Bye bye, oval-shaped Dexcom Seven Plus continuous glucose monitor!
Hello, next generation Dexcom G4 Platinum CGM that's sleeker, more accurate and for sure looks more like an iPhone than a medical device (!)
Today, San Diego, CA-based Dexcom issued a news release announcing that its much-anticipated Dexcom G4 (generation 4) Platinum device has received FDA approval.
Along with the rest of the D-community, we've been watching anxiously for this for some time, especially after Dexcom filed with FDA in late March 2012 and the device launched in Europe over the summer. Now, the U.S. approval comes in less than 180 days — way to go on a speedy review process, FDA!
Dexcom CEO Terry Gregg says this record-time approval from the FDA on Friday caught the company by surprise, especially since many employees were overseas attending the EASD conference in Berlin. Gregg says that U.S. customers can start placing orders immediately and the new CGM will start shipping to new customers in just 10 days.
So what's different from the Dexcom Seven Plus?
- With the diameter of a human hair, the sensor is 60% smaller but, as before, provides updates every five minutes for up to 7 days.
- Clinical trial data shows that it's roughly 19% more accurate overall, and as much as 30% more accurate when blood sugars are in the "hypo-range" less than 70 mg/dL. That is HUGE, IMHO.
- Now, the egg-shaped receiver is replaced with a rectangle-shaped device reminiscent of an iPad Nano.
- The controls are laid out in an Apple-esque circle with the main button in the middle.
- A longer CGM sensor transmission range from the previous five feet to as much as 20 feet! (Hallelujah for people like me, who kept walking out of range all the time).
- Hypo alerts can be set at 55 mg/dL, rather than the standard 70 mg/dL common on all the available CGM devices currently.
- Aesthetically, it's just cool looking! Thin, modern, and of course with multi-colored options! ... which they are calling "tickled pink" and "ocean blue" (he, he), as well as the standard black:
- The LCD display gives you an "in-motion picture" showing not only glucose levels, but also the speed and direction in which one's BG is moving (with the well-known up and down arrows displayed at the top by the current BG level).
- With the longer distance range and improved technology, the new sensor will pick up more of your BG readings: they tell us 97% of your readings will now be captured, compared to the previous 89%. This means fewer gaps in data graphs.
- There are also customizable alerts letting you choose different tones — though the alarm demos online sound mostly like old Nintendo game tones; you cannot program your favorite songs or anything like that. Still, cool to have some options and the tutorial makes it look like it's easy to change with a quick button push.
Note that Seven Plus sensors aren't interchangeable with the new ones and won't work with this next-generation monitor. Effective immediately, the Seven Plus system will no longer be shipped to customers and will eventually be phased out completely, but the company will continue supporting the system for some time (no specific discontinuation date was given).
New companion software being introduced is called the Dexcom Studio, which will be web-based, so accessible online. The new Dex receiver has a built-in port for a universal USB connection, rather than their propriety Dexcom-specific cable that was required in the past. And some of the new data screens offer extra insight into BG patterns, with a new "portrait report" that is designed specifically to help users ID their trends.
The software is aimed at PC users, though Mac users who download the Windows operating system will also be able to employ it. Those who have the current Dexcom Data Manager 3 (DM3) loaded on their computers will be happy to know their data will be automatically updated into the new software system when they access Studio online.
Now on to your pressing questions:
The new G4 Platinum system will cost $1,198 for a starter kit with no sensors before insurance, which may sound like a lot but is only $50 more than the Seven Plus! (that cost $1,158). A four-pack of sensors would be $349. Dexcom reps told us today that the insurance coverage should remain the same, as billing codes have not changed.
The new Receiver will have a one-year warranty, same as the older version. However, the new Transmitter will only only carry a six-month warranty since it takes more battery life, the company tells us.
Naturally, an update program will be available for current Dexcom users. A rep told us by phone shortly after the news broke this morning that anyone who purchased a Dexcom before August 31, 2012, that's still under warranty would be eligible to upgrade for a one-time payment of $399. For those who just bought a Dexcom between Sept. 1 and Oct. 5, the upgrade would be free.
For those long-time Dexcom customers who might have a CGM that's out of warranty, there'll be no upgrade and a new purchase will be treated as a regular order through insurance or not. Dexcom also isn't currently offering any trade-in for older versions, or offering a free transmitter on trade-in as it has done before.
Can they really start filling new orders within weeks? CEO Terry Gregg says the company has been able to boost production overseas with the European launch, and that helps the company hit the ground running on new orders in the U.S. Already on the first day, Dexcom has had an "overwhelming response."
They are working to "coordinate new and existing customer orders"; for existing customers, they'll look at how recently that person last ordered sensors to determine how soon they'll need a new CGM. Overall, new customers will start seeing the new product within 10 days, while existing customers looking to upgrade will start receiving theirs in December.
As with the Seven Plus model, this current FDA approval is only for people with diabetes 17 and older, as the Dex isn't currently FDA-approved for the pediatric crowd. A separate submission for regulatory approval is being submitted on that, and Gregg said during a conference call that the company expects G4 filing for pediatric use yet this year or early 2013.
Why We're Excited
Watch this promotional video from Dexcom's website:
Who wouldn't be excited after watching that?
But really the excitement goes beyond this specific device, to the potential for further developments and integration. A number of insulin pump companies — Animas Ping, Insulet OmniPod, Tandem t-slim, the Roche Accu-chek Spirit and Roche's still-in-development Solo patch pump — have partnered Dexcom to work on integrating these pumps with the latest CGM technology.
We received a "no comment" from most of these partners when asked about possible timing on integrated products now that the Gen4 is approved. But at Animas, Global Communications Director Caroline Pavis did say that company is excited to hear about the G4 approval and that it's a priority now to submit their Vibe product with G4 sensor to the FDA.
During today's conference call, Gregg also said that Tandem was exploring how to integrate the G4 into future versions of its pump, rather than waiting on the Dex Gen5 sensor — another generation away! — that it has a contract to integrate.
On Gen5 development, Gregg said today that Dexcom is exploring technology that will "bypass a receiver and offer direct communication between a transmitter and smartphone." The company is also looking at a system that wouldn't require sensor calibration at all (yippee!).
So kudos to Dexcom for being on the forefront of CGM technology once again!
What about the competition? Industry analyst David Kliff notes in an update today: "Ironically the (Gen4) approval comes right after the EASD conference where it was learned that Abbott has re-launched their much beleaguered and given-up-for-dead continuous system, the Navigator.
"According to industry sources who attended the conference this silent launch in Europe was designed to test the waters on bringing an improved version of Navigator back to the U.S. Given that Dexcom and Medtronic currently dominate the CGM market and that Navigator has considerable baggage to overcome, Diabetic Investor doubts this new and improved version will gain much, if any, market traction."
Well, there you have it. Go Platinum!