Surgery--Complications
Conditions
Brief summary
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the cardiovascular intensive care unit (CVICU), and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors.
Detailed description
Maintaining tight blood glucose control following surgery is imperative to reducing infections and neurologic dysfunction. This requires frequent blood sampling while in the intensive care unit, leading to increased waste of blood and utilizing time and resources to collect samples and wait for results. Additionally, when on the regular floors, frequent point of care fingersticks for glucose levels are needed for therapeutic intervention. Continuous glucose monitoring systems (CGMS) are now available for ambulatory use in patients with diabetes. The potential of using such a system in the hospital, including during the postoperative critical care setting and upon transfer to the regular floor, may reduce personnel burden, produce rapid results, and decrease blood waste. However, these systems have not yet been validated for hospital use. This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the CVICU, and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems will be calculated, and error will be classified using the Surveillance Error grid. The proportion of errors of at least moderate risk will be calculated. Subject characteristics including demographics, comorbidities and baseline disease severity will be summarized using means and standard deviations for continuous measures and frequencies and percentages for categorical factors. To evaluate agreement between methods, concordance correlation coefficients will be calculated, using the method that adjusts for repeated measures as described by King and implemented in software by Carrasco. Analysis will be performed overall, and then stratifying by type of current measure, if the type of measurement varies across settings. Correlations will be calculated using the methods described by Bland and Altman and implemented by Bakdash and Marusich. Differences will also be evaluated for errors according to the Surveillance Error Grid. Rates of moderate or more severe errors will be calculated. For each measure above, 95% confidence intervals will be calculated, accounting for the clustering within subject.. Analyses will be performed using SAS software (version 9.4; Cary, NC) and R software (version 3.5; Vienna Austria). Glucose readings obtained from the CGMS will be compared with 1. blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter if arterial catheter not in use (standard of care in CVICU) while patients are in the CVICU 2. fingerstick point of care (POC) glucose when patients are on the regular floors
Interventions
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.
Sponsors
DexCom, Inc.
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and above * Planned cardiovascular surgery * Planned admission to Cleveland Clinic Main Campus J5 or J6 or Q5 cardiovascular ICU (CVICU) post-operatively * With or without known diabetes; if with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary
Exclusion criteria
* Allergy to the material of the CGMS or the adhesive to be used * Skin conditions precluding the use of the CGMS * Pregnancy * Other conditions that investigators deem inappropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements) | Up to 10 days | Glucose readings from the Dexcom continuous glucose monitor compared with blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter |
| Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose | up to 10 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Volume Waste by Arterial Blood Gas | Up to 10 days | Blood sample amounts in milliliters required for measurement of glucose by arterial blood gas |
| Blood Volume Waste by Fingerstick | Up to 10 days | Blood sample amounts in milliliters required for measurement of glucose by fingerstick |
| Cost Savings: | Up to 10 days | 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 |
| Time Savings | Up to 10 days | time it takes to perform and time it takes to have results based on an ABG or fingerstick POC on Accu-check Inform II |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Dexcom G6 Continuous Glucose Monitor |
|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 12.5 |
| Body Mass Index | 30.2 kg/m2 STANDARD_DEVIATION 4.9 |
| Intravenous insulin use during surgery | 16 Participants |
| Participants with diabetes | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 17 Participants |
| Surgery aortic valve replacement/ascending | 9 Participants |
| Surgery Bentall | 2 Participants |
| Surgery coronary artery bypass graft | 4 Participants |
| Surgery coronary artery bypass graft/extended | 6 Participants |
| Surgery mitral valve replacement | 1 Participants |
| Surgery Myectomy | 1 Participants |
| Surgery Pericardiectomy | 1 Participants |
| Surgery right ventricular assist device | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 3 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose
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
Time frame: up to 10 days
Population: matched clinical glucose measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 continuous glucose monitor | Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose | Total matched observations | 817 matched clinical glucose measure |
| Dexcom G6 continuous glucose monitor | Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose | Matched fingerstick measures | 280 matched clinical glucose measure |
Primary
Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements)
Glucose readings from the Dexcom continuous glucose monitor compared with blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter
Time frame: Up to 10 days
Population: Total matched observations vs. matched glucose measures
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexcom G6 continuous glucose monitor | Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements) | 817 matched clinical glucose measure |
Other Pre-specified
Blood Volume Waste by Arterial Blood Gas
Blood sample amounts in milliliters required for measurement of glucose by arterial blood gas
Time frame: Up to 10 days
Other Pre-specified
Blood Volume Waste by Fingerstick
Blood sample amounts in milliliters required for measurement of glucose by fingerstick
Time frame: Up to 10 days
Other Pre-specified
Cost Savings:
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
Time frame: Up to 10 days
Population: No Cost saving analysis was performed
Other Pre-specified
Time Savings
time it takes to perform and time it takes to have results based on an ABG or fingerstick POC on Accu-check Inform II
Time frame: Up to 10 days
Population: This outcome measure was not analyzed