Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 482
- 试验地点
- 12
- 主要终点
- Dexcom Continuous Glucose Monitoring System Performance
研究概览
简要总结
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
详细描述
The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.
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
盲法说明
All systems worn will be blinded. Sensor wear locations will be pre-assigned. All sensor insertions will be performed at the clinic by subjects and/or caregivers.
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 wear the required number of Systems for the total duration of study wear
- •Willing to participate in Clinic Session(s) during study wear
排除标准
- •Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- •Known allergy to medical-grade adhesives
- •Pregnancy
- •Hematocrit outside specification
- •≥ 18 years of age:
- •Male: 36.0%;
- •Female: 33.0%;
- •13-17 years of age: 35.0%;
- •7 years - 12 years of age: 32.0%;
- •End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
- •Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
研究组 & 干预措施
CGM Users
Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.
干预措施: Dexcom Continuous Glucose Monitoring System (Device)
结局指标
主要结局
Dexcom Continuous Glucose Monitoring System Performance
时间窗: 10 days
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements
次要结局
- System Related Adverse Device Effects(10 days)