NCT03249974已完成不适用
A Comparative Study on the Accuracy, Ease of Use and Skin Reactions Between the Enlite Sensor With Guardian 2 Link Transmitter and the FreeStyle Libre Flash Glucose Sensor
Jessa Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Accuracy of Enlite sensor
研究概览
简要总结
- The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.
- Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month.
- The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.
- The data recorded by the FreeStyle sensor (average glucose,% above target,% within target,% under target, amount of hypoglycemia) in the month prior to sensor switching will be compared to the same data recorded by the Enlite sensor during the first month of use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (5 to 18 years)
- •Diagnosis of type 1 diabetes mellitus
- •Treatment is an insulin pump and wearing a FreeStyle Flash Libre glucosesensor
排除标准
- 未提供
结局指标
主要结局
Accuracy of Enlite sensor
时间窗: 2 hours
The accuracy of the sensors (flash vs enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.
次要结局
- Usability of Enlite sensor(1 month)
- skin reactions wih Enlite sensor(1 month)
研究者
研究点 (1)
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