A Clinical Study to Evaluate the Safety of the GlySure Continuous Intra-vascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Safety in Use
研究概览
简要总结
It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose monitoring system in patients in a surgical ICU environment after cardiac surgery. This study seeks to evaluate the same equipment being used in a wider range of patients with a range of underlying conditions who require treatment in medical ICU's. The GlySure device consists of a sensor that is placed into the patient's blood through a central venous catheter. It measures blood glucose levels continuously which allows for more rapid control of blood glucose levels to be achieved as compared to existing methods where blood samples are taken repeatedly every 15 minutes or so.
The study is designed to show that the sensor can be used for a protracted period of time, giving accurate results when compared to a reference technique using the i-STAT device. The investigators intend to show that the device performs safely for the required time within the ICU.
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
- 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
- •Patient is male or female aged 18 years or above
- •Patient requires a CVC to be inserted as part of disease management and treatment
- •Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study
排除标准
- •Patient or legal representative is unable to provide written informed consent
- •Patient who is pregnant
- •Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
- •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 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 or StatLock® devices
结局指标
主要结局
Safety in Use
时间窗: During ICU Stay, normally less than 7 days
No Serious Adverse Events causally related to the device
MARD Score
时间窗: During ICU stay, normally less than 7 days
Average aggregate MARD to be below 10%, 95% of subjects to have a MARD of less than 25%
次要结局
未报告次要终点