Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense Sensor as a Tool for Detection of Hypoglycemia - Exploratory Study for Prototype Rev 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device.
The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods
The proposed study will be consisting of two main segments:
The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer.
The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events.
During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events.
During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 prior to any trial related procedure
- •Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- •Age > 18 years old
排除标准
- •Participating in other device or drug study
- •Any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study
- •Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- •Chronic skin problem in the lower inner arm
- •Pregnant or breast feeding women
研究组 & 干预措施
Hypo-Sense (non invasive sensor)
Parallel measurements of capillary blood glucose using reference method and data generated by the non- invasive study device (Hypo Sense) during approximately 4 hours, in which a hypoglycemic event will be induced.
干预措施: Hypo-Sense (non invasive sensor) (Device)
结局指标
主要结局
Sensitivity
时间窗: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer
Positive Predictive Value of the hypo-Sense
时间窗: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
Positive Predictive Value of the hypo sense- the proportion of validated ("true") hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor
次要结局
未报告次要终点