In amazingly fast timing that rises to the level of historic, the FDA has approved the next-generation Dexcom G5 continuous glucose monitor (CGM) system that will communicate directly with a mobile device and doesn't require the separate receiver to actually be used!
The California CGM company announced the news Tuesday morning, almost a week after regulators had made the actual approval decision. Dexcom submitted the G5 for regulatory review on Feb. 25, so it took the FDA less than six months to give this next-gen CGM the green light. Seriously, that's quick!
The press release boasts: "With wireless Bluetooth technology built into the device transmitter, the G5 Mobile... is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year."
For advanced data sharing and analysis, they’ve also unveiled a new cloud-based software and mobile app package they’re calling Dexcom CLARITY.
And they’re exercising bragging rights that Dexcom makes the most accurate CGM sensors available, with the only single-digit MARD (mean absolute relative difference) score out there (9% per clinical data; remember, the lower the result, the higher the accuracy).
Pretty exciting stuff!
The new transmitter model with built-in Bluetooth is about the size of the original G4 transmitter (before the thinner model released last year), Dexcom tells us. Of course the new model includes the advanced 505 software that FDA approved in October.
Other than that, the main differences between the current G4 and new G5 models are functional, we’re told. The user interface for the G5 receiver is modified slightly to reflect the brand new user interface in the app, and of course users will now be able to calibrate the system directly from their phone, and also log events like food, exercise and other activities that impact your blood sugar. You can also have the low and high alerts sent to your phone as text messages, allowing for more discretion than loud alarms.
From web images, it looks like the receiver itself has a reversed color scheme, with a white screen and black text and lines displayed, instead of the other way around.
For those not hip to what the Dexcom G4 Platinum and now the G5 offer as to basics, here's a glimpse:
- 7 days of wear (as dictated by FDA, but many of us find we can extend that to 10 days or longer)
- Blood sugar readings are updated every 5 minutes
- Low and High thresholds can be adjusted, but the Dexcom CGM has a pre-set hypo alert at 55 mg/dL that can't be changed
- You have to calibrate the device with fingersticks a small number of times per day -- although now the G5 will allow you to do so directly via phone app!
Some important notes on the new G5:
Yes, it is kid-friendly! It’s quite newsworthy that for the first time, a new CGM is cleared for both adults and kids as young as 2 years old simultaneously. Devices are typically approved for adults first, and the pediatric designations come later following additional clinical studies. D-parents may want to send some love out to Dexcom for working to make this happen immediately!
Receivers will come with the package. We're told the FDA is requiring Dexcom to send a receiver to all new patients who start on the G5, so they have one as an option or fallback, regardless of whether they wish to use it (now not necessary because the transmitter talks directly to the phone).
Remote Receiver Updates: If you already have a Dexcom G4 with Share receiver, then you can choose to keep your current receiver and instead simply upload a firmware update to make it compatible with the G5. That way, there's an option if you don't want to buy more than the new G5 transmitters.
Transmitter life. Also, the new G5 transmitters will only last about three months and will shut off after 112 days, unlike the current G4 that has a six-month warranty but many of us have found can last much longer than that. Dexcom's higher-ups tell us their engineers designed this G5 to have a 90-day transmitter with a 2 or 3 week grace period, meaning it will actually shutdown on day 112 allowing more time to get a new transmitter. You'll get two in a box each time you order new transmitters.
We asked Dexcom's head of strategy and corporate development Steve Pacelli about the new cloud-based Dexcom CLARITY system that's part of this G5 launch. He tells us it is a development project of SweetSpot, which Dexcom acquired in 2012 and has been hinting that there's more on that coming soon. We’re anxious ourselves to get a closer look at this new app and data platform.
The CLARITY software will be provided to G5 customers for free, with no additional subscription or charge for using that.
Update: More information is out there on Dexcom CLARITY, including this post from D-Mom Lorraine Sisto. Just like with the current G4 Share system, the G5 Mobile will allow users to share data with up to 5 different people through its "Share" and "Follower" apps. Unfortunately, for the time being, it will only be compatible with iOS devices.
Given Dexcom’s existing Share app for the Apple Watch, the G5 will be able compatible with that wearable wrist gadget too.
Dexcom says it will be rolling out Android compatibility coming early next year. The delay is probably also a symptom of the FDA moving so quickly, as Dexcom was likely planning to have more time to develop the Android app. Oh, well. Another six months or so isn't too bad, right?
Availability & Cost
Dexcom says the G5 will be available in late September, and while costs are TBD, there will be upgrade offers available to those who've recently bought the G4 tech or are still under warranty:
- If you purchased a G4 Platinum with Share system between Juy 25, 2015, and the time the G5 starts shipping, you will be eligible to receive a no-cost upgrade to this new G5 mobile system.
- For customers still under warranty with their Dexcom existing system, the company will offer a “low-cost cash upgrade” to the G5. If you bought one between May 25 and July 24 (2015), the cost is $299 and includes two new G5 transitters. If you purchased between Feb. 25 and May 24, 2015, the cost is $199 and includes one G5 transmitter.
Dexcom itself seems surprised at how quickly this all has moved.
"Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3-2015 earnings call in early November," said CEO Kevin Sayer in a published statement.
Chalk it up to Dexcom being extremely good at communicating and working with the FDA, for which they have received a lot of kudos in the industry.
They’ve been able to say "approved more quickly than expected" on a number of other product approvals in the past years -- from the original G4 sensor that was OK’d in less than 180 days, to the mobile Dexcom SHARE tech that got approval at the start of this year after only a few months.
This turns out to be great timing for Dexcom on the competitive front, since this G5 approval beats out the expected Fall release of the Medtronic Minimed Connect system that will offer improved mobile connectivity for Medtronic’s pump-CGMs combo products (though theirs still requires a separate uploader). No exact timing on when that's coming, but Medtronic says it should be in the next few months.
This G5 approval is also exciting for the companies Dexcom is partnering with on next-gen tech -- although the Animas Vibe combo system with built-in G4 that was released early this year and the Tandem t:slim-G4 combo that's awaiting FDA approval won't be immediately impacted by this new G5 technology. But presumably the new combo system under development with OmniPod-maker Insulet would skip over the G4 and be directly compatible with the new G5.
Dexcom has also signed an agreement with data-sharing group Tidepool to integrate CGM data into their new open data platform and apps when they become available, hopefully sometime in the coming months.
No matter how you slice it, we appear to be on the fast track to getting new options for managing our diabetes with the most cutting-edge tools!
That’s fantastic news for Dexcom, for the diabetes industry at large, and for all of us in the patient community too!