A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- 24 hour calibration requirement
研究概览
简要总结
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.
详细描述
The study is a multi-center, 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
- Device Feasibility
- 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 6 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
排除标准
- •Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual.
- •Subject has any unresolved adverse skin condition in the area of Harmony 1 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 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.
研究组 & 干预措施
Harmony 1 Sensor Group A
Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 90 minutes after sensor insertion.
干预措施: Harmony 1 Sensor (Device)
Harmony 1 Sensor Group B
Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 12 hours after sensor insertion.
干预措施: Harmony 1 Sensor (Device)
结局指标
主要结局
24 hour calibration requirement
时间窗: 10 days
Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements
次要结局
未报告次要终点