NCT02649010撤回不适用
A Performance Evaluation of the Enlite 3 Sensor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Enlite 3 Sensor inserted at Arm accuracy using a real time device: (640G pump) with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated.
研究概览
简要总结
The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor performance in arm in subjects age 14 - 75 years.
详细描述
The study is a multi-center, randomized, prospective single-sample correlational design without controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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.
- •A clinical diagnosis of type 1 or 2 diabetes for a minimum of 9 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 Enlite 3 Sensors 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 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 inserted at Arm accuracy using a real time device: (640G pump) with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated.
时间窗: 1 month
Glucose sensor values will be compared to Yellow Spring Instruments (YSI)plasma glucose values during Frequent Sample Testing.
次要结局
未报告次要终点
研究者
研究点 (4)
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