Clinical trial NCT03935919: Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery
Official title: Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Prediabetes
Keywords: perioperative glucose management
continuous glucose monitoring
diabetes
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will involve a total of 20 adults with pre-diabetes, type 1 or type 2 diabetes who will undergo elective abdominal surgery at the 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensor accuracy in the perioperative period
timeFrame: 1 day
Secondary outcomes:
measure: Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)
timeFrame: 1 week
measure: Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)
timeFrame: 1-2 weeks
measure: Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)
timeFrame: 1 week
measure: Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)
timeFrame: 1 day
measure: Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)
timeFrame: 1-2 weeks
measure: Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria
timeFrame: 1 week
measure: Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria
timeFrame: 1 day
measure: Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria
timeFrame: 1-2 weeks
measure: Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period
timeFrame: 1 week
measure: Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period
timeFrame: 1 day
measure: Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period
timeFrame: 1-2 weeks
measure: Clarke error grid analysis in the preoperative period
timeFrame: 1 week
measure: Clarke error grid analysis in the perioperative period
timeFrame: 1 day
measure: Clarke error grid analysis in the postoperative period
timeFrame: 1-2 weeks
measure: Sensor availability in the preoperative period (%)
timeFrame: 1 week
measure: Sensor availability in the perioperative period (%)
timeFrame: 1 day
measure: Sensor availability in the postoperative period (%)
timeFrame: 1-2 weeks
measure: Number of sensor replacement events in the preoperative period
timeFrame: 1 week
measure: Number of sensor replacement events in the perioperative period
timeFrame: 1 day
measure: Number of sensor replacement events in the postoperative period
timeFrame: 1-2 weeks
measure: Number of adverse device effects in the preoperative period
timeFrame: 1 week
measure: Number of adverse device effects in the perioperative period
timeFrame: 1 day
measure: Number of adverse device effects in the postoperative period
timeFrame: 1-2 weeks
measure: Percentage of time in the preoperative period with sensor glucose levels within target range
timeFrame: 1 week
measure: Percentage of time in the perioperative period with sensor glucose levels within target range
timeFrame: 1 day
measure: Percentage of time in the postoperative period with sensor glucose levels within target range
timeFrame: 1-2 weeks
measure: Percentage of time in the preoperative period with sensor glucose levels below target range
timeFrame: 1 week
measure: Percentage of time in the perioperative period with sensor glucose levels below target range
timeFrame: 1 day
measure: Percentage of time in the postoperative period with sensor glucose levels below target range
timeFrame: 1-2 weeks
measure: Percentage of time in the preoperative period with sensor glucose levels above target range
timeFrame: 1 week
measure: Percentage of time in the perioperative period with sensor glucose levels above target range
timeFrame: 1 day
measure: Percentage of time in the postoperative period with sensor glucose levels above target range
timeFrame: 1-2 weeks
measure: Mean sensor glucose value in the preoperative period
timeFrame: 1 week
measure: Mean sensor glucose value in the perioperative period
timeFrame: 1 day
measure: Mean sensor glucose value in the postoperative period
timeFrame: 1-2 weeks
measure: Standard deviation of sensor glucose levels in the preoperative period
timeFrame: 1 week
measure: Standard deviation of sensor glucose levels in the perioperative period
timeFrame: 1 day
measure: Standard deviation of sensor glucose levels in the postoperative period
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital, University Hospital of Bern, University of Bern
name: Lia Bally, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: