OptiScan Biomedical has initiated the patient enrolment in a pivotal, multi-centre Investigational Device Exemption (IDE) clinical study of the OptiScanner 5000, a next-generation continuous monitoring platform for intensive care units (ICU).
The OptiScanner 5000, an automated, bedside glucose monitoring system, is designed to provide physicians with critical information to manage patient glucose levels in the ICU.
The pivotal trial, known as the MANAGE IDE study (Manual vs Automated moNitoring Accuracy of GlucosE IDE), is expected to enrol 200 patients at up to ten sites, mainly around the US.
The study's initial three clinical sites include: Washington University School of Medicine in St Louis, Missouri; Tufts University School of Medicine in Boston, Massachusetts; and St Luke's Mid-America Heart Institute in Kansas City, Missouri.
If successful, the company plans to use the fruitful results from the MANAGE IDE study for seeking US approval.
According to the company, approximately 20% of ICU patients have pre-existing diabetes and an additional 40% to 60% of ICU patients suffer from stress hyperglycaemia or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycaemic control.
The OptiScanner 5000 automates the measurement of patients' plasma glucose, as opposed to current manual measurement of glucose in whole blood and alerts clinicians to the existence of hyperglycemia (values that are too high) and hypoglycemia (values that are too low).
OptiScan Biomedical chairman and CEO Peter Rule said the initiation of this pivotal study of the OptiScanner 5000 represents a key milestone for OptiScan as the company continues efforts to bring the paradigm-shifting potential of this platform to critically ill patients and those ICU physicians responsible for their care.
"There is an acute need for breakthrough technologies that enable the automated, real-time monitoring of blood glucose in ICU patients in order to combat both the hyperglycemia and hypoglycemia that further complicate their already challenging health conditions," Rule said.
"Our extensive clinical research to date demonstrates the OptiScanner 5000's ability to safely and effectively meet these needs and we are eager to see the MANAGE IDE trial further corroborate those findings."
Based on the positive results from the MANAGE I and MANAGE II studies, OptiScan has started pivotal trial with the OptiScanner 5000 in the US.
These two previously completed trials were conducted at two European research centres and evaluated the OptiScanner 5000 used with very sick ICU patients.
Results from these two studies demonstrated the ability of the OptiScanner 5000 to combine accurate blood glucose measurement with the convenience of continuous, real-time bedside monitoring.
The company obtained CE Mark certification for its OptiScanner 5000 and initiated commercial efforts in the EU in 2014.