Dexcom Gen 4 predicted FDA approval in US by end of 2012 (now available in Europe)

It sounds like after you get the dexcom the customer service is good. I hear a lot of good things about dexcom; but there are other companies out there that are claiming to have better accuracy and yet the FDA want approve any of them. sometimes i wonder if some of the companies are buying off the FDA so some of the other products want hit the market. Good thing the FDA is looking out for us.

I do wish these companies would stop with the constant 'predicted' release dates. I think Omnipod has been releasing their new smaller pods since 2007, and the same with the Animas Vibe. I feel like they just pull you along by a string constantly. That said, when the Dex4 comes out, I'll certainly be interested. I have been "Dexing" for 2 1/2 years and have been very pleased with the comfort and reliability of their sensors. However, I do wish it was integrated with my pump, I don't like carrying two devices. I have the Minimed 522, which I do really like. Do you go with Animas and hope the Dex will eventually come out integrated with them....or stick with minimed which at the very least, already has that option and will simply be improving on it with their Enlite sensors. Don't know, time will tell.

I already have the animas ping that I am very happy with. The sales rep said it would be a $99.00 upgrade charge to get the vibe. But that was a year ago and who knows if that still stands. I'm not sure if I want the vibe because then you have to give up the remote bolus feature. When they come out with the dex4 will it be compatible with the vibe?

I have heard different things, so don't completely quote me on this. My understanding is the Vibe is waiting for the Dex4 Approval as that is the sensor they are submitting with the Vibe. So I believe the Vibe will come with the new Dex4 sensors. Right now, I do put my pump in some difficult areas at times, where I can see how a remote would be helpful to bolus from. However, if I went with an 'integrated' set up, I would have my pump in an easy to grab area all the time (to check, and to correct the never ending alarms LOL), so I wouldn't care so much about the lack of the remote. However, I have heard quite a few Animas users express the same concern in regards to the Animas Vibe and the lack of the remote bolusing. Truthfully, I am really interested in the Enlite Sensors, and wish they were released in the US already. I'd love to try them.

talked to a MM rep today after she helped me with a new ( to me) insertion of a MIO infusion set. We chatted and she said not to hold her to it, but that Medtronic Mimimed is pushing to get the Enlite sensors avilable in the US by the end of this year(2012). I really hope so!!

God bless
Brunetta

Danielle (and many others) - I understand the appeal of reducing the number of devices that you must carry every day.

What I don't understand is a tubed pump/CGM combo beep-beep-beeping a low alarm that you don't hear because it's buried under the covers while you sleep. I highly value night-time low alarms.

Preventing sustained overnight lows prevents sustained rebound highs the next morning. Pump/CGM integration without a remote is a non-starter for me.

Agree: nowadays it wouldn't be difficult to manifacture e slim remote with pump and CGM display which you clip to your tubed pump, if you want and prefer only one whole "brick" ;-)

That's one creative work-around garidan.

One that I think is more likely is the integration of the CGM function with the existing OmniPod PDM remote.

I feel like many in the pump-wearing CGM-interested community here has not thought this integration issue through. And some manufacturers seem to be following Medtronic's lead as it will reduce their costs.

Enormous failure of the last four years? Thanks, tea party. You caused it. The unwillingness of Congress to get anything done at all has been an embarrassment to the world.

Terry, I can certainly understand that. I guess, for me, I have missed my Dex alarms as is at night. Now the Mysentry(although, I hear it is out the ying yang in regards to pricing) sounds interesting for night time protection. Now that would be something I would think of in regards to their pump/integrated system. On another note though, I just had my hands on the Roche Accu Check Combo pump(FDA just cleared it July 18th), and wow...I might jump ship from all the current pumps and go to that one when my warranty is up here shortly...and just keep my Dexcom as is(seperate unit). It has a seperate remote(like Animas), but you can do EVERYTHING off of the remote. Change basal rates, bolus, review pump settings. It is like your pump...without having to actually grab your pump. It is also color screen(remote), which is nice, too. But that is a whole different topic, sorry for going off track LOL!

that sounds grand, wish it had a cgm. Is it described, photographed on their site? I thibk I will go check it out.

Thanks Danielle
God Bless
Brunetta

Ultimately the CGM (and pump) will be integrated with your smart phone. There are a couple of technical issues predominantly around the power required to interface to a smart phone. The proprietary wireless interfaces for CGMs and pumps draw much less power than even the new Bluetooth 4 standard (which is on very few phones today).

The other issue is the mobile "app" is not a very controlled environment so it would be difficult to get it through the FDA. I'd love to have the ability to slice and dice all the data from my pump/CGM through an app on my phone someday...

Brunetta, From the short time I had to play with it yesterday...yes it is very much like the site described. The remote itself also felt VERY sturdy(not cheap and flimsy), too. I really quite like it, and can't wait to try it early next year. I think a lot of potential users of Animas will taking a closer look at this pump because of the wireless remote. I will say, if the integrated CGMS ends up being less of a deal to me...I am feeling very swayed at the moment towards the new Combo pump.

If you have an opportunity to have a rep show you the pump, I would certainly take a look at it!! :-)

Dannielle, I went to the website and sent a letter asking for a rep to show it to me. I gto a prompt email response today, saying that they have not "launched" the models and that they would get back with me after that event had ocurred. I was told to go to the Roche/Accu chek website to get more information ( which, incidentally is exactly where I went to to get the "contact us form" AFTER perusal of the Spirit and Aviva pumo combo)s. My supposition is that they do not have rep for Columbus , Ohio or do not intend to market it here as soon as in your area. Where do you live?

God bless,
Brunetta

I would be surprised if you did not have a Rep in your area. According to the CDE and Rep that was showing off the pump, the FDA approval came as a bit of a 'surprise', and they are NOT quite ready to actually promote it. In fact, the brochure they gave me they had to 'edit' themselves(...edit as in, they literally blacked out that it was not FDA approved, and still pending). It's actually kind of funny if you look at the brochure. One of the reps stated that the guy who originally was showing me the pump technically wasn't supposed to as he hadn't received training on it yet. I go to the BDC out here in Denver, Colorado...and she said they will be sending out pumps her shortly for trials.

She explained that Roche did not set money aside this year for trials with the new Combo pump, as they didn't expect it to receive FDA approval this quickly.

Sorry for the long explanation! However, from what I gather they are all kind of in 'scramble' mode to get the pump out there, but very few of the reps have actually received training, and new brochures etc for the product(as obvious by my 'edited' brochure I received).

I have a feeling you are being told their standard reply right now, as they simply haven't trained the reps on the new pump...and they don't have all the items to sell and promote the pump yet.