A lot of interesting tidbits in the transcript .
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.
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).
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...)
Just had this thought... "Hey Siri! What's my Blood Glucose at?" :)
Thanks for sharing this, Don. Encouraging news indeed.
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).
"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...)
Sounds like if one doesn't use IPhones or some other high tech thing he will receive no benefit from the coming G5
Am I correct?
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.