Anyone heard anything new about when the two will be integrated?
I’ve spoke to both a Clinician for Animas, and a regional Rep for Dexcom. Unfortunately It is still in the process of development and testing stage. There is no ETA. the rep for Dexcom says, if anything, it will not be for another couple of years unfortunately.
They are still waiting for FDA approval and of course they need to be sure it works correctly, etc
They Dexcom had a problem with the sensor wire for the Gen4 sensor .It didn’t work well with kids & the wire would get stuck inside of you when the sensor was removed.
Yikes!
Wow… After reading what you’ve just said, maybe I should wait about a year AFTER it comes out, to see how well it does. I hope it will it will work with only one insertion, instead of two…
That is the hold up trust me they will not release it if its not safe for child I think over 10yrs. We have people here that have trouble with using insets I did too . So don’t be scared off . They are still doing testing.
I think it will be sooner than 2 years. I suspect it will be at the end of 2011. The problem with releasing the integrated system has more to do with the FDA than any problems with the Dexcom sensor. While it is true that Dexcom previously had problems with the sensor breaking off in a few patients this has not been an issue with the new sensor. The FDA decided that any type of infusion system would require more in-depth review than ever before, thus the hold up. Previously a pump manufactuer could file for a new pump under the 501k process that basically allowed the pump manufactuers to build on a previous platform, with minor modifications (think of the difference between the Animas 2020 pump and the Ping- basically the integrated glucometer you can bolus from with the Ping). Now the pump manufactuers are required to submit much more information to the FDA to get a new pump approved even if it is basically the same thing they have released before. This is new ground for ALL the pump manufactuers and all of them are not quite sure exactly what then FDA wants or what this will entail. Because of this delay Animas has decided that they will release the integrated system with the NEXT sensor Dexcom will release. I am willing to bet Europe will see the integrated system before the USA because their version of the FDA is not requiring the same thing. Hold tight because I think in the end it will all around be a better product. Although I guessed at a timeline of when the product would be out anyone who is guessing, be it an Animas or a Dexcom employee or not, is basically doing just that- guessing. This whole buisness with the FDA is uncharted territory.
For more information you can listen to the DexCom, Inc. Third Quarter 2010 Earnings Conference Call at
http://investor.shareholder.com/dexcom/events.cfm