Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery
- Conditions
- PrediabetesDiabetes Mellitus
- Registration Number
- NCT03935919
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensor accuracy in the perioperative period 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 (%)
- Secondary Outcome Measures
Name Time Method Clarke error grid analysis in the postoperative period 1-2 weeks Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the postoperative period (%)
Sensor availability in the perioperative period (%) 1 day Proportion of study period with available sensor glucose values in the perioperative period
Number of adverse device effects in the perioperative period 1 day Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the perioperative period
Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%) 1 week Mean absolute relative difference between sensor glucose and reference glucose (for reference values \>3.9 and \<10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the preoperative period (%)
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period 1 week Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period
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 (for reference values \>3.9 and \<10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the preoperative period (%)
Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%) 1-2 weeks Median absolute relative difference between sensor glucose and reference glucose (for reference values \>3.9 and \<10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the postoperative period (%)
Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria 1-2 weeks Proportion of sensor measurements in the postoperative period within ±15% of reference glucose if the reference value is ≥5.6mmol/l and within 0.8mmol/l if the reference values is \<5.6mmol/l (%)
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period 1 day Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period
Clarke error grid analysis in the perioperative period 1 day Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the perioperative period (%)
Percentage of time in the postoperative period with sensor glucose levels below target range 1-2 weeks Proportion of time in the postoperative period with sensor glucose levels below 3.9mmol/l
Percentage of time in the perioperative period with sensor glucose levels above target range 1 day Proportion of time in the perioperative period with sensor glucose levels above 10.0mmol/l
Clarke error grid analysis in the preoperative period 1 week Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E)in the preoperative period (%)
Percentage of time in the postoperative period with sensor glucose levels within target range 1-2 weeks Proportion of time in the postoperative period with sensor glucose levels between 3.9-10.0mmol/l
Standard deviation of sensor glucose levels in the postoperative period 1-2 weeks Standard Deviation of the sensor glucose levels in the postoperative period
Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%) 1-2 weeks Mean absolute relative difference between sensor glucose and reference glucose (for reference values \>3.9 and \<10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the postoperative period (%)
Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria 1 week Proportion of sensor measurements in the preoperative period within ±15% of reference glucose if the reference value is ≥5.6mmol/l and within 0.8mmol/l if the reference values is \<5.6mmol/l (%)
Number of sensor replacement events in the postoperative period 1-2 weeks Number of times that the sensor needed to be replaced in the postoperative period
Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%) 1 day Median absolute relative difference between sensor glucose and reference glucose (for reference values \>3.9 and \<10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the perioperative period (%)
Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria 1 day Proportion of sensor measurements in the perioperative period within ±15% of reference glucose if the reference value is ≥5.6mmol/l and within 0.8mmol/l if the reference values is \<5.6mmol/l (%)
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period 1-2 weeks Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period
Sensor availability in the postoperative period (%) 1-2 weeks Proportion of study period with available sensor glucose values in the postoperative period
Number of sensor replacement events in the preoperative period 1 week Number of times that the sensor needed to be replaced in the preoperative period
Number of sensor replacement events in the perioperative period 1 day Number of times that the sensor needed to be replaced in the perioperative period
Number of adverse device effects in the preoperative period 1 week Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the preoperative period
Percentage of time in the preoperative period with sensor glucose levels within target range 1 week Proportion of time in the preoperative period with sensor glucose levels between 3.9-10.0mmol/l
Percentage of time in the perioperative period with sensor glucose levels within target range 1 day Proportion of time in the perioperative period with sensor glucose levels between 3.9-10.0mmol/l
Standard deviation of sensor glucose levels in the perioperative period 1 day Standard Deviation of the sensor glucose levels in the perioperative period
Sensor availability in the preoperative period (%) 1 week Proportion of study period with available sensor glucose values in the preoperative period
Number of adverse device effects in the postoperative period 1-2 weeks Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the postoperative period
Percentage of time in the preoperative period with sensor glucose levels below target range 1 week Proportion of time in the preoperative period with sensor glucose levels below 3.9mmol/l
Percentage of time in the preoperative period with sensor glucose levels above target range 1 week Proportion of time in the preoperative period with sensor glucose levels above 10.0mmol/l
Percentage of time in the postoperative period with sensor glucose levels above target range 1-2 weeks Proportion of time in the postoperative period with sensor glucose levels above 10.0mmol/l
Mean sensor glucose value in the postoperative period 1-2 weeks Mean value of the sensor glucose levels in the postoperative period
Standard deviation of sensor glucose levels in the preoperative period 1 week Standard Deviation of the sensor glucose levels in the preoperative period
Percentage of time in the perioperative period with sensor glucose levels below target range 1 day Proportion of time in the perioperative period with sensor glucose levels below 3.9mmol/l
Mean sensor glucose value in the preoperative period 1 week Mean value of the sensor glucose levels in the preoperative period
Mean sensor glucose value in the perioperative period 1 day Mean value of the sensor glucose levels in the perioperative period
Trial Locations
- Locations (1)
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
🇨🇭Bern, Switzerland