Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors
研究概览
简要总结
This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated.
详细描述
The Dexcom G7 will be placed either by an anesthesiologist or nurse anesthetist, or critical care physician, nurse or nurse manager upon arrival to CVICU, post cardiac surgery.
Standard of care:
Accuchek will be done per standard of care for post operative patients that are in 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
- Other
- 盲法
- None
盲法说明
The study will involve using blinded Dexcom G7 continuous glucose monitoring (CGM) devices
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
- •Age 18 years old and above
- •Planned cardiothoracic surgery
- •Planned admission to Cleveland Clinic Main Campus building J5 or J6 or Q5 cardiovascular intensive care unit (CVICU) followed by transfer to the step down unit
- •With or without known diabetes (as 75% of patients entering the CVICU have hyperglycemia requiring intravenous insulin infusion)
- •If with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary (such as due to glucocorticoids or pancreatitis
排除标准
- •Allergy to the material of the continuous glucose monitoring systems (CGMS) or the adhesive to be used
- •Skin conditions precluding the use of the CGMS
- •Pregnancy
- •Other conditions that the investigators deem inappropriate for the study
- •Patients receiving mechanical circulatory assist devices
研究组 & 干预措施
Single Arm
All patients will receive the Dexcom G7 continuous glucose monitor (CGM)
干预措施: Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode (Device)
结局指标
主要结局
Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors
时间窗: 1 - 10 days
Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors
Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU
时间窗: 1 - 10 days
Compare accuracy of glucose readings obtained from Dexcom G7 Compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick POC while patients are in the CVICU
次要结局
未报告次要终点