The Development of a Continuous Intravascular Glucose Monitoring Sensor. 2015

Barry C Crane, and Nicholas P Barwell, and Palepu Gopal, and Mannam Gopichand, and Timothy Higgs, and Tony D James, and Christopher M Jones, and Alasdair Mackenzie, and Krishna Prasad Mulavisala, and William Paterson
GlySure Ltd, Abingdon, Oxon, UK bcrane@glysure.com.

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.

UI MeSH Term Description Entries
D007262 Infusions, Intravenous The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it. Drip Infusions,Intravenous Drip,Intravenous Infusions,Drip Infusion,Drip, Intravenous,Infusion, Drip,Infusion, Intravenous,Infusions, Drip,Intravenous Infusion
D007362 Intensive Care Units Hospital units providing continuous surveillance and care to acutely ill patients. ICU Intensive Care Units,Intensive Care Unit,Unit, Intensive Care
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D008991 Monitoring, Physiologic The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine. Patient Monitoring,Monitoring, Physiological,Physiologic Monitoring,Monitoring, Patient,Physiological Monitoring
D012015 Reference Standards A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy. Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D001786 Blood Glucose Glucose in blood. Blood Sugar,Glucose, Blood,Sugar, Blood
D002404 Catheterization Use or insertion of a tubular device into a duct, blood vessel, hollow organ, or body cavity for injecting or withdrawing fluids for diagnostic or therapeutic purposes. It differs from INTUBATION in that the tube here is used to restore or maintain patency in obstructions. Cannulation,Cannulations,Catheterizations
D003422 Critical Care Health care provided to a critically ill patient during a medical emergency or crisis. Intensive Care,Intensive Care, Surgical,Surgical Intensive Care,Care, Critical,Care, Intensive,Care, Surgical Intensive
D003920 Diabetes Mellitus A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

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