FDA Expands Blood Glucose Monitoring System Indication

Officials with the FDA have expanded the use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people 2 years of age and older with diabetes, according to a press release from the administration.

This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.

"Although this system still requires calibration with 2 daily fingersticks, it eliminates the need for any additional fingerstick 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. "This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management."

The FDA evaluated data from two clinical studies of the G5 Mobile Continuous Glucose Monitoring System. These studies included 130 adults and children aged 2 years and older with diabetes. All studies included a seven-day period where system readings were compared to blood glucose meter values, as well as to a laboratory test method that measures glucose values. No serious adverse events were reported during the studies.

The G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every 5 minutes to a dedicated receiver and a compatible mobile device (eg, smart phone or tablet) running a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds. The system measures glucose in fluid under the skin and must be calibrated at least 2 times per day using blood obtained from fingerstick tests. However, additional daily fingerstick blood tests are generally no longer necessary because unlike other continuous glucose monitoring systems, results from this device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test.

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.