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.
Here is the FDA approval letter, and a regulatory agency overview of the 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 Software!
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:
Cost?
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.
Warranty?
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.
Upgrading?
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.
Timing?
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.
Adults Only
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!
As someone whose only used a competitor’s CGM, I’m naturally intrigued about this and wondering if there is an opportunity to use it on a trial basis before taking the plunge. I wonder if Dex has any such program, or if I need to go through my endo to try to find a loaner (which is quite unlikely, I suspect!)
Actually your Endo/Diabetes Educator should lend you one but bcause of huge demand you may have to wait a while. I have borrowed every device from mine before I bought a pump or a CGM.
Now if only we had this integrated with the pump and a separate receiver for parents – then I’d really be excited!
Hi Amy, Love the blog! Would kill for a Dexcom
Just wondering if it’d be ok for me to post a link or widget for my petition for Medicare to cover CGM’s-which at this time they DO NOT-here? Thanks for all the info!
Petition to CMS? Tried an Appeal???
The accuracy is now not good enough to use for Bolus. It may never be but they are trying.
[...] Monitoring System) if I'm not mistaken this will be tied with several different insulin pumps http://www.diabetesmine.com/2012/10/…ed-by-fda.html Check your blood Sugar and go for a ride. Ivan __________________ US AirForce – Retired 1974 [...]
Way to go Dexcom! I want my blue right now!
I marvel at what Dexcom has achieved from the beginning. Every updated generation has been substantive and no sooner is one generation launched, they are already working on the next one. Is there any more improvement to be squeezed out of chemical sensor technology?!
I wish they would allow multiple alert settings for different times of day. If Dexcom hasn’t implemented it by now, I guess they never will. A minor nit but I’d also like the 1 hour screen to be the default or better yet, let us choose the default.
Does anyone know how often insurance will usually cover a new CGMS? Mine is out of warranty but not 2 years old yet.
While any new approval is exciting, could someone please tell me how the following is different from the SevenPlus with this regard:
•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).
Not to be nit-picky, but the improvement in data gaps should probably be a sub-section of the transmission range, unless it is a sensor improvement.
Do we know for a fact that the SevenPlus won’t work, or to ask it another way, are the sensors compatible with a Seven Plus transmitter?
Can you use the different tones with different volumes?
I find it funny that they are excited about being able to program hypo ranges below 70. What about for different times of day like at night?
Does anyone else get annoyed with the 55 alert being hard-wired? I would prefer a predictive alert, which would have been really nice in this.
Does it have the same insertion as the Seven Plus?
While I am excited about the accuracy, size of the receiver, and increased range, the 6 month warranty/life on the transmitter is not exciting and it just seems to be color Seven Plus.
The Studio previews show a different looking screen that also has a pattern identification screen for trends and such. Data gap improvement was said to be a result of both range and better technology changes. Personally, I’m a fan of the 55 versus 70 alert. This has predictive alerts: that’s the whole point of the Low and High alerts and arrows: not just to ell where where you are but where you’re going. Yes, the sound samples in the Dex website indicate there’s volume control on the tones. And as written in the post based on what we asked- the new sensors won’t work with the Seven Plus and old sensors won’t work with new G4 system.
I should preface this with the fact that have used navigator, medtronic, and Dexcom CGMs.
The first part of my comment isn’t about Studio, it is about the LCD on the monitor and the point was that it is nothing new.
The greater flexibility in the low range is nice, but I just find it funny since other manufacturers (medtronic and navigator if I remember correctly) have had that flexibility for some time and even more so since I know Medtronic (I have their pump but no longer use their CGM) has the ability to change the range by the time (great for when you are sleeping).
I’m not sure who told you it has predictive alerts, but in their call with investors yesterday they explicitly said there are no predictive alerts.
Since you brought up the software, I might as well comment on that as well. DM3 has always been interesting to me. They do some cool things with it, but I have always seen it as a doctors tool. Why do I mention DM3? Because Studio is merely a face lift of it plus that new report. Having played with the report thanks to the backwards compatibility, I actually find it offensive to my intelligence as it adds very little insight in my opinion.
Again, I love that it is something new and they have made some nice improvements, but take everything at face value.
God has spoken…
Thanks for the write up. I can’t wait for the future generations from Dexcom.
Dexcom looks great! Thanks for your entry.
My Dexcom rep told me the new G4 was not FDA approved for “multiple users” so I don’t think the company will be able to offer loaners for people to try before purchase, as they did in the past. For this reason, the G4 won’t be used for professional CGM in medical offices. We have to continue to use our Seven for that. There seems to be a heightened safety concern at FDA these days regarding medical equipment which is passed on from one patient to another.
Im interested in obtaining the new dexcom cgm…is it covered by medicare/medicaid?
Just contacted Dexcom about an upgrade (I’ve been a user/proud supporter of the Dexcom 7 system for many years, paying out of pocket for my sensors since my insurance plan won’t cover).
I was informed by Customer Service that since my original purchase was over 2 years ago, that I am not eligible for an upgrade and would have to pay the full price of $1198 for an upgrade!!!???
Are you kidding me? Is this how a company treats it’s long term customers?
Although I would love to have the new system and be able to adjust the alarm alerts so that my highs don’t set off air raid level-decibel alarms, I will not be eager to fork over another grand to a company that cares little about it’s long term customers, especially those who pay out of pocket.
Hope there’s a competitor soon.
My two cents,
Rob
I’ve been wearing the new sensor since Wednesday and I LOVE it.
More accurate than my 7+, better range (I can shower and run around the house getting ready for work and not get ‘lost’) and more accurate.
It is not for multiple users, so no trials before you buy. Relax. It’s worth it. And they will still return it after 30 days if you don’t like it.
Again. I love it. Will not even lend to a friend.
[...] appealing displays has sure been catching on! The new VerioIQ meter from OneTouch and the brand new DexCom G4 Continuous Glucose Monitor both have full-color, bright displays that rival the display of the newest smartphones and are [...]
I don’t understand Ellen Cooper’s Dexcom rep’s assertion that the G4 was not approved for “multiple users.” The approval letter says that it is intended for single patient use and requires a prescription, but that does not preclude single patient use AT A TIME. Serial monogamy is not the same as polygamy, after all.
The only part of the Seven Plus and G4 that touches the PWD is the hair-like sensor that must be inserted with a SINGLE-USE tool. There’s no medical reason I can think of that would justify preventing a provider from loaning the transmitter and receiver, with one (or more) sensors, to prospective users to try out before committing to a particular device.
I’ve heard it said that “There is logic and then there is FDA logic.” The FDA has a tough job in that they have to balance patient safety and efficacy. They have also become very conservative over the past decade for various reasons (e.g. vioxx). However, your analogy of serial monogamy and polygamy does not work in this case. In this case “single patient use” is for the entire system. If you really want to get technical, I don’t think the Seven Plus actually had “multiple patient” labeling, it just didn’t have “single-patient” labeling.
Obviously the sensor itself can’t be used on multiple patients, but I think their concern is the transmitter and monitor. First, the transmitter may get blood on it since a needle does go into the skin. I think it is probably extremely unlikely, but I guess there is a risk. The other risk is just general germs. Hospitals are hotbeds for germs, viruses, diseases, etc There have been studies that have shown in a matter of a week how contaminated a stuffed animal can become in a pediatric center.
Don’t think I am necessarily sticking up for the FDA, more like playing devil’s advocate and clarifying their position. I personally think they are effing crazy and way to conservative. If it wasn’t for political pressure their requirements for artificial pancreas studies would be so high few no company would have gone after it. It was only with a ton of political pressure that they brought their requirements to a reasonable level. If you think about it, Medtronic has had the Veo out in Europe for more than a couple years now so why can’t they use that real world patient data to submit that it is safe?
Anyone else want the soap box?
You may be right about the FDA getting more conservative since the Seven Plus, in that IT was not labeled with regard to single or multiple patient use, and has exactly the same sensor/transmitter/receiver design. They clearly have concerns now that they did not have before, if not about this design, then perhaps appearances.
A bit of a shame “cooties” have become an issue, though. The transmitter is small enough it can be immersed in alcohol or any other disinfectant, and may even survive an autoclave. Handling a receiver someone else has used comes down to dealing with others, however, since there isn’t even body contact. There are cultures, of course, that don’t shake hands, so that can be important. You’d think the FDA would let such folk decide for themselves about the receiver, though, and allow the transmitter to be sterilized. Oh well.
Dexcom shipped me a replacement 7+ on August 24, 2012, and now wants $399 to upgrade. At that time I asked about the new system and was told they couldn’t discuss it. Since it was a replacement I was not in any hurry to get it and would have waited.
They rushed to unload an old system on a loyal customer and for 7 days they want $399. Too bad . When my Dexcom sensors run out I’ll go back to Medtronic.