GlySure gets CE mark for first continuous intravascular glucose monitor for hospital use

Managing blood glucose levels tightly helps improve morbidity and mortality rates among diabetics. That's particularly true for diabetics who have other major health problems. Now British startup GlySure has gained a CE mark specifically for use in intensive care units (ICUs) with adult cardiac surgery patients. Until now, blood glucose management for these critically ill patients often required frequent manual monitoring by the hospital staff.

GlySure's CIGMS--Courtesy of GlySure

Last year, the FDA released draft guidance for the first time separating out blood glucose monitors specifically for professional use in an institutional, hospital setting from those intended for at-home, consumer use. GlySure next plans to gain an FDA clearance for its Continuous Intravascular Glucose Monitoring System (CIGMS); it is currently designing a trial intended as the basis for an FDA submission. The device is also in a U.K.-based multi-center trial intended to enable a CE mark that extends across all adult ICU patients.

"Our first customers will lead the way in how glucose management is best practised, enabling improved patient outcomes and reduced healthcare costs," said GlySure COO Roger Moody in a statement. "Continuous glucose monitoring in critical care has been a vexing medical challenge. GlySure's game changing technology and elegant CIGMS solution will be the first in this market to deliver clinical value to patients and savings to healthcare providers."

A previous study has shown that maintaining an ICU patient's blood glucose level in the tight normal range can significantly reduce incidence of sepsis, renal failure, blood transfusions and even mortality by roughly one-half to one-third. More recently, another study found that maintaining blood sugar a bit on the high side but reducing hypoglycemic control events is more beneficial to ICU patients.

The GlySure CIGMS has three main parts: a monitor, a disposable fiber-optic sensor and a disposable 5-lumen central venous catheter--similar to that typically used in the ICU. It accurately measures intravascular blood glucose levels every 15 seconds. The system also comes with a three-point calibration system to ensure that it is correctly calibrated prior to use.

"For over a decade, the clinical community has been seeking a way to tightly control glucose levels in critically ill patients for both improved outcomes and reduced costs," Dr. Krishna Prasad, a consultant anesthesiologist at Care Hospitals, Nampally in Hyderabad, India, who was the principal investigator of the CIGMS CE mark trial, said in a statement. "GlySure's technology enables them to do this safely with accuracy, reliability and efficiency to support the implementation of improved glycemic control protocols."

- here is the release