Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Safety Evaluation
研究概览
简要总结
This study is a prospective, single center, non-interventional, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE system compared to the standard glucometer in the determination of blood glucose level in adult patients.
详细描述
The current methods for blood glucose measurements, glucometers, although minimally invasive, can be painful, requiring puncturing the fingertip with a lancet device and removing a drop of blood, that applies to a disposable test strip. This minimal invasiveness may cause discomfort and deter the user from measuring his/her blood glucose levels as frequently as required. Due to GLUCUBE device non-invasive nature, it is expected to give the patient or health care provider immediate reliable quantitative as well as qualitative information, safely and painlessly avoiding any type of discomfort to the user.
This study is a prospective, single center, non-interventional, open label clinical investigation designed with a total amount of 105 subjects. Study participants will take the GLUCUBE device and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Be ≥ 18 years old.
- •Have a smartphone with an internet connection that allows the installation of GLUCUBE APP
- •Have signed the informed consent.
排除标准
- •Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study.
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- •Patients with any acute active and/or infectious disease.
- •Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
- •Any medical condition that, by the investigator judgment, will increase the risk from hyper and hypoglycemic event: seizures, heart disease, hypoglycemia unawareness, etc.
- •Patients who, in the opinion of the investigator, do not have sufficient manual dexterity to perform the tests themselves.
- •Patients with an inability to maintain stability of the hand during measurement or with progressive disease of the nervous system that affects movement (Parkinson's disease, moderate-severe essential tremor, and other diseases with involuntary movements).
- •Patients suffering from calluses, malformations, or open wounds with bandages.
- •Patients with nail polish or any type of false nail.
- •Subjects who do not understand or cannot follow the Procedures Involved in the Use of the Device Under Investigation.
结局指标
主要结局
Safety Evaluation
时间窗: All AE will be collected during participation in the study since V1 at V2 (8 days)
All (Serious) Adverse Events and GLUCUBE device related adverse events: local and systemic effects of GLUCUBE device, and the standard glucometer, including, but not limited to redness, burns, pain, or other complications such as bleeding or local infection will be collected.
Performance Evaluation
时间窗: 4 times/day for 1 week
GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next). Each pair of measurements includes one measurement with the standard glucometer (Bayer Contour®Next) and one measurement with GLUCUBE device.
次要结局
- Performance Evaluation(through study completion, an average of 8 days)