Continuous Glucose Monitoring During and After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues
研究概览
简要总结
During surgery and after surgery elevated blood glucose levels can lead to poor outcome such as wound infections. Current technology does not allow close monitoring of glucose levels often resulting in poor management of glucose levels. In this study, the investigators will evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 6 Professional) during and after surgery. Such a monitor has the potential of monitoring glucose levels continuously and in real-time, thus allowing better glucose management
详细描述
During surgery high blood glucose levels, termed hyperglycemia, are commonly encountered due to the physiological stress. Hyperglycemia has been associated with complications such as surgical site infections, adverse cardiovascular and pulmonary events. Optimal glucose control targeted at preventing hyperglycemia has been shown to reduce the risk of complications. However, performing optimal glycemic management during and after surgery is a significant challenge because varying effects of surgical stress and anesthesia interventions produce rapid changes in glucose levels. The current method of manually measuring blood glucose every hour or less is grossly inadequate to track changes in glucose levels. Continuous Glucose Monitors (CGMs) have the ability to automatically measure blood glucose levels in near continuous fashion. Integrating CGMs as part of a glycemic control protocol can lead to better management of glucose levels with fewer hyperglycemia episodes and lower glucose level variability resulting in better post-surgical outcome. The viability of using a CGM in during and after surgery has only been minimally studied, that too with older generation systems. The investigators propose a study that aims to evaluate viability of using a current generation CGM in surgery patients.
The primary goal of this study is to evaluate the feasibility and accuracy of a Continuous Glucose Monitor (CGM) in measuring blood glucose levels and trends in surgery patients. The secondary goal is to observe and analyze trends in perioperative blood glucose levels to understand the dynamic effects of surgical stress and anesthetic agents on blood glucose levels. This information will allow development of better intraoperative glucose management strategies and protocols. The specific aims of the study are outlined below:
- Compare glucose measurements made by a next generation, investigational Continuous Glucose Monitor (Dexcom Gen 6 Professional CGM) against point of care (POC) glucose meter (Accu Chek Inform II, Roche Diagnostics), during the intraoperative and postoperative periods.
- Correlate the trends in glucose levels measured by a CGM against surgery and anesthesia events (Induction, Incision, Emergence) and factors, and administration of anesthetic drugs (inhalational agents, steroids, etc)
The study protocol is described below:
CGM:
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥ 18 years) diabetic (both Type 1 & 2) patients who are self-monitoring glucose levels (via finger stick measurements) two to three times daily.
- •Scheduled to have elective general surgery at UW Medical Center. Preferably target Surgery A- Orthopedic/GYN surgery/Bariatric patients.
- •Proposed case duration > 2 hour case.
排除标准
- •Pregnant and lactating females
- •MRI, CT & Diathermy procedure
结局指标
主要结局
Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues
时间窗: After 4 patients (2 months)
After CGM has been applied on the first 4 patients, the study team will evaluate the safety and feasibility of using CGM. Specifically, the team will check whether there are unanticipated adverse events such as rashes or discomfort
Feasibility of Instrument: Count of CGM Instrument Issues
时间窗: After 4 participants (2 months)
After 4 participants (2 months), the study team will assess the number of instrument breaks
Mean Absolute Relative Difference for CGM and POC Glucose Measurements
时间窗: 10 months
Compare glucose measurements made by a Dexcom G4 Professional Continuous Glucose Monitor (CGM) against point of care glucose meter (Accu-Check Inform II, Roche Diagnostics), during the intraoperative and postoperative phases. Measured as mean absolute relative difference (MARD) for CGM glucose values compared with the POC glucose measurements.
次要结局
未报告次要终点
研究者
David Flum
Professor, School of Medicine: Surgery
University of Washington