Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.
研究概览
简要总结
To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.
详细描述
A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 years or older
- •Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)
- •Willing to participate in a clinic session
排除标准
- •Use of Acetaminophen during study period
- •Pregnancy
- •Hematocrit (HCT) <35% (females) and 38% (males)
- •Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.
- •Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.
研究组 & 干预措施
Continuous Glucose Monitoring System
Single-Arm, CGM Device Glucose challenge performed during a clinic session to obtain accuracy data for the CGM system compared to a venous reference measurement
干预措施: Continuous Glucose Monitoring (Device)
结局指标
主要结局
The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.
时间窗: 7-day wear period
The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels \> 80 mg/dL or within 20 mg/dL at the reference glucose levels \< 80 mg/dL.
次要结局
未报告次要终点