The FDA expands indication for a glucose monitoring system to replace finger-stick blood glucose testing for patients at least 2 years old who are being treated for diabetes.
The G5 Mobile Continuous Glucose Monitoring System (Dexcom, Inc) received expanded approval from the US Food and Drug Administration (FDA) to replace finger-stick blood glucose testing for patients 2 years and older who are being treated for diabetes.
The FDA said this is the first approval of a glucose monitoring system that can be used to make decisions about diabetes treatment without needing additional confirmation with traditional finger stick tests.
“Although this system still requires calibration with two daily finger sticks, it eliminates the need for any additional finger stick blood glucose testing in order to make treatment decisions,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health in a news release.
To evaluate the efficacy of G5 Mobile Continuous Glucose Monitoring System, the FDA assessed data from two clinical studies of that included 130 adults and children two years and older with diabetes. Researchers compared blood glucose meter values in seven-day periods. There were no serious adverse events reported. However, some associated risks could be skin irritation or redness surrounding the device’s adhesive patch, and experts warn against taking medications with acetaminophen when wearing the system to avoid inaccurate levels of glucose readings.
Until now, patients with diabetes were required to regularly monitor their blood sugar by typically taking blood samples from their fingertips and testing them against blood glucose meters. The meter would show whether they had hyperglycemia (high glucose levels) or hypoglycemia (low glucose levels). Those levels affect treatment decisions.
The new system uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels, sending real-time results to compatible mobile devices. At specific blood glucose levels, the device can emit alarms.
The device system eliminates the need for additional finger stick blood tests.
According to Gutierrez, “This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogues with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management.”