Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
研究概览
简要总结
The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.
详细描述
The non invasive continuous glucose sensing system of Physical Logic is based on a vector network analyzer (VNA), which monitor blood glucose through propriety sensors.Dielectric spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by the electric dipole moment of the sample it interacts with. This method utilizes the change in the impedance of the antenna to measure the change in the relaxation processes of the interrogated medium.
The VNA (vector network analyzer) , which emits non irradiating electromagnetic waves in very low power emission, is connected via standard coaxial cables to propriety sensors that are attached to the patient skin without direct contact.
Study objective:
To evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.The glucose values generated by the investigational non invasive devise will be compared to glucose reading of a reference devise, which measure blood glucose levels at the subcutaneous tissue.
During the study we will evaluate the reliability of the study device under the conditions of alter blood glucose values in the range of 50-400 mg/dl:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing an inform consent form
- •Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- •Age > 18 years old
- •Willing to perform all study related procedures
排除标准
- •Known or suspected allergy to the sensor or one of its components
- •Psychiatric disorder
- •Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- •Patients who are not willing or are not capable of performing the protocol requirements
- •Participating in another study that includes investigational drug or investigational equipment
结局指标
主要结局
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
时间窗: up to 24 weeks
Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels
次要结局
未报告次要终点