Clinical trial NCT04569240: Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery
Official title: Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2020-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements)
timeFrame: Up to 10 days
measure: Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose
timeFrame: up to 10 days
Secondary outcomes:
measure: Cost Comparison of Dexcom CGMS Versus Blood Glucose Testing
timeFrame: Up to 10 days
measure: Cost Comparison of Dexcom CGMS Versus Fingerstick Point of Care Glucose
timeFrame: Up to 10 days
Other outcomes:
measure: Blood Volume Waste by Arterial Blood Gas
timeFrame: Up to 10 days
measure: Blood Volume Waste by Fingerstick
timeFrame: Up to 10 days
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: M. Cecilia Lansang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Bakdash JZ, Marusich LR. Repeated Measures Correlation. Front Psychol. 2017 Apr 7;8:456. doi: 10.3389/fpsyg.2017.00456. eCollection 2017.
citation: 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.