OptiScan Biomedical has initiated the patient enrollment in a pivotal, multi-center Investigational Device Exemption (IDE) clinical study of the OptiScanner 5000, a next-generation continuous monitoring platform for intensive care units (ICU).
The OptiScanner 5000 is an automated, bedside glucose monitoring system designed to provide physicians with critical information to manage patient glucose levels in the ICU.
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).
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.
The pivotal trial, known as the MANAGE IDE study (Manual vs. Automated moNitoring Accuracy of GlucosE IDE), is anticipated to enroll 200 patients at up to ten sites, most of which will be located in the US.
The trial is aimed to further demonstrate paradigm-shifting potential of automated, bedside glucose monitoring system in the ICU. If successful, the company plans to use the fruitful results from the MANAGE IDE study to support for approval in the US.
The company obtained CE mark certification for its OptiScanner 5000 and initiated commercial efforts in the EU in 2014.