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Multicenter Study
. 2015 Jul;9(4):762-70.
doi: 10.1177/1932296815585872. Epub 2015 May 12.

Use of an Intravascular Fluorescent Continuous Glucose Sensor in ICU Patients

Paul J Strasma  1 , Simon Finfer  2 , Oliver Flower  3 , Brian Hipszer  4 , Mikhail Kosiborod  5 , Lewis Macken  3 , Marjolein Sechterberger  6 , Peter H J van der Voort  7 , J Hans DeVries  6 , Jeffrey I Joseph  4
Affiliations
Multicenter Study

Use of an Intravascular Fluorescent Continuous Glucose Sensor in ICU Patients

Paul J Strasma et al. J Diabetes Sci Technol. 2015 Jul.

Abstract

Background: Hyperglycemia and hypoglycemia are associated with adverse clinical outcomes in intensive care patients. In product development studies at 4 ICUs, the safety and performance of an intravascular continuous glucose monitoring (IV-CGM) system was evaluated in 70 postsurgical patients.

Methods: The GluCath System (GluMetrics, Inc) used a quenched chemical fluorescence mechanism to optically measure blood glucose when deployed via a radial artery catheter or directly into a peripheral vein. Periodic ultrasound assessed blood flow and thrombus formation. Patient glucose levels were managed according to the standard of care and existing protocols at each site. Reference blood samples were acquired hourly and compared against prospectively calibrated sensor results.

Results: In all, 63 arterial sensors and 9 venous sensors were deployed in 70 patients. Arterial sensors did not interfere with invasive blood pressure monitoring, sampling or other aspects of patient care. A majority of venous sensors (66%) exhibited thrombus on ultrasound. In all, 89.4% (1383/1547) of arterial and 72.2% (182/252) of venous measurements met ISO15197:2003 criteria (within 20%), and 72.7% (1124/1547) of arterial and 56.3% (142/252) of venous measurements met CLSI POCT 12-A3 criteria (within 12.5%). The aggregate mean absolute relative difference (MARD) between the sensors and the reference was 9.6% for arterial and 14.2% for venous sensors.

Conclusions: The GluCath System exhibited acceptable accuracy when deployed in a radial artery for up to 48 hours in ICU patients after elective cardiac surgery. Accuracy of venous deployment was substantially lower with significant rates of intravascular thrombus observed using ultrasound.

Keywords: continuous glucose monitoring; hospital; intensive care; intravascular.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: At the time of the study, PS was a full-time employee of GluMetrics, Inc. SF, OF, BH, MK, LM, MS, JV, PV, and JJ received research funding from GluMetrics, Inc. to conduct the clinical study. They did not own stock in GluMetrics, and they did not receive any other compensation. GluMetrics, Inc. ceased operations in 2014.

Figures

Figure 1.
Figure 1.
Calibration curve at varying temperatures.
Figure 2.
Figure 2.
Calibration curve at varying pH.
Figure 3.
Figure 3.
Schematic of the arterial GluCath sensor deployed via catheter.
Figure 4.
Figure 4.
Schematic of the venous GluCath sensor deployed intravascularly.
Figure 5.
Figure 5.
Arterial GluCath sensor housing.
Figure 6.
Figure 6.
Venous GluCath sensor.
Figure 7.
Figure 7.
GluCath monitor.
Figure 8.
Figure 8.
Ultrasound of arterial GluCath sensor.
Figure 9.
Figure 9.
Bland–Altman plot of 24-hour arterial cohort (N = 35, RNSH, OLVG, TJU).
Figure 10.
Figure 10.
Bland–Altman plot of 48-hour arterial cohort (N = 28, RNSH, OLVG).
Figure 11.
Figure 11.
Bland–Altman plot of 48-hour venous cohort (N = 9, RNSH, MAHI).
See this image and copyright information in PMC

References

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