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Dexcom G4 Platinum APPROVED!

Pretty colors ...I've been using a Dexcom for the last five years, and I'm absolutely thrilled to see that the new Dexcom G4 Platinum sensor has been APPROVED by the FDA.  (Yes, you just saw "approved" and "FDA" in the same sentence.) 

According to the press release:

"Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

'Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view,” said Terrance H. Gregg, Dexcom CEO. “The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance.'"

As far as what's new/updated, here's a snapshot:

YES

"The Dexcom G4 PLATINUM offers not only outstanding accuracy and performance, but many new capabilities, including:

  •     Longest transmission range, enabling improved patient flexibility and convenience
  •     A smaller, discrete profile that fits busy lifestyles
  •     A first-of-its-kind color LCD display for easy viewing
  •     Customizable alerts with specific tones
  •     'Hypo alert' setting at 55 mg/dl that provides an increased level of safety — a feature that no other device has."

I'll be updating this post with images and information later in the day, but for now, I'm having a celebratory cup of coffee and really, really looking forward to the new G4 sensor being part of my diabetes management plan.

Update:  Here's a video introduction to the new G4.  

Comments

BAMthereitis! Can't wait. Up for a new Dex in January. Hopefully it will be available then.

Yay I am so excited!! Thanks for the information. We are ordering my daughter the One Touch Ping tomorrow and we were looking into getting the Dexcom as well. I definitely will have to check this out more

Yay! Wow!

Anyone else looking forward to saying 'Rolling in my G4, hommie'? Or is that just me/

SO exciting! Does anyone know what this means for the Animas Vibe? I've always heard that the holdup was getting the new Dexcom approved.

It looks like an iPod!

Whoop whoop awesome news for a Monday. My DD just said she is going to be feeling so fly like a G4!!! Like a G4! Can't wait!!

Finally! I love new robotics! Now get that new Omni Pod out... I have been promised smaller for rhe last three years...artifical pancrease NEXT !!!

Carlyn

It means the Vibe is going into to the FDA soon if it is not already in. Dexcom has spoken about it in their earnings calls. Vibe FDA application timing was dependent on G4 approval. So with G4 approved Vibe application can proceed.

http://www.ydmv.net/2012/08/kind-words-for-fda-dexcom-earning-call.html

So jealous that I have to wait until next summer for a new one!!!

Woooooo hoooooo!!! Can't wait for the Vibe...even though that receiver looks pretty sexy!

Just called Dexcom and they are set to be shipped the last week in October.

I'm not out of warranty until December but can pay a $399 upgrade fee to do it now.

Not sure what I'm going to do but very pumped for the G4!!!

Want, want, want, want.....

Awesome!!!!!!! Up for a new DexCom in June 2013. Who ever thought I'd say, "can't wait!"

Dexcom solicited me two weeks ago to renew my Seven Plus and it arrived last week. I just called them asking to exchange the unused Seven Plus for the new G4. They said I will have to pay a $400 upgrade fee...whereas had I just waited two weeks, this would be covered by my insurance. Unfortunately, this is my third shady dealing with Dexcom in our year long relationship. [Strikes one and two involved the definition of "full refund" and whether the Dexcom was FDA-approved for use during pregnancy (that half-truth came from a local Dexcom trainer in multiple emails to me...doubt Dexcom would like that liability)]. I imagine these comments won't make it on your blog but I've tried to work these things out with Dexcom and the only result is that I get routed to different people who have no power to do anything other than sell me more Dexcom stuff.

Need to post an update: I called Dexcom back, got a different CSR, and she looked up my account and told me I am eligible for a free upgrade that will ship in December. I am happy with this news and happy with the product...but not sure why I got two totally different responses on this.

When I heard that news this morning, I thought, "This is so much bigger and cooler than the iPhone 5 release." I am a diabetic nerd.

INTEGRATION!!!!

...

What, too soon?

As Bennet said, this was the step we were waiting for. Hopefully now the Vibe can make it through the FDA quickly.

just 8 weeks til I'm eligible... guess I will skip paying upgrade and wait. Sigh. Now if my tSlim would just show up....

Heck yeah!

WAHOO!!!!!!!!! We've had a great relationship with Dexcom, and I'm thrilled to hear this awesome news!!!!!!

Maybe *this* will encourage my girl to wear her Dex more; she really, really dislikes the current system. Teenagers... :)

I'm waiting for the Vibe also.....I like the Dexcom info, just am really tired of carrying around all these devices..... :-)

Fantastic news! I got a new Seven Plus a few months ago, but will probably start saving my pennies for the upgrade.

My MM pump just went out of warranty and I wonder how long it will be for the Vibe to be released. I also wonder if you purchase the Gen4 system from Dex, will the transmitter be the same for the Vibe so that you don't have to buy that again?

To Allison: Someone quoted this at Insulin-Pumpers.org. I don't know where they got the info, but don't give up hope yet.

" Anyone who shipped Sept 1 - Oct. 5 will be able to upgrade to the new G4
Platinum at no charge.
Anyone still in warranty will be able to upgrade for $399.00. "

Does anyone know yet if the sensors will cost the same or did they increase the cost?

Thanks, Laddie. The first CSR I spoke with didn't take my name or look up my account - he just went straight into the $399 discussion even though I told him I got my new Seven Plus last week. When I called back to see what the rules would be about the $399 upgrade (i.e. deadline, etc), that CSR actually looked up my account and told me I was eligible for the free upgrade. Like I said earlier, I like their product but I have a really hard time getting good information from their people.

Did that guy at the 1:06 mark in the video just correct based on his CGM? I am so tempted to defect from Medtronic and get this. So tempted...

Wow! That looks so cool. Too bad I just got the Dexcom 7 last Spring so I'm in the $399 for an upgrade bracket... If I didn't have to pay for a little one on the way I'd totally get it! Holding out for the Vibe I guess...

I just received my new Seven Plus on Wednesday of last week (I've fought for three years to get it). So it goes without saying that I'm not happy that no one told me about this being a possibility! And I just told DexCom so via email. If there is a way to get the free upgrade that Laddie spoke of, I WILL find it and leave you an update. Wish me luck...

Will the new Dexcom software work with a Mac? I currently have one but can only use it to read real-time numbers and not for analysis.

Scott.....one should never correct or dose based on a CgM reading.....I was thinking the same thing when I saw the video and how that shouldn't have been in the video.

Okay, I got an email back from DexCom almost immediately. Here is the important excerpt;
"I understand how frustrating that must have been to see that the new device is now out. But don’t worry we will take care of you. Since you just purchased in September you will be eligible to upgrade to our new system at no charge. " Great company. Looks like I'll be sporting the new model soon!
To anyone in the same situation, just shoot an email over to the customer service address listed on their website. I got my reply in minutes.

I used one of these at camp for a study. I love them... I really want a pink one to match my ping... (They mise well match my pump warranty lasts almost 4 years still... ) Did I mention I need this thing? It's going to be my new love, I swear :D

Yay!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Yay and darn!! I just got my Dex 7+ in Sept. but they say they shipped on Aug. 13 (which meant it was weeks in transit), so I will have to pay the $399 upgrade fee. But what the hey, I can't take it with me, so I'm going to go for it; my warranty wouldn't be up until next Aug. and I don't want to wait that long!

I just got trained on 7+ for my 5 year old son on September 18th. Frustrating that I asked our rep about upgrade and her response was that the only upgrade will be in combination with Animas. Just using second sensor, and listened to my kindergartener complain this morning how he has to carry too much stuff.

While it is always exciting to see new devices come out (and I admit that I love the new factor), I am extremely disappointed by what I see in the new Dexcom: The improved accuracy is needed, but so, too, is a smaller receiver and the ability to modify their hard-wired low alert.

They tout that they are the only cgm with such a hard wired alert as though that's a good thing. In fact, their hard wired alerts are an impediment to better patient care as they increase the number of alarms. If I set a low alarm for 70 and have a Dexcom-perceived blood sugar of 50, I don't want to have another alarm go off because I'm below 55 as well. Ultimately this means that I don't set a low alarm because having too many alarms drives me bonkers. Dexcom would be better for my use without their hard wired alarm. Why do they think they know what is best for everyone?

As for the receiver size, it has much dead space. It needs to be smaller and not require charging. End of story. Anything less is a large design error. Requiring charging of medical devices limits their utility by people who don't simply work within boxes. How do you travel internationally to remote areas with a receiver that has to be charged? Where do you stash a large receiver when running in addition to gu?

In short, while I appreciate that Dexcom's sensor is the least painful and most accurate I've tried, I continue to be dismayed by their inability to actually make a decent product. I am also concerned by how blindly the DOC becomes elated. Start demanding better products! Don't simply provide kudos because it's new and shiny.

While the argument can be made that the increased accuracy is all that matters, it isn't. The platform is equally important. Diabetes is a disease of information and how to utilize it. More seamless integration of technology is equally important. If I can't fit the receiver into the pocket in my pants, it isn't with me and thus, isn't receiving information to help me manage my diabetes. If I can't plug it into a wall outlet, it doesn't have power and can't be used. These large design flaws are impediments to Dexcom's use and, therefore, its ability to have a positive influence on diabetes management.

when will it be ANT+ compatible so it can communicate with ANT+ watches/cyclometers/gps and thus have your BG on your wrist/handlebar???

Just talked to a Dexcom rep last night... pink G4 will be sent out to me at the end of October!

OHMYGOD I swear I will die of anxiety waiting for the G4 to show up at my doorstep!

Does anyone know how long a Dex is under warranty for? I've had mine almost a year - but would obviously love to upgrade!

One year warranty! I called today. We are eligible in December, but they took my order today. Nice!

Not sure if anyone will see this or respond since the post is a few days old but with all our dealings lately with finances and a school resistant to a 504 I haven't been able to keep up on anything else lately.

After one year with a dexcom you are eligible to get a new one through your insurance? It seems like such a short time when the pump has a four year life. DD just busted her dexcom by slinging her back around (according to the school nurse she's rather violent with that thing) and I had to pay $200 to replace the unit. I don't think we would be in the market until next year when the FSA starts over. But the year is up in May so maybe we'll just wait?

Also, I don't know a lot about the Vibe. Will that be compatible so you only need one device? Since everyone is excited for the vibe now that's the "vibe" I'm getting :-D Do you think animas will offer an upgrade program? I would be willing to budget for that if people thought it would happen next year and replace them both.

Thanks to anyone that's able to answer.

1. to Scott E., I always correct based on my Seven Plus, and only occasionally have to check with my meter.
2. to Valerie, no Mac software. I cannot understand why Dexcom ignores 25% of the population and requires us to use Parallels or some other questionable Windows program on OSX.
Also, my information is there is still no car charger available, and the unit will will not charge from a USB port or Apple car charger due to the cable design.
It is still better than anything else, however.

Update on my previous post:
Dexcom CS tells me the G4 WILL be able to charge from a computer AND from any USB charger, such as that for an iPod/Pad/Phone. The means it will also charge from any one of the number of battery backups available for the iPhone (I have Richard Solo external batteries) and that will make a big difference to me on long trips away from electric power. I now charge my 7 Plus from a 12v to 110v inverter in my car.
Caveat, the transmitter battery will go out of warranty now after 6 months (instead of one year for the 7 Plus), because of the additional power required for the extended range - the need for which escapes me.

I was so happy when I found out that dexcom g 4 would be shipped on oct 29. STOP. There's a catch. Only new customers will be able to get the new g4 which cost around $1200. But us old customers will have to wait wait. . Don't get me wrong. I love the dexcom seven plus. But am almost out of sensors. I came to realize something. "Money talks". So if I pay the $1200 now I can get the new g4 but if I can only afford to pay the $399 upgrade then ill have to wait. Whatever happened to rewarding old reliable customers. I gues it comes down to money money. That's so sad. Dexcom saved my life years ago so all I can say to them is shame on you

The Oct 29th date is for new and loyal out of warranty users. Then in November/December hit those with FREE and other upgrades.

I can't wait for the Animas Vibe. My Norwegian wife already has one. I know how to drive it. So, it is RSN (Real Soon Now). And the G4 Platinum is very enticing. P.S. I have spina bifida and spasticity and my T1 diabetes so I was hypo unaware from my DX.

Has anybody in the US received any information regarding the game-plan when the vibe comes out? The G4 looks great, but as a pump user I'm hesitant to upgrade before hearing any word on the vibe. I'm guessing the Vibe would be purchased through animas, rather than dexcom, so I imagine there is no chance of a discounted upgrade once the vibe hits the shelves..

Can people who take acetaminophen use this sensor? I couldnt use the last one because of problems with the sensor being affected by my pain med with tylenol. Gosh I hope so....

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