Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 11
- 主要终点
- Measurement accuracy
研究概览
简要总结
This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
详细描述
Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.
The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.
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
- •Male and female subjects ≥18 years of age
- •Diagnosed with diabetes, all types except gestational diabetes
- •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 the local language
- •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)
- •Subject diagnosed with cardiovascular diseases
- •Reduced circulation in right hand evaluated by Allen's test
- •Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
- •Radiotherapy for the past six months
- •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
时间窗: 6 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).
Safety evaluation: paucity of adverse events
时间窗: 6 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 usability(6 months)
- Device deficiencies(Up to 6 months)