Intravascular System Monitors Glucose Continuously

An innovative continuous intravascular glucose monitoring system (CIGMS) addresses an unmet need for uninterrupted glucose monitoring in the intensive care unit (ICU).

The GlySure CIGMS is comprised of a monitor, a sterile sensor set that includes an integrated fiber-optic sensor/introducer, and a fully automated calibration module. The sensor interfaces with the ICU patient's central venous catheter (CVC) line, without disrupting the ability to monitor pressure, draw blood, or administer medication through the same CVC lines. The fiberoptic sensor provides accurate intravascular glucose measurements every fifteen seconds, thus providing continual feedback to help clinicians avoid dangerous fluctuations in glucose levels.

The core of the technology is fluorophore-receptor indicator chemistry, provided via a specifically configured diboronic acid receptor that is covalently linked to the fluorophore. The receptor is continuously excited by a specific wavelength of pulsed light emitted from light emitting diodes (LEDs) located in the monitor. When blood glucose diffuses through the outer membrane of the receptor to the optical cell and binds to the diboronic acid receptor, there is an increase in fluorescence which is proportional to the glucose concentration.

The reaction between the receptor and glucose is reversible (no glucose is consumed), enabling accurate and continuous long term monitoring. To provide maximum accuracy, the fiberoptic sensor is shipped connected to a sterile and fully automated calibration module. Once the calibrator is inserted into the monitor, it performs an automated three point calibration prior to use. The sensor-calibrator is a closed system that maintains sterility throughout calibration. The GlySure CIGMS is a product of Glysure (Abingdon, United Kingdom), and has received the European Community CE marking of approval.

“We are pleased to bring to market the first practical solution to address this significant unmet medical need. Our first customers will lead the way in how glucose management is best practiced, enabling improved patient outcomes and reduced healthcare costs,” said Roger Moody, CEO of GlySure. “Continuous glucose monitoring in critical care has been a vexing medical challenge; GlySure’s game changing technology and elegant solution will be the first in this market to deliver clinical value to patients and savings to healthcare providers.”

Studies have shown that controlling patient glucose levels in the ICU within tight normal ranges yielded significant improvements in patient outcomes, including a 46% reduction in incidence of sepsis, 41% reduction in renal failure, a 50% reduction in blood transfusions, and 34% reduction in mortality.

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