Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery

Diabetes Mellitus Clinical Trial

— GluPop  

Official title:

Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery — an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935919
• Other study ID #: GluPop
• Status: Completed
• Start date: August 13, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Aged =18 years

• Pre-diabetic (HbA1c 5.7-6.5%) or diabetic (regardless of aetiology)

• Scheduled to have elective abdominal surgery at the University Hospital Bern

• Surgery duration >2 hours

Exclusion criteria:

• Planned MRI procedure during hospitalization

• Inability to follow procedures

• Incapacity to give informed consent

• Presence of extensive skin abnormalities at the sensor insertion site (upper arm)

• Known allergic/irritative skin reactions to dressings/adhesives

• Haematocrit values outside the normal range

• Patients with immunosuppression defined as neutrophil count <0.5x10^9/L

• Patients on isolation precautions (contact, droplet, airborne)

• Pregnancy or breast-feeding

Related Conditions & MeSH terms

• Diabetes Mellitus
• Prediabetes
• Prediabetic State

Locations

Country	Name	City	State
Switzerland	Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensor accuracy in the perioperative period	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 (%)	1 day
Secondary	Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)	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 (%)	1 week
Secondary	Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)	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 (%)	1-2 weeks
Secondary	Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)	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 (%)	1 week
Secondary	Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)	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 (%)	1 day
Secondary	Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)	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 (%)	1-2 weeks
Secondary	Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria	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 (%)	1 week
Secondary	Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria	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 (%)	1 day
Secondary	Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria	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 (%)	1-2 weeks
Secondary	Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period	Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period	1 week
Secondary	Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period	Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period	1 day
Secondary	Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period	Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period	1-2 weeks
Secondary	Clarke error grid analysis in the preoperative period	Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E)in the preoperative period (%)	1 week
Secondary	Clarke error grid analysis in the perioperative period	Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the perioperative period (%)	1 day
Secondary	Clarke error grid analysis in the postoperative period	Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the postoperative period (%)	1-2 weeks
Secondary	Sensor availability in the preoperative period (%)	Proportion of study period with available sensor glucose values in the preoperative period	1 week
Secondary	Sensor availability in the perioperative period (%)	Proportion of study period with available sensor glucose values in the perioperative period	1 day
Secondary	Sensor availability in the postoperative period (%)	Proportion of study period with available sensor glucose values in the postoperative period	1-2 weeks
Secondary	Number of sensor replacement events in the preoperative period	Number of times that the sensor needed to be replaced in the preoperative period	1 week
Secondary	Number of sensor replacement events in the perioperative period	Number of times that the sensor needed to be replaced in the perioperative period	1 day
Secondary	Number of sensor replacement events in the postoperative period	Number of times that the sensor needed to be replaced in the postoperative period	1-2 weeks
Secondary	Number of adverse device effects in the preoperative period	Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the preoperative period	1 week
Secondary	Number of adverse device effects in the perioperative period	Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the perioperative period	1 day
Secondary	Number of adverse device effects in the postoperative period	Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the postoperative period	1-2 weeks
Secondary	Percentage of time in the preoperative period with sensor glucose levels within target range	Proportion of time in the preoperative period with sensor glucose levels between 3.9-10.0mmol/l	1 week
Secondary	Percentage of time in the perioperative period with sensor glucose levels within target range	Proportion of time in the perioperative period with sensor glucose levels between 3.9-10.0mmol/l	1 day
Secondary	Percentage of time in the postoperative period with sensor glucose levels within target range	Proportion of time in the postoperative period with sensor glucose levels between 3.9-10.0mmol/l	1-2 weeks
Secondary	Percentage of time in the preoperative period with sensor glucose levels below target range	Proportion of time in the preoperative period with sensor glucose levels below 3.9mmol/l	1 week
Secondary	Percentage of time in the perioperative period with sensor glucose levels below target range	Proportion of time in the perioperative period with sensor glucose levels below 3.9mmol/l	1 day
Secondary	Percentage of time in the postoperative period with sensor glucose levels below target range	Proportion of time in the postoperative period with sensor glucose levels below 3.9mmol/l	1-2 weeks
Secondary	Percentage of time in the preoperative period with sensor glucose levels above target range	Proportion of time in the preoperative period with sensor glucose levels above 10.0mmol/l	1 week
Secondary	Percentage of time in the perioperative period with sensor glucose levels above target range	Proportion of time in the perioperative period with sensor glucose levels above 10.0mmol/l	1 day
Secondary	Percentage of time in the postoperative period with sensor glucose levels above target range	Proportion of time in the postoperative period with sensor glucose levels above 10.0mmol/l	1-2 weeks
Secondary	Mean sensor glucose value in the preoperative period	Mean value of the sensor glucose levels in the preoperative period	1 week
Secondary	Mean sensor glucose value in the perioperative period	Mean value of the sensor glucose levels in the perioperative period	1 day
Secondary	Mean sensor glucose value in the postoperative period	Mean value of the sensor glucose levels in the postoperative period	1-2 weeks
Secondary	Standard deviation of sensor glucose levels in the preoperative period	Standard Deviation of the sensor glucose levels in the preoperative period	1 week
Secondary	Standard deviation of sensor glucose levels in the perioperative period	Standard Deviation of the sensor glucose levels in the perioperative period	1 day
Secondary	Standard deviation of sensor glucose levels in the postoperative period	Standard Deviation of the sensor glucose levels in the postoperative period	1-2 weeks