Possible updated Dexcom sensor in clinical trials


Does anyone know when the new Dex is expected to be available?

Given that the document talks about a trail last April, my bet is that right now not even Dexcom knows for sure when G4 will come to market!

Ciao, Luca

old news- the study was COMPLETED in April, having started in February. I just did a long post to a related discussion, “Tell Animas/Dexcom to get on the Ball”, here: http://www.tudiabetes.org/xn/detail/583967:Comment:1161909

Most of that post talks about this issue. G4 isn’t even in PMA, yet, although I think that the application was probably submitted in May. It looks to me like the relevant FDA tracking number is probably P050012/S023. (i.e., supplement number 023 for changes to the original Dexcom device.) That’s the FDA announcement to watch for… or, of course, just keep your eye on Dexcom’s own announcements.

I just listened in on the DexCom Second Quarter 2010 Earnings Conference Call. DexCom has filed a PMA for the Gen4 sensor. The Gen4 highlights are: 1 hour startup, improved accuracy. DexCom might file a PMA later to reduce the requirement for calibrations. Gen5 is in the works with the goal of drastically reducing or eliminating calibrations. The Gen5 transmitter will be able to connect to a host of devices, including pumps and smart phones.

I’m waiting for the integration between OmniPod and Dex!

I understand it is in new OPs but must be turned on by a “firmware” upgrade that has not been released. I believe it will work via the OP remote.

Well usually a few months after the trials one usually sees a 501k PMA, esp if they can prove its equavalence to the prior product… Just found it in there when i was looking for some news on the Spirit Combo…

Guess Helmet heard what I predicted during the second quarter conf call… :wink:

I’m with Jay on this “guess”- it sounds like OP and Animas have both already finished their programming, but are left in waiting mode on the Dexcom Approval. OP has to be via the remote – the Pod itself has no display screen. But, assuming that the antenna frequencies in the Gen4-based products are still “pinned”, J&J could have done any of 3 different things:

#1: The ping remote could be re-released with software which supports Dexcom ONLY. You would choose between running your Ping pump from the pump’s own menu/display or wearing two Ping remotes. This would be kinda sucky, but at least you’d have replaceable batteries.

#2: New Pump and Remote, both supporting two-way communications with Dexcom AND EACH OTHER at Dexcom’s native frequency. (This is a nice alternative to use, but you’d have to buy a new pump and pump remote. I think that this is what they’ve done.)

#3: New software in the pump and remote, which J&J could perhaps offer as a cheaper upgrade than entirely new devices containing new antenna hardware. They’d run at the current Animas frequency, on the current antennas – and Animas would contract with Dexcom to have special transmitters built for Animas to sell to their “integrated Dexcom” customers. Best for us, but I’m nearly certain that it WASN’T done this way.

Yes, May was within the second quarter. I checked the database for Dexcom’s 2010 PMA’s, and saw that “S023” is the missing number. All of the others, through “S024”, have been awarded approval. S024, a change to improve consistency in the characteristics of 7-plus Sensors within manufacturing, went through on June 9.

I’ll SWAG that Gen5, for which I’ve not seen a description before your post, involves a Transmitter which can change frequencies in order to support all these devices. And I’ll further SWAG that it will be done via Bluetooth. Thanks for the post!! I’m sure a lot of people still hope for a single-frequency implementation, based on Gen4 with pumps from the long-ago announced partner firms. For them, another year of waiting would really suck!

One thing I have heard from a rep is that the pumps screen is used for the Dex, not the remote… so why would you use a remote as a transverter… You cant assume people will always have the remote in range…

Tending to think 2 or 3 is the actual option. Hopefully the CGM doesnt break the remote functionality like another pump vendor…(you can either use the meter as a remote or the CGM, not both)