FDA expands the approved use of Continuous Glucose Monitoring System

The Food and Drug Administration (FDA) has expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring system or CGM system, which could instantly replace fingerstick blood glucose testing for diabetes treatment decisions in diabetic sufferers 2 years of age and older.

In accordance to the regulatory agency, it is the 1st FDA-approved Continuous Glucose Monitoring system that can be utilized to make diabetes treatment decisions without confirmation with a conventional fingerstick test. Initially, the Dexcom system was cleared to complement—not replace—fingerstick testing for diabetes treatment decisions.

“The FDA works really hard to assist ensure that novel technologies, which can decrease the burden of daily disease management, are safe and precise," stated Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "However this system still requires calibration with 2 daily fingersticks, it removes the requirement for any extra fingerstick blood glucose testing in order to make treatment decisions.

“This might permit some sufferers to handle their disease more comfortably and may motivate them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management," further added Gutierrez.

Dexcom’s G5 Mobile CGM System uses a small sensor wire inserted merely below the skin that continuously measures and monitors glucose levels, sending real-time results wirelessly every 5 minutes to a dedicated receiver and a compatible mobile device—like the Apple iPhone—running a mobile app. Additionally, alarms and alerts notify consumers when there are glucose levels above or below user-set thresholds.

While the system calculates glucose in fluid under the skin that must be calibrated almost 2 times each day using blood obtained from fingerstick tests, Nicholas Argento, MD, an endocrinologist, claims that extra daily fingerstick blood tests are generally no longer essential because unlike other CGS systems, results from the device can now be used straightly by sufferers to make diabetes treatment decisions without confirmation from a traditional fingerstick test.

“We have seen CGM come from something that was sort of novel and experimental to now actually being the standard of care,” further adds Argento, who has Type 1 diabetes and personally uses the Dexcom Continuous Glucose Monitoring system. “What this system does is reduce the number of fingersticks and increases their level of blood sugar control by motivating sufferers to take action in a safe, discrete, accurate, and timely way.”

Argento points out that in addition to individuals with Type 1 diabetes there are an increasing number of patients with Type 2 diabetes using the Dexcom G5 Mobile Continuous Glucose Monitoring System. He also makes the point that consumers of the system are capable to designate “followers” like family members with whom they can share the CGM data through the app.

“This is a key benefit in specific for parents with young kids and teenagers that are now starting to drive. The technology permits caregivers to have their back and serve as their backups,” in accordance to Argento, who serves as the medical advisor to the diabetes program at the Howard County General Hospital, a Johns Hopkins System hospital in Columbia, Md.

In making its decision to expand the approved use of the CGM system, the FDA verified data from 2 clinical studies during which there were no critical adverse events were reported, according to the regulatory agency.

Nevertheless, the FDA released a written statement that “risks associated with use of the system might involve hypoglycemia or hyperglycemia in cases where data provided by the device is wrong and utilized to make treatment decisions or where hardware or set-up issues disable alarms and alerts, as well as skin irritation or redness over the device’s adhesive patch.”

Moreover, the agency cautioned users that the system “must be calibrated utilizing a fingerstick blood sample at least once every twelve hours and that taking any medications containing acetaminophen while wearing the system might wrongly raise glucose readings.”