A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites
研究概览
简要总结
The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.
详细描述
The study is a multi-center, prospective single-sample correlational design without controls. Between 4 and 10 investigational sites will be used during this study. All subjects will be assigned to treatment. Each subject will wear the following devices:
- Enlite Sensors (2) connected to MiniLinks (2)
- Revel 2.0 Pumps (2)
During the study each subject will be wearing 2 sensors and 2 pumps simultaneously. The pumps will be differentiated by color, and will have different calibration requirements during the in-clinic portions of the study. During the Frequent Sampling Tests:
- GREEN pump will be calibrated 3-4 times spread throughout the day
- RED pump will have the minimum calibration requirements (every 12 hours after the second calibration)
During home use (outside the clinic) BOTH pumps will be calibrated 3-4 times spread throughout the day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 - 75 years of age at time of screening
- •A clinical diagnosis of type 1 or 2 diabetes as determined by the
- •Investigator, for a minimum of 12 months duration:
- •Criteria for type 1 diabetes:
- •Required: Age of onset < 40 years of age
- •Required: History of insulin use only for management of diabetes
- •Required: history of normal weight or underweight at time of diagnosis.
- •Not required: Initial presentation of diabetic ketoacidosis.
- •Not required: History of diabetic ketoacidosis
- •Not required: Low fasting C-peptide
- •Criteria for type 2 diabetes:
- •Required: Age of onset ~ 40 years of age
- •Required: History of initial oral anti-diabetic use
- •Required: History of being overweight at time of diagnosis.
- •Type 2 insulin requiring is defined by type 2 diabetes subjects taking insulin with or without oral anti-diabetic agent and may also include: incretin mimetic, pramlintide or GLP agonist
- •Type 2 non-insulin requiring is defined by type 2 diabetes subjects who take oral medications and may also include: incretin mimetic, pramlintide or GLP agonist
- •Adequate venous access as assessed by investigator or appropriate staff
排除标准
- •Subject is unable to tolerate tape adhesive in the area of sensor placement.
- •Subject has any unresolved adverse skin condition in the area of sensor 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 has a positive pregnancy screening test
- •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 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
- •Subjects with hematocrit lower than 36%
- •SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias
- •Subjects with a history of adrenal insufficiency
- •Subjects with migraines
研究组 & 干预措施
Enlite sensor, Abdomen/Abdomen
Subjects wearing 2 Enlite sensors in Abdomen
干预措施: Enlite Sensor (Device)
Enlite sensor, Abdomen/Buttock
Subjects wearing 2 Enlite sensors in Abdomen/Buttock
干预措施: Enlite Sensor (Device)
Enlite sensor, Buttock/Buttock
Subjects wearing 2 Enlite sensors in Buttock/Buttock
干预措施: Enlite Sensor (Device)
结局指标
主要结局
Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites
时间窗: Days 1, 3 and 6 of sensor wear
Primary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI \<75 mg/dL) with the minimum calibration (every 12 hour), combined abdomen and buttock insertion sites across all participants and all days.
次要结局
- Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion(Days 1, 3 and 6 of sensor wear)