Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Interference Effect for the G6 CGM
研究概览
简要总结
The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.
详细描述
The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.
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
The system will be blinded to the user, i.e. no glucose values will be displayed to the subject during the study duration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 or older
- •Diagnosis of diabetes
排除标准
- •Pregnancy
- •Known gastroparesis
- •Abnormal liver function
研究组 & 干预措施
CGM Users
Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.
干预措施: Acetaminophen Challenge (G6 CGM) (Device)
结局指标
主要结局
Interference Effect for the G6 CGM
时间窗: 6 hrs post dose
Bias of sensor to reference measurement pre and post acetaminophen administration
次要结局
- Mean of sensor minus YSI values (bias) for various time periods(6 hrs post dose)
- Duration of interference effect for the G6 CGM(6 hrs post dose)