NCT02696252已完成不适用
Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL
研究概览
简要总结
Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
详细描述
The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 2 or older
- •Diagnosis of Type 1 diabetes or Type 2 diabetes
- •Willing to participate in a clinic session involving venous sampling for evaluation of study end point
排除标准
- •Use of acetaminophen
- •Known allergy to medical-grade adhesives
- •Pregnancy
- •Hematocrit outside specification of the study-assigned blood glucose meter
结局指标
主要结局
proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (4)
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