NCT01942902已完成不适用
A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring Using the Yellow Springs Blood Glucose Analyser for Conformité Européenne (CE) Marking Purposes in a Total of Thirty Patients Admitted to The Surgical Intensive Care Unit (SICU)
GlySure4 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results
研究概览
简要总结
The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legal representative MUST be willing to sign an informed consent document
- •Male and female aged 18 years and above
- •Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment
- •Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-
排除标准
- •Patient or legal representative unable to provide written informed consent
- •Patient who is pregnant
- •Patient who is currently being administered Mannitol
- •Patient with history of Pulmonary Embolism (PE)
- •Patient with history of thrombosis
- •Patient with known hyper-coagulation
- •Patient with known history of heparin hypersensitivity
- •Patient with history of heparin induced thrombocytopenia
- •Participation in a clinical study involving an unlicensed pharmaceutical product and/or device within the 3 months prior to enrolment in this study
- •Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film
- •Patient likely to require an MRI scan during their stay in the SICU
- •Patients likely to require treatment with Mannitol during time in the SICU
结局指标
主要结局
Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results
时间窗: For at least 30 hours and up to 7 days
The study is designed to evaluate the comparative accuracy between measured blood glucose results obtained from the GlySure Continuous Glucose Monitoring System (CGM) and the YSI, and to determine if any condition or treatment affects the sensor's measured values.
Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices
时间窗: For at least 30 hours and up to 7 days
次要结局
未报告次要终点
研究者
研究点 (4)
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