Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 304
- 试验地点
- 9
- 主要终点
- Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL
研究概览
简要总结
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System
详细描述
The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.
The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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, on intensive insulin therapy
- •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
研究组 & 干预措施
CGM Users
Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement
干预措施: CGM (Device)
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 proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL
时间窗: 10 Days
次要结局
未报告次要终点