FDA Decision on Dexcom Device Changes Playing Field for Continuous Glucose Monitoring
At the end of March, the U.S. Food and Drug Administration approved a new continuous glucose monitor (CGM) system, the Dexcom G6. The new sensor is smaller than current CGM devices, about the size of a quarter. It comes already calibrated from the factory, thus freeing users from daily finger sticks. It is formatted as a patch that enables 10 days of real-time tracking of the wearer’s blood glucose levels, with measurements taken at five-minute intervals. Most importantly, the G6 wirelessly provides a stream of data that enable the automatic delivery of insulin from a pump or other delivery device in response to rises in blood glucose levels.
The approval is noteworthy, as it is the first that the FDA has issued for a CGM that integrates with other devices, including insulin pumps, mobile apps, and artificial pancreas technologies, allowing the Dexcom G6 sensor to communicate with such devices regardless of their manufacturer. The FDA’s action is also a game-changer for similar devices, as the agency’s approval categorized the G6 as a “Moderate Risk” Class II Device and established certain controls that will enable future devices meeting those specifications to seek approval through the simpler “510(K)” clearance process. This move by the FDA means that future CGM sensors and closed loop systems, as well as data sharing platforms and system updates, will likely benefit from faster agency review turn-around times.
The FDA has stated that they aim to get new product advances into the hands of the diabetes community as quickly as possible. This action to expedite the review process for CGM systems is a large step in that direction, and has been applauded by members of the Type 1 Diabetes community, who will benefit from the FDA’s new policy.
Will the FDA extend similar policy changes to other integrated medical devices, we wonder. In what areas? What other regulatory changes should the agency be considering in order to more quickly get new and better medical technologies to patients?