A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
研究概览
简要总结
The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
详细描述
This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study.
Each subject will wear the following devices:
• Two Enlite Sensors each connected to an iPro2 for approximately 6 days
Sensor Location:
• The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 14 - 75 years of age at time of screening
- •Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- •Subject has adequate venous access as assessed by investigator or appropriate staff
- •Subject is willing to follow the study procedures and willing to come to study visits.
- •Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days
排除标准
- •Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
- •Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- •Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- •Subject is female and has a positive pregnancy screening test
- •Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
- •Subject is female and plans to become pregnant during the course of the study
- •Subject has a hematocrit (Hct) lower than the normal reference range
- •Subject may not be on the research staff of those performing this study
研究组 & 干预措施
Study arm
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).
干预措施: Enlite 1 connected to iPro2 recorder (Device)
结局指标
主要结局
Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
时间窗: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI \<= 80 mg/dL) during YSI frequent sampling testing (FST) days.
次要结局
- Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)(YSI FST days (Day 1, 3-4, or 6 of sensor wear))
- Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values(YSI FST days (Day 1, 3-4, or 6 of sensor wear))
- Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values(YSI FST days (Day 1, 3-4, or 6 of sensor wear))