Next month the FDA is hosting a public advisory committee meeting to discuss a change to the intended use of Dexcom's G5 Mobile Continuous Glucose Monitoring System (CGM) device that would allow the company to market the G5 as a CGM patients can base treatment decisions on.
Currently, Dexcom's CGMs are considered adjunctive devices, which means they carry an asterisk that notes they are intended to be used for tracking and trending interstitial fluid glucose concentrations, but not as a replacement for fingerstick blood glucose meters, which patients still need to use for treatment decisions, even if they use a CGM.
CGMs also require fingerstick tests for calibration, and the G5's user manual says it should be calibrated at least every twelve hours -- or twice a day.
Dexcom's EVP of Strategy and Product Development Steve Pacelli has indicated in the past that convincing the FDA to remove the adjunctive label would likely lead to an increase in adoption of CGMs and could also increase the likelihood that CMS would consider reimbursing for them.
"Initially, I think our belief was that the dosing claim was most important from a Medicare perspective, because Medicare has indicated that until we get the adjunctive labeling removed, that they would not entertain a coverage category for CGM," Pacelli said last year. "This is, again, all anecdotal from our sales force, but these doctors would be much more willing when they don't have to tell their patients that they have to take a confirmatory fingerstick, to prescribe much more. So, I think the dosing claim could actually be a bigger catalyst than maybe we had anticipated in the past."
Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the transmitter. It sends glucose data directly to a smartphone, so users don't have to carry a separate receiver device. Data from the CGM can be sent to iOS devices, including the Apple Watch. The device got premarket approval from the FDA last August.
"To grow a business this fast, you have to have new thing after new thing after new thing that enhances the patient experience to get deeper into the patient community," Dexcom CEO Kevin Sayer said on an earnings call last summer. "Gen 5 is that next step. We believe the data going straight to a phone will enable patients not to carry an extra thing around in their pocket and will be very helpful. But we also know the next step after that: we have to make it more convenient, we have to eliminate calibrations and the hassle factor, and we have to continue to maintain our excellent level of accuracy. All those things matter, and we address every one of those things every time we iterate."
Last fall news broke that Dexcom had partnered with Verily, known as Google Life Sciences at the time, to develop the next generation of Dexcom's CGM — a device that would be “the size of a dime”, less expensive than current CGMs, and that the companies hope will eventually replace the fingerstick glucometer. The companies expect the device to be used by people with Type 1 diabetes as well as those with Type 2 diabetes.