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Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery (GluPop)

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ClinicalTrials.gov Identifier: NCT03935919
Recruitment Status : Completed
First Posted : May 2, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease
Diabetes Mellitus Prediabetes

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery - an Observational Study
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : March 1, 2020



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935919


Locations
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Switzerland
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lia Bally, MD PhD Inselspital, University Hospital of Bern, University of Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03935919    
Other Study ID Numbers: GluPop
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
perioperative glucose management
continuous glucose monitoring
diabetes
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases