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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom G6 continuous glucose monitor | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 continuous glucose monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 10 days |
| 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 | up to 10 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Volume Waste by Arterial Blood Gas | Blood sample amounts in milliliters required for measurement of glucose by arterial blood gas | Up to 10 days |
| Blood Volume Waste by Fingerstick | Blood sample amounts in milliliters required for measurement of glucose by fingerstick |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Cecilia Lansang, MD, MPH | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17216594 | Background | King TS, Chinchilli VM, Carrasco JL. A repeated measures concordance correlation coefficient. Stat Med. 2007 Jul 20;26(16):3095-113. doi: 10.1002/sim.2778. | |
| 23031487 | Background | Carrasco JL, Phillips BR, Puig-Martinez J, King TS, Chinchilli VM. Estimation of the concordance correlation coefficient for repeated measures using SAS and R. Comput Methods Programs Biomed. 2013 Mar;109(3):293-304. doi: 10.1016/j.cmpb.2012.09.002. Epub 2012 Sep 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Total matched observations vs. matched glucose measures | Posted | Number | matched clinical glucose measure | Up to 10 days | Total matched observations | Total matched observations |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dexcom site pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Numbness and pain on the same arm the device was placed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Parianos | Cleveland Clinc | 216-445-8354 | debsa@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2024 | Jul 17, 2024 | Prot_SAP_000.pdf |
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| Up to 10 days |
| 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 | Up to 10 days |
| 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 | Up to 10 days |
| 7873953 | Background | Bland JM, Altman DG. Calculating correlation coefficients with repeated observations: Part 1--Correlation within subjects. BMJ. 1995 Feb 18;310(6977):446. doi: 10.1136/bmj.310.6977.446. No abstract available. |
| 28439244 | Background | Bakdash JZ, Marusich LR. Repeated Measures Correlation. Front Psychol. 2017 Apr 7;8:456. doi: 10.3389/fpsyg.2017.00456. eCollection 2017. |
| 25562886 | Background | Klonoff DC, Lias C, Vigersky R, Clarke W, Parkes JL, Sacks DB, Kirkman MS, Kovatchev B; Error Grid Panel. The surveillance error grid. J Diabetes Sci Technol. 2014 Jul;8(4):658-72. doi: 10.1177/1932296814539589. Epub 2014 Jun 13. |
| years |
|
| Sex: Female, Male | Data was not collected for all participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data was not collected on 4 participants | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Data was not collected for all participants | Mean | Standard Deviation | kg/m2 |
|
| Participants with diabetes | Diabetes diagnosis can be type 1, type 2, or secondary (such as due to glucocorticoids or pancreatitis) | Data was not collected for all participants | Count of Participants | Participants |
|
| Surgery | Data was not collected for all participants | Count of Participants | Participants |
|
| Intravenous insulin use during surgery | Data was not collected for all participants | Count of Participants | Participants |
|
|
|
| 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 | matched clinical glucose measure | Posted | Number | matched clinical glucose measure | up to 10 days | Total matched glucose measures | Total matched glucose measures |
|
|
|
| Other Pre-specified | Blood Volume Waste by Arterial Blood Gas | Blood sample amounts in milliliters required for measurement of glucose by arterial blood gas | Not Posted | Up to 10 days | Participants |
| Other Pre-specified | Blood Volume Waste by Fingerstick | Blood sample amounts in milliliters required for measurement of glucose by fingerstick | Not Posted | Up to 10 days | Participants |
| 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 | No Cost saving analysis was performed | Posted | Up to 10 days |
|
|
| 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 | This outcome measure was not analyzed | Posted | Up to 10 days |
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| 0 |
| 29 |
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| 29 |
| 3 |
| 29 |
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