FDA expands use of continuous glucose monitoring system
The Food and Drug Administration has expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring (CGM) system, which could eventually replace fingerstick blood glucose testing for diabetes treatment decisions in diabetic patients two years of age and older.
According to the regulatory agency, it is the first FDA-approved CGM system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test. Previously, the Dexcom system was cleared to complement—not replace—fingerstick testing for diabetes treatment decisions.
“The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions.
“This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management," added Gutierrez.
Dexcom’s G5 Mobile CGM System utilizes a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels, sending real-time results wirelessly every five minutes to a dedicated receiver and a compatible mobile device—such as the Apple iPhone—running a mobile app. In addition, alarms and alerts notify users when there are glucose levels above or below user-set thresholds.
While the system measures glucose in fluid under the skin that must be calibrated at least two times per day using blood obtained from fingerstick tests, Nicholas Argento, MD, an endocrinologist, says that additional daily fingerstick blood tests are generally no longer necessary because unlike other CGS systems, results from the device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test.
“We’ve seen CGM come from something that was sort of novel and experimental to now really being the standard of care,” adds Argento, who has Type 1 diabetes and personally uses the Dexcom CGM system. “What this system does is decreases the number of fingersticks and increases their level of blood sugar control by empowering patients to take action in a safe, discrete, accurate, and timely way.”
Argento notes that in addition to people with Type 1 diabetes there are a growing number of patients with Type 2 diabetes using the Dexcom G5 Mobile CGM System. He also makes the point that users of the system are able to designate “followers” such as family members with whom they can share the CGM data via the app.
“This is a huge benefit in particular for parents with young children and teenagers that are now starting to drive. The technology allows caregivers to have their back and serve as their backups,” according to Argento, who serves as the medical advisor to the diabetes program at 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 evaluated data from two clinical studies during which there were no serious adverse events were reported, according to the regulatory agency.
Nonetheless, the FDA issued a written statement that “risks associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions or where hardware or set-up issues disable alarms and alerts, as well as skin irritation or redness around the device’s adhesive patch.”
Further, the agency warned users that the system “must be calibrated using a fingerstick blood sample at least once every 12 hours and that taking any medications containing acetaminophen while wearing the system may falsely raise glucose readings.”