NCT02345967已完成不适用
Function of Implanted Glucose Sensor 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
- •Diabetes diagnosis of type 1, or type 2 using insulin
- •Under the routine care of a physician for diabetes treatment
- •Able to understand and follow directions
- •History of compliance with diabetes care regimen
- •Able to comply with study requirements regarding planned clinical visits and exams
- •In good physical condition without major medical concerns or blood chemistry abnormalities
排除标准
- •Mental disorders that might affect compliance to protocols
- •Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
- •History of intolerance or sensitivity to any of the device materials
- •History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
- •History of recurrent skin infections
结局指标
主要结局
Number of Adverse Events
时间窗: From enrollment to 2-weeks post-explant
Incidence of adverse events related to the Intervention
次要结局
未报告次要终点
研究者
研究点 (4)
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