Like many of you, I woke up Monday morning to the news that the FDA had approved Dexcom’s newest generation continuous glucose monitoring system, the Dexcom G4 PLATINUM system. For me, it was a moment of mixed emotion: jubilation at finally being able to get my hands on this new system, which is already available in Europe and which I caught a tempting glance of at this year’s ADA conference. And frustration: I had JUST ordered a new shipment of sensors (after not doing so for months!) on Thursday, and since they already shipped, Dexcom will not take them back or refund my insurance company (okay, I get that there are legal restrictions on accepting returns on medical equipment, but still — the order arrived the day the announcement was made and I called 3 times to try to cancel).
But quibbles aside, this week is a very exciting one in the CGM market. The G4 Platinum is the first version of Dexcom’s system in the U.S. that may be integrated with other companies’ pumps (think the Animas Ping, Roche’s Accu-chek, Insulet’s Omnipod, and the Tandem T:Slim). We’re not talking artificial pancreases or closed loop systems — don’t get too excited — but developing technology to enable pumps and CGMs to talk to one another is one step closer to that goal. (And in the meantime this could add the convenience of being able to see your CGM value directly on the Dexcom screen, much like Minimed’s current Guardian system.)
But there are also major improvements to the system on its own, and this morning, Dexcom did a conference call with some members of the DOC so that we could ask questions about these upgrades. On the call were Dexcom CEO Terry Gregg (formerly of Minimed, he’s been working in the CGM field for an impressive 19 years), and Claudia Graham, VP of Marketing.
The call mostly focused on expanding upon the information included in the Dexcom press release, with some glimpses to the future and additional details thrown in. Here’s a run-down, combining the information from the press release with what happened on the call.
- Smaller sensor and longer range (the wire is the width of a human hair) that can transmit data to the receiver much further than the current version — presumably up to 20 feet, which may eliminate the frustration of getting an “out-of-range” indicator when you walk halfway across the room. (That’s four times the claimed distance for the Seven Plus; according to Gregg, they’ve seen it work up to 50 feet if it’s in an open space. And yes, they’ve attempted to protect it from hacking.) On the flipside, this increased range does come at a cost: it uses up the transmitter’s battery faster, and so the transmitter is only under warranty for six months instead of a year. But don’t freak out: Claudia Graham pointed out that when they get insurance approval for the Dexcom G4 Platinum system, it includes two transmitters. In her words, “We’re not really anticipating any issues on [insurance coverage of new transmitters] whatsoever.” [Update: I have spoken with a Dexcom rep about whether the part that sticks on your body is smaller, or if it's just the sensor wire itself. Turns out it's just the sensor wire. The transmitter -- i.e. the part above your skin -- is actually slightly thicker. A bummer, but again, the aforementioned improvements in sensor range and accuracy come at a cost.]
- BETTER ACCURACY (this is the big one). A reported 19 percent overall improvement over the current Seven Plus system, and an even better 30 percent improvement in the hypoglycemic range, defined as 70 mg/dl and below. Hallelujah!!
- A new data management software system called Dexcom Studio, which appears to be a big improvement over the previous version — you can play around with it here; Graham recommends checking out the “portrait” feature. The studio software also works with the Seven Plus system (very nice!), but unfortunately is still not easily Mac-compatible (you have to do the thing where you install dual operating systems on your computer so that your Mac can run as a PC just for this program). This means, unfortunately, that I will never use it. Which is unfortunate, because it sounds intriguing. The Studio was influenced by Sweet Spot, a data management company that Dexcom acquired earlier this year. According to Gregg, Sweet Spot will be the ones to eventually help those of us with Macs. (Future generations are going to be cloud-based, which will make it easier to see data, but they still need to figure out how people with Macs can get their numbers into the system to begin with.)
- Customizable alarm tones, and the ability to set your “low” indicator at 55 mg/dl rather than the normal 70 mg/dl
- Other things remain the same, like the impressive seven-day sensor life, with readings sent every five minutes. Also, Gregg confirmed that yes, the sensor really does get better a couple days into the session. It takes a while for the body’s inflammation response to settle down and for the system to be fully calibrated.
- Data display: The receiver is definitely better, with a color display and a much sleeker design (and it comes in colors — black, pink and blue). It also should be better in the rain (though it’s not waterproof, so don’t dunk your receiver in a toilet). While I appreciate these improvements, I am personally disappointed by the lack of changes in how data is displayed on the screen. Why can’t you scroll? Why must you smush? One thing I did notice, though, was that when you condense the screen to the 3-, 6-, 12-, and 24-hour views, there are now times displayed at the bottom of the screen, rather than just hash marks, making it possible at least to know at what time your blood sugar may have been somewhere between 180 and 220 mg/dl (since the line gets really thick as the graph condenses). May the next generation go even further! And may they ask me for suggestions! (I am a little obsessed with CGM data displays.)
As for insurance: The system doesn’t require new approval from your insurance company if you’re already on a CGM; if you’re paying out of pocket, it’s $1,198 for the starter system and $349 per box of four sensors. If you bought your Dexcom between Sept 1 and Oct 5, they’ll swap the new system for free; if you bought it before August 31st of this year and it’s still under warranty, you can upgrade for $399. (If it’s out of warranty you or your insurance company will have to cough up the money for a new one.)
And for new users? Gregg says they’re seeing new payers sign on every week, and that at this point most of the major insurance carriers in the country will cover CGMs for insulin-dependent diabetics (mostly Type 1, though they’ve recently seen some movement in Type 2, as well) — as Graham phrased it, they’ve achieved “probably nearly universal coverage with commercial payers for people with Type 1.” The amount of required documentation varies by insurance company, ranging from a simple letter of necessity from your doctor to documentation of hypoglycemic numbers. But the point is, it’s getting better. If you’ve held off on getting a CGM because you fear it’ll be an insurance nightmare, now might be the time to try.
As for timing, they’re taking orders now and expect to ship out the first systems within about two weeks. According to Gregg, the delay is not about inventory per se; they’re waiting for the product information/instruction material to come back from the printer so that they can include it with the system.
There also was a question about how long it took the FDA to approve this system, and Gregg spoke strongly in the FDA’s defense. While yes, it’s true that the original attempt to get a G4 system approved was filed in the summer of 2010, this current Dexcon G4 Platinum system is different, and much better — and the whole process is a result, he argues, of the FDA trying to do a better job. (He said that their experience with the FDA has been entirely positive, and that he’s been thrilled by the transparent and collaborative way they’ve worked together on this.) The Platinum system actually took fewer than 180 days for the FDA to approve — such a quick turnaround that Dexcom itself was surprised. They found out about the approval late Friday afternoon, when many of them were in Berlin attending a conference of the European Association of the Study of Diabetes meeting.
Lastly, Gregg pointed out that he’s very excited about this system, claiming that it’s the first CGM ever to fulfill what he considers the promise of CGM technology. But at the same time, there are improvements to be made (and promises yet to keep), and Dexcom has already started working on them. “I can’t tell you how excited I am when I see the data and then look to what we’ve got right waiting in the wings,” Gregg said. Already, Dexcom is working on both a G5 and G6 system, which include improvements like switching the “brains” from the receiver to the transmitter, which would enable data to be displayed on a multitude of devices, including smart phones. They are working on increasing the populations of patients for whom Dexcom is approved, including kids down to 2 years of age. But the ultimate goal, to which the G6 gets closer (it is down to single digit accuracy, says Gregg) is more exciting: they want to create a CGM that is so accurate, so reliable, that it eliminates the need for finger sticks entirely.
So, that’s the news at the moment. I already put an order in for a new G4 Platinum system, and will report back once I get my hands on it. In the meantime, thanks to both the FDA and to Dexcom for making this disease a little easier to live with.