Dexcom Files New Gen 4 Sensor with FDA; Approval Optimistically Expected by the End of 2012
Earlier in May, we were encouraged to hear that Dexcom has filed its new Gen 4 CGM sensor with the FDA. The review process typically takes six months or longer, meaning Dexcom might even see FDA approval of the new sensor before the end of 2012. As a reminder, the original Gen 4 sensor was approved in Europe in March 2011 (see new now next in diaTribe #31), though we understand that the US version has several incremental improvements over the currently available Gen 4 sensor in Europe (sold as part of the Animas Vibe integrated pump/CGM). Here in the US, Dexcom has been encouraged by early interactions with the FDA thus far, and we certainly hope this continues as the Gen 4 makes its way through the regulatory process. We’ll be excited to give it a test drive once it becomes available (see diaTribe #15 for our test drive of the Dexcom Seven Plus). For those across the Atlantic, Dexcom is planning to launch the new updated Gen 4 CGM in Europe later this summer.
The new Gen 4 sensor is expected to be over 20% more accurate and 25% better in hypoglycemia detection relative to the current Seven Plus. The Gen 4 transmitter will also have a much longer communication range with the receiver – up to 30 feet normally and up to 50 feet (!) if it’s in line of sight, compared to a range of five feet cited in the label for the Seven Plus. Dexcom’s new sensor will feature a new receiver design as well, including a color screen, slimmer profile, and a different navigation interface. Down the road, the Gen 4 will also be integrated into the Animas Vibe and Insulet OmniPod insulin pumps, though Dexcom has not yet disclosed a timeline on when these might be filed with the FDA. –AB