Trial Outcomes & Findings for Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery (NCT NCT04569240)
NCT ID: NCT04569240
Last Updated: 2025-11-10
Results Overview
Glucose readings from the Dexcom continuous glucose monitor compared with blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to 10 days
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Dexcom G6 continuous glucose monitor
All patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings
Dexcom G6 continuous glucose monitor: Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
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|---|---|
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Overall Study
STARTED
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40
|
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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11
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was not collected for all participants
Baseline characteristics by cohort
| Measure |
Dexcom G6 Continuous Glucose Monitor
n=29 Participants
All patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings
Dexcom G6 continuous glucose monitor: Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
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|---|---|
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Age, Continuous
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58.2 years
STANDARD_DEVIATION 12.5 • n=29 Participants
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|
Sex: Female, Male
Female
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7 Participants
n=24 Participants • Data was not collected for all participants
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Sex: Female, Male
Male
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17 Participants
n=24 Participants • Data was not collected for all participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=25 Participants • Data was not collected on 4 participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=25 Participants • Data was not collected on 4 participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants • Data was not collected on 4 participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants • Data was not collected on 4 participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=25 Participants • Data was not collected on 4 participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=25 Participants • Data was not collected on 4 participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants • Data was not collected on 4 participants
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Region of Enrollment
United States
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29 Participants
n=29 Participants
|
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Body Mass Index
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30.2 kg/m2
STANDARD_DEVIATION 4.9 • n=25 Participants • Data was not collected for all participants
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|
Participants with diabetes
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25 Participants
n=25 Participants • Data was not collected for all participants
|
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Surgery
aortic valve replacement/ascending
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9 Participants
n=25 Participants • Data was not collected for all participants
|
|
Surgery
Bentall
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2 Participants
n=25 Participants • Data was not collected for all participants
|
|
Surgery
coronary artery bypass graft
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4 Participants
n=25 Participants • Data was not collected for all participants
|
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Surgery
coronary artery bypass graft/extended
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6 Participants
n=25 Participants • Data was not collected for all participants
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|
Surgery
mitral valve replacement
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1 Participants
n=25 Participants • Data was not collected for all participants
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|
Surgery
Myectomy
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1 Participants
n=25 Participants • Data was not collected for all participants
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Surgery
Pericardiectomy
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1 Participants
n=25 Participants • Data was not collected for all participants
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Surgery
right ventricular assist device
|
1 Participants
n=25 Participants • Data was not collected for all participants
|
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Intravenous insulin use during surgery
|
16 Participants
n=25 Participants • Data was not collected for all participants
|
PRIMARY outcome
Timeframe: Up to 10 daysPopulation: Total matched observations vs. matched glucose measures
Glucose readings from the Dexcom continuous glucose monitor compared with blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter
Outcome measures
| Measure |
Dexcom G6 continuous glucose monitor
n=817 Total matched observations
All patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings
Dexcom G6 continuous glucose monitor: Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
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|---|---|
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Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements)
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817 matched clinical glucose measure
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PRIMARY outcome
Timeframe: up to 10 daysPopulation: matched clinical glucose measure
Glucose readings in mg/dL from the Dexcom continuous glucose monitor (CGM) will be compared with fingerstick point of care glucose levels in mg/dL
Outcome measures
| Measure |
Dexcom G6 continuous glucose monitor
n=817 Total matched glucose measures
All patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings
Dexcom G6 continuous glucose monitor: Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
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|---|---|
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Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose
Total matched observations
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817 matched clinical glucose measure
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Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose
Matched fingerstick measures
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280 matched clinical glucose measure
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 daysBlood sample amounts in milliliters required for measurement of glucose by arterial blood gas
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 daysBlood sample amounts in milliliters required for measurement of glucose by fingerstick
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 daysPopulation: No Cost saving analysis was performed
Cost of CGMS device including sensor, transmitter versus cost of doing an ABG to obtain glucose levels (CVICU stay), and versus the cost of Accu-chek Inform II meter, test strips, and lancets
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 daysPopulation: This outcome measure was not analyzed
time it takes to perform and time it takes to have results based on an ABG or fingerstick POC on Accu-check Inform II
Outcome measures
Outcome data not reported
Adverse Events
Dexcom G6 continuous glucose monitor
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexcom G6 continuous glucose monitor
n=29 participants at risk
All patients will have a Dexcom G6 continuous glucose monitor placed pre-operatively. The glucose readings will be collected for 10 days or upon discharge from the ICU and data will be compared with arterial blood glucose readings or venous Accu-Check Inform II glucose readings
Dexcom G6 continuous glucose monitor: Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
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|---|---|
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Musculoskeletal and connective tissue disorders
Dexcom site pain
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10.3%
3/29 • 1 year
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place