NCT03602963已完成不适用
A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System
Jessa Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年7月9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
- 10
- 试验地点
- 1
- 主要终点
- Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations
研究概览
简要总结
- The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2 weeks the patients will do at least four capillary blood glucose measurements to compare with the sensor results.
- Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month.
- The data recorded by the FreeStyle Libre Flash glucose monitoring system (average glucose,% above target, % within target, % under target, amount of hypoglycemia) in the month prior to the 2 weeks of double sensor wear will be compared to the same data recorded by the Dexcom G5 mobile CGM system during the first month of use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus
- •Treated by insulin injections
排除标准
- •Other types of diabetes
- •Treated with insulin pump
结局指标
主要结局
Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations
时间窗: 2 weeks
Comparison of sensor glucose measurements will be compared with capillary blood glucose measurements at least 4 times a day
次要结局
- Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire(1 month)
研究者
研究点 (1)
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