Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery - an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sensor accuracy in the perioperative period
研究概览
简要总结
The purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability.
详细描述
The current recommended method for monitoring glucose control is bedside point of care capillary blood glucose testing. A significant limitation for this method is the frequency by which blood glucose testing is typically performed, at most 4-6 times daily. Continuous glucose monitoring (CGM) provides an alternative approach to measure glucose values with the advantage of greater frequency of monitoring as it is measured every few minutes.
Whilst CGM use in the outpatient setting is rising and has demonstrated benefits on glycaemic control, the accuracy of these devices perioperatively is less investigated. In this study the sixth-generation factory-calibrated real-time Dexcom G6® system will be used as a CGM and its glucose values perioperatively will be compared to the capillary glucose values which will be measured simultaneously by the Accu-Check Inform II (Roche Diagnostics) point-of-care blood glucose meter.
The Investigators aim to assess the feasibility and accuracy of perioperative CGM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensor accuracy in the perioperative period
时间窗: 1 day
Mean Absolute Relative Difference (MARD) between Dexcom G6 sensor glucose values and capillary blood glucose values measured using the Accu-Check Inform II meter in the perioperative period (%)
次要结局
- Clarke error grid analysis in the postoperative period(1-2 weeks)
- Sensor availability in the perioperative period (%)(1 day)
- Number of adverse device effects in the perioperative period(1 day)
- Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)(1 week)
- Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period(1 week)
- Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)(1 week)
- Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)(1-2 weeks)
- Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria(1-2 weeks)
- Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period(1 day)
- Clarke error grid analysis in the perioperative period(1 day)
- Percentage of time in the postoperative period with sensor glucose levels below target range(1-2 weeks)
- Percentage of time in the perioperative period with sensor glucose levels above target range(1 day)
- Clarke error grid analysis in the preoperative period(1 week)
- Percentage of time in the postoperative period with sensor glucose levels within target range(1-2 weeks)
- Standard deviation of sensor glucose levels in the postoperative period(1-2 weeks)
- Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)(1-2 weeks)
- Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria(1 week)
- Number of sensor replacement events in the postoperative period(1-2 weeks)
- Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)(1 day)
- Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria(1 day)
- Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period(1-2 weeks)
- Sensor availability in the postoperative period (%)(1-2 weeks)
- Number of sensor replacement events in the preoperative period(1 week)
- Number of sensor replacement events in the perioperative period(1 day)
- Number of adverse device effects in the preoperative period(1 week)
- Percentage of time in the preoperative period with sensor glucose levels within target range(1 week)
- Percentage of time in the perioperative period with sensor glucose levels within target range(1 day)
- Standard deviation of sensor glucose levels in the perioperative period(1 day)
- Sensor availability in the preoperative period (%)(1 week)
- Number of adverse device effects in the postoperative period(1-2 weeks)
- Percentage of time in the preoperative period with sensor glucose levels below target range(1 week)
- Percentage of time in the preoperative period with sensor glucose levels above target range(1 week)
- Percentage of time in the postoperative period with sensor glucose levels above target range(1-2 weeks)
- Mean sensor glucose value in the postoperative period(1-2 weeks)
- Standard deviation of sensor glucose levels in the preoperative period(1 week)
- Percentage of time in the perioperative period with sensor glucose levels below target range(1 day)
- Mean sensor glucose value in the preoperative period(1 week)
- Mean sensor glucose value in the perioperative period(1 day)