
简要总结
This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
详细描述
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.
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
- •Diagnosed with diabetes, all types except gestational diabetes
- •HbA1c distribution > 60 mmol/mol at baseline visit
- •Skin phototype 1-4
- •Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
- •Subject has a wireless internet connection at home to be used in the study
排除标准
- •For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- •For female subjects: Breastfeeding
- •Subject currently participating in another study
- •Subject not able to understand and read Danish
- •In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
- •Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
- •Reduced circulation in right hand evaluated by Allen's test
- •Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
- •Known allergy to medical grade alcohol used to clean the skin
- •Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
- •Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff
结局指标
主要结局
Measurement accuracy of IMD
时间窗: 4 months
Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)
Safety evaluation: paucity of adverse events
时间窗: 4 months
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study
次要结局
- Device deficiency(4 months)
- Device usability(4 months)