A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 12
- 主要终点
- Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
研究概览
简要总结
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.
详细描述
This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year.
Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- •Adequate venous access as assessed by investigator or appropriate staff
- •Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.
排除标准
- •Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual
- •Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
- •Subject is actively participating in 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 the investigator
- •Subject is female and plans to become pregnant during the course of the study
- •Subject has had a hypoglycemic seizure within the past 6 months
- •Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- •Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
- •Subject has a history of a seizure disorder
- •Subject has central nervous system or cardiac disorder resulting in syncope
- •Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- •Subject has a hematocrit (Hct) lower than the normal reference range
- •Subject has a history of adrenal insufficiency
结局指标
主要结局
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
时间窗: 7 Days
Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.
次要结局
- Retrospective Re-Analysis (MARD With 1 Additional Calibration)(7 Days)
- Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)(7 Days)