Glucose monitoring system cleared for use in hospital critical care units

A new indication for the Nova StatStrip Glucose Hospital Meter System (Nova Biomedical) has been cleared by FDA. The agency has extended its use to hospitalized patients who are critically ill.

This is the first FDA clearance of a blood glucose monitoring system (BGMS) for use in these patients and of a device indicated for use in all different types of hospital patients, including the critically ill. The BGMS was found by FDA to be easy to use, with a low risk for false results.

As a BGMS it is a handheld device used to measure the amount of glucose in the blood through analysis of a small drop of the patient’s blood placed on a test strip. The BGMS displays a reading of the glucose level after the test strip is inserted into the device.

FDA also granted waived test system status under the Clinical Laboratory Improvement Amendments (CLIA). Healthcare professionals like nurses and technicians will be allowed to perform the test at the point-of-care where a patient is (eg, hospital bedside) versus requiring it be performed in a setting that meets CLIA requirements for high complexity testing such as a hospital lab. As well, the waiver will allow blood glucose monitoring to be safely provided by hospital labs for critically ill patients without needing to meet the requirements for high complexity testing under CLIA.

Underpinning FDA clearance were data gathered from a study of more than 1650 patients with a variety of medical conditions and medications who were being treated in different hospital departments like cardiac, emergency intensive care, and surgical departments. In all of the various types of patients being tested, study results found agreement in blood glucose results versus a comparator laboratory glucose analyzer.

The FDA clearance covers indications for using arterial or venous whole blood from patients hospitalized with conditions including trauma, cancer, sepsis, and infection; cardiac, kidney, neurologic, obstetric, gynecologic, gastroenterologic, endocrine, and lung problems; and those who are recovering from general or cardiothoracic surgery.