I agree that the demo might have been faked. He claimed that eating oatmeal had caused an up arrow an hour previously when clearly it had been quite flat and had not gone over 150 in the previous 3 hours.
Yes, he's not diabetic so you wouldn't see a peak. Why did he claim he had an up arrow an hour earlier?
non diabetic wil still see a slight increase - which is shown on the graph - and when the BG is going up the arrow would show UP as he said
My Endo doesn't seem to think this would ever happen. He says phone companies do not want the responsibility of something medical like this.
Will be interesting to see what happens with this in the future, either way!
Fear of liability is crazy. The fault would be on the user, or possibly Dexcom if there was a real problem with their system, but in theory this crazy long FDA approval process is to ensure that that can't happen. The phone can malfunction too, but isn't going to give you wrong numbers. It could only not accept a signal or not be able to run the program, which would not be a major medical catastrophe especially since Dexcom and other CGMs make it clear that you still need to rely on blood sugar readings and not CGM alone.
Thats the part I dont get - why does the FDA care at this point ?As far as they are concerned this is used for trends ONLY and no treatment is EVER to be done based on its results.
the numbers cloud be displayed on an etch a sketch .... with the current rules there is no liability
I agree with this completely. I'm happy with Dexcom's direction and I'd be perfectly willing to sign some sort of waiver saying that I won't sue anyone if my phone crashes or gives the wrong reading.
When I first got my DexCom Seven Plus I compiled a list of things I wanted to see changed with both the hardware and software. Some of those changes are already in the G4 (smaller size, better shape, micro USB port). Other items on my list will hopefully be addressed in future versions. Using a smartphone instead of a proprietary receiver was high on my list and I'm glad Dexcom seems to think so as well.
The current Dexcom implementation uses proprietary software in the receiver to calculate a glucose reading based on transmitted sensor values after filtering out noise and integrating calibration values.
Since a phone implementation would necessarily use Bluetooth for connectivity that is by design two way communication instead of the current Dexcom technology of a transmitter than only transmits and a receiver that only receives. This would open up the possibility of adding the calculation logic to the transmitter itself. The calibration values would be sent to the device and it would return the calculated glucose. You could then have non-proprietary receivers that would only display the value without the risk of faulty calculation logic; wouldn't it be cool to have a Bluetooth DexCom watch that always shows a reading? I hate having to press a button to see the value - especially since doing so also snoozes any alert. Another possibility would then be to integrate the calibration process within meters. It would be nice to not have to manually enter values when they could be transmitted from a meter automatically.
Good feature ideas Mike. I think for pumpers, the smartphone capability is somewhat of a null point. I don't currently carry a smartphone on me, but I of course carry a pump with me all the time. When I'm able to have a Tandem or Animas that links, I'd prefer that to link rather than an otherwise uninvolved smartphone.
The FDA approval process doesn't work with waivers though. Their purpose is to make sure things can't crash, not deal with potential law suits when they DO crash. Though this should be another moot point until they start approving devices that automatically test and administer insulin without human input.