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Comparative Study
. 2015 Jul;9(4):751-61.
doi: 10.1177/1932296815587937. Epub 2015 Jun 1.

The Development of a Continuous Intravascular Glucose Monitoring Sensor

Barry C Crane  1 , Nicholas P Barwell  2 , Palepu Gopal  3 , Mannam Gopichand  4 , Timothy Higgs  5 , Tony D James  6 , Christopher M Jones  2 , Alasdair Mackenzie  2 , Krishna Prasad Mulavisala  3 , William Paterson  2
Affiliations
Comparative Study

The Development of a Continuous Intravascular Glucose Monitoring Sensor

Barry C Crane et al. J Diabetes Sci Technol. 2015 Jul.

Abstract

Background: Glycemic control in hospital intensive care units (ICU) has been the subject of numerous research publications and debate over the past 2 decades. There have been multiple studies showing the benefit of ICU glucose control in reducing both morbidity and mortality. GlySure Ltd has developed a glucose monitor based on a diboronic acid receptor that can continuously measure plasma glucose concentrations directly in a patient's vascular system. The goal of this study was to validate the performance of the GlySure CIGM system in different patient populations.

Methods: The GlySure Continuous Intravascular Glucose Monitoring (CIGM) System was evaluated in both the Cardiac ICU (33 patients) and MICU setting (14 patients). The sensor was placed through a custom CVC and measured the patients' blood glucose concentration every 15 seconds. Comparison blood samples were taken at 2 hourly then 4 hourly intervals and measured on a YSI 2300 STAT Plus or an i-STAT.

Results: Consensus error grid analysis of the data shows that the majority of the data (88.2% Cardiac, and 95.0% MICU) fell within zone A, which is considered to be clinically accurate and all data points fell within zones A and B. The MARD of the Cardiac trial was 9.90% and the MICU trial had a MARD of 7.95%. Data analysis showed no significant differences between data generated from Cardiac and MICU patients or by time or glucose concentration.

Conclusions: The GlySure CIGM System has met the design challenges of measuring intravascular glucose concentrations in critically ill patients with acceptable safety and performance criteria and without disrupting current clinical practice. The accuracy of the data is not affected by the patients' condition.

Keywords: boronic acid; continuous glucose; 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: BCC, NPB, CMJ, AM, and WP are full-time employees of GlySure Ltd.

Figures

Figure 1.
Figure 1.
(A) Clinician’s view of patients’ blood glucose concentration (formula image) based on intermittent blood sample measurements (formula image); samples 7 and 8 are highlighted (formula image). (B) CGM (-) versus intermittent blood sample measurements.
Figure 2.
Figure 2.
Integrating the errors associated with the intermittent samples.
Figure 3.
Figure 3.
Use model GlySure CIGM System.
Figure 4.
Figure 4.
Cross section of sensor tip.
Figure 5.
Figure 5.
Binding of glucose switches the fluorescence of the receptor “on” upon binding.
Figure 6.
Figure 6.
Example data from the (A) Cardiac trial using a YSI as a comparison device and (B) MICU trial using an i-STAT as a comparison device.
Figure 7.
Figure 7.
(A) Consensus error grid analysis; (B) Bland–Altman chart; (C) MARD versus time; (D) MARD versus glucose range. °/– Cardiac trial, °/– MICU trial.
Figure 8.
Figure 8.
Histogram of errors for Cardiac and MICU patients.
Figure 9.
Figure 9.
Histogram of errors (A) versus time and (B) versus glucose concentration range.
Figure 10.
Figure 10.
Sensor after removal from a patient.
See this image and copyright information in PMC

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