Amazing improvement in accuracy Dexcom has been able to achieve an outstanding MARD of 9% (fingersticks=5.6%) via an improved G4 algorithm. This improved algorithm may get get pushed out to current G4 users but I'm guessing this will be a G5 thing. With improved accuracy, Dexcom really believes they can someday achieve FDA approval as a finger-stick replacement and this in turn will leverage future coverage of CGM under medicare.
G5 They hope to submit their G5 to the FDA by year end. The G5 will beam readings via bluetooth and initially it will work with the iPhone. The mobile app faces the full Class III regulatory pathway but not the device that would run it, i.e. the iPhone, other smartphones, even a smart watch will not require FDA approvals. Very cool, this means that within the next 2-3 years most if not all smartphones will be able to display CGM as soon as Dexcom develops the mobile app for all of the smartphone OS. I'm guessing Android will be next to follow iPhone, and then Windows (Blackberry works with Android apps).
Pharmacy Coverage They made some encouraging comments about increasing coverage of sensors as pharmacy versus DME. This could be a game-changer for folks like me for whom cost is knocking Dexcom out of the picture. "...we are moving rapidly. And so, there's -- a good number of patients are getting processed that way. And contracts are falling into line the way we want them to...any patient that comes in here, we ping -- we call it ping, we ping their pharmacy benefit first. If we can get them product through the pharmacy at a lower co-pay, we run with it."
Dexcom rocks! They keep working to improve their product and it never ends.
Considering the iPhone's iOS 8 has a medical app built in with connectivity to a LOT of upcoming medical devices, the regulatory part may be easy. (fingers crossed...)
I wonder if G5 roll-out is influencing the much delayed introduction of the Animas Vibe into the US. If the Vibe is approved in the US and then Dexcom introduces the G5 within months of that, there will be many unhappy Vibe users in the US. Unless, of course, the US Vibe is forward compatible with the G5.
Vibe was submitted for FDA approval last year. So most likely it has G4 radio-link (as in Europe) not bluetooth (as required by G5).
And remember; "Gen 5 from a sensor perspective will be a Gen 4 PLATINUM sensor built on the same manufacturing line with the same membranes."
(So only difference between gen4 and gen5 is the transmitter...)
That is not correct. The upcoming G5 will still use the same G4 sensor design but the new transmitter will have new algorithms which will help it be more accurate and should cause less ??? readings.
I agree with Anthony, each new generation improves on the algorithms. Plus Dexcom says they will still offer external receivers for those without smartphones or who want one so you can compare features of Bluetooth vs RF. Once Gen 5 is released they should have specs which compares Gen 4 and 5 and you can decide whether or not to upgrade.
A lot would depend on how long after the release of Gen 5 they support Gen 4 receivers. If the Vibe is approved then they will be making Sensors and transmitters for the Gen 4 for a long time yet to come since pumps have a 4 year warranty. That is assuming the Vibe is Gen 4 RF only which would be my guess. I don’t see any way that Animas can submit for Gen 5 compatible Vibe pump until Dexcom has released the Gen 5. Although it would be stupid of them not to have a Bluetooth pump currently in development since that’s the direction Dexcom is going.
