Dexcom G7 continuous glucose monitor system seemingly nears European launch as the next-gen CGM awaits FDA clearance
Millions of continuous glucose monitor (CGM) users are anxiously awaiting the G7 system from Dexcom. Its G6 CGM system has proved to be very popular, offering discreet glucose monitoring and management around the clock for users with type 1 or type 2 diabetes while also doing away with annoying fingersticks for the most part. The Dexcom G7 promises numerous improvements over its predecessor, including being 60% smaller, delivering a much quicker warm-up time (30 min vs. 120 min for the G6), and combining the transmitter and sensor.
It appeared the COVID-19 pandemic ruined the release schedule for the disposable Dexcom G7 CGM, with its actual launch date being pretty much a mystery. However, it is possible that Dexcom expects the ball to start rolling very soon, as a Google search for the G7 reveals a locked page that had already been created for the monitor. While the current page is blank, the Google search description offers some clues:
Dexcom G7 receives CE Mark – Introducing the Dexcom G7 CGM System…The next-generation Dexcom G7 can make diabetes management powerfully simple with a small, all-in-one wearable sensor and…
The locked web page has been cached by Google, so it can still be seen, with screenshots provided below for those curious about the G7 CGM. The Dexcom G7 was expected to receive the CE Mark required for production and sales in the European Economic Area at the end of 2021, which can be corroborated by the upload date (Dec 21) of the unlisted "forward-looking" statement video that is also embedded below. FDA approval for the Dexcom G7 may come in 2022, although as the company’s CEO Kevin Sayer pointed out in a recent interview, the FDA is unsurprisingly giving priority to COVID-19-related projects at the moment.
The G7 is expected to be a disposable 10-day sensor with potential for extension to 14 days, and it will transmit continuous glucose level measurements to nearby connected smart devices. The recent clinical study showed that Dexcom G7 blood sugar readings were +/- 20% of a confirmed result produced using the fingerstick method for 93% of the time, taken from 300 participants amassing 39,000 readings. Cost is unknown, but the Dexcom G6 costs about US$3,800 a year, so the G7 could be similar. The good news is that Medicare has expanded its insurance coverage in regard to CGM devices.