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Completed

NCT Number: NCT03935919

Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensor accuracy in the perioperative period

    Time frame: 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 outcomes

  1. Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)

    Time frame: 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 (%)

  2. Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)

    Time frame: 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 (%)

  3. Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)

    Time frame: 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 (%)

  4. Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)

    Time frame: 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 (%)

  5. Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)

    Time frame: 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 (%)

  6. Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria

    Time frame: 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 (%)

  7. Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria

    Time frame: 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 (%)

  8. Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria

    Time frame: 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 (%)

  9. Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period

    Time frame: 1 week

    Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period

  10. Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period

    Time frame: 1 day

    Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period

  11. Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period

    Time frame: 1-2 weeks

    Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period

  12. Clarke error grid analysis in the preoperative period

    Time frame: 1 week

    Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E)in the preoperative period (%)

  13. Clarke error grid analysis in the perioperative period

    Time frame: 1 day

    Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the perioperative period (%)

  14. Clarke error grid analysis in the postoperative period

    Time frame: 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 (%)

  15. Sensor availability in the preoperative period (%)

    Time frame: 1 week

    Proportion of study period with available sensor glucose values in the preoperative period

  16. Sensor availability in the perioperative period (%)

    Time frame: 1 day

    Proportion of study period with available sensor glucose values in the perioperative period

  17. Sensor availability in the postoperative period (%)

    Time frame: 1-2 weeks

    Proportion of study period with available sensor glucose values in the postoperative period

  18. Number of sensor replacement events in the preoperative period

    Time frame: 1 week

    Number of times that the sensor needed to be replaced in the preoperative period

  19. Number of sensor replacement events in the perioperative period

    Time frame: 1 day

    Number of times that the sensor needed to be replaced in the perioperative period

  20. Number of sensor replacement events in the postoperative period

    Time frame: 1-2 weeks

    Number of times that the sensor needed to be replaced in the postoperative period

  21. Number of adverse device effects in the preoperative period

    Time frame: 1 week

    Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the preoperative period

  22. Number of adverse device effects in the perioperative period

    Time frame: 1 day

    Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the perioperative period

  23. Number of adverse device effects in the postoperative period

    Time frame: 1-2 weeks

    Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the postoperative period

  24. Percentage of time in the preoperative period with sensor glucose levels within target range

    Time frame: 1 week

    Proportion of time in the preoperative period with sensor glucose levels between 3.9-10.0mmol/l

  25. Percentage of time in the perioperative period with sensor glucose levels within target range

    Time frame: 1 day

    Proportion of time in the perioperative period with sensor glucose levels between 3.9-10.0mmol/l

  26. Percentage of time in the postoperative period with sensor glucose levels within target range

    Time frame: 1-2 weeks

    Proportion of time in the postoperative period with sensor glucose levels between 3.9-10.0mmol/l

  27. Percentage of time in the preoperative period with sensor glucose levels below target range

    Time frame: 1 week

    Proportion of time in the preoperative period with sensor glucose levels below 3.9mmol/l

  28. Percentage of time in the perioperative period with sensor glucose levels below target range

    Time frame: 1 day

    Proportion of time in the perioperative period with sensor glucose levels below 3.9mmol/l

  29. Percentage of time in the postoperative period with sensor glucose levels below target range

    Time frame: 1-2 weeks

    Proportion of time in the postoperative period with sensor glucose levels below 3.9mmol/l

  30. Percentage of time in the preoperative period with sensor glucose levels above target range

    Time frame: 1 week

    Proportion of time in the preoperative period with sensor glucose levels above 10.0mmol/l

  31. Percentage of time in the perioperative period with sensor glucose levels above target range

    Time frame: 1 day

    Proportion of time in the perioperative period with sensor glucose levels above 10.0mmol/l

  32. Percentage of time in the postoperative period with sensor glucose levels above target range

    Time frame: 1-2 weeks

    Proportion of time in the postoperative period with sensor glucose levels above 10.0mmol/l

  33. Mean sensor glucose value in the preoperative period

    Time frame: 1 week

    Mean value of the sensor glucose levels in the preoperative period

  34. Mean sensor glucose value in the perioperative period

    Time frame: 1 day

    Mean value of the sensor glucose levels in the perioperative period

  35. Mean sensor glucose value in the postoperative period

    Time frame: 1-2 weeks

    Mean value of the sensor glucose levels in the postoperative period

  36. Standard deviation of sensor glucose levels in the preoperative period

    Time frame: 1 week

    Standard Deviation of the sensor glucose levels in the preoperative period

  37. Standard deviation of sensor glucose levels in the perioperative period

    Time frame: 1 day

    Standard Deviation of the sensor glucose levels in the perioperative period

  38. Standard deviation of sensor glucose levels in the postoperative period

    Time frame: 1-2 weeks

    Standard Deviation of the sensor glucose levels in the postoperative period

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: GluPop

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 2, 2019
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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