An Explorative Study of a Novel Non-invasive Glucose Measuring Device in Out-patient Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Safety evaluation of the Investigational Medical Device by reporting of adverse events
研究概览
简要总结
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 minimum 18 years of age
- •Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
- •Willing to perform up to 12 finger-pricks during each day of out-patient measurements
- •Signed informed consent
- •For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
- •Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study
排除标准
- •For female subjects: Pregnancy or breastfeeding
- •Skin phototype VI categorized by Fitzpatrick scale measured on thenar
- •Subjects not able to understand and read local language
- •Cognitive impairment, or 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)
- •Extensive skin changes, tattoos or diseases on right thenar (measurement site)
- •Reduced circulation in right hand evaluated by Allen's test
- •Known allergy to medical grade alcohol
- •Hemodialysis
- •Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
- •Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
- •Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
- •Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
- •Subjects currently participating in another study
- •Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-
- •Incapacity for consent
结局指标
主要结局
Safety evaluation of the Investigational Medical Device by reporting of adverse events
时间窗: 2 years
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation
Determination of number of calibration days
时间窗: 2 years
The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid.
次要结局
- Device function(2 years)