Replies to This Discussion

Permalink Reply by metheniac on February 1, 2013 at 9:00pm

Thanks for posting this. I wonder how long it will take the FDA to approve.

Permalink Reply by Andy on February 1, 2013 at 9:03pm

He didn't actually do anything with the phone though, so there's a chance that it's just an image and not a working system yet. I wouldn't be surprised if a CEO did that to help the brand. As for FDA approval, expect it to come out "really soon" aka 2020. :/

Permalink Reply by NatalieHodge on February 2, 2013 at 5:02am

Oh Crap! I saw that too! It looks like an android phone! I think it is real. They are wiping android phones, ( FDA requirement for med device) and putting just their software on it. Now whether this is an actual device that will go on market is ??? they have also said their next device will be combo with pods, so??? I did talk to artificial pancreas researchers at UVA and they are seeing this same data withisimiliar user interface on an android phone in their research, and they are doing studies for AP for age 12 and up. The extra feature is a " green light" for the device to be functioning and working. Cool stuff!!

Permalink Reply by Andy on February 2, 2013 at 3:01pm

Why would it have to be wiped? That kind of defeats the purpose, otherwise people would need be carrying around two smartphones if they want to use one as a phone.

Permalink Reply by NatalieHodge on February 2, 2013 at 7:54pm

That is mandated by FDA, has to do with it being a medical device...

Permalink Reply by Doug on February 2, 2013 at 7:59pm

And that is fine for the testing phase BUT they need to find a way to allow it to be added as an APP on working phones. Its not as if the app is making changes to insulin delivery. Its just a display.

Permalink Reply by Joe White on February 6, 2013 at 8:51am

Maybe the FDA needs to be educated on todays modern consumer devices, that are perfectly fine to display information

Permalink Reply by TheTurtleMoves on February 6, 2013 at 4:44pm

If it's going to be displaying medically-actionable information it needs to be completely reliable.

That means no installing other apps that can make the phone unstable and interfere with the reliability of the DexCom app. Unfortunately, with the android being so easily customized by anybody and their monkey's uncle, that means locking it down to prevent that.

Maybe it could retain default phone function though. *fingers crossed*

Permalink Reply by Doug on February 6, 2013 at 7:18pm

Turtle
You are missing the idea that according to the FDA the dexcom is NOT medically actionable ... Period
You are not supposed to act on ANY number except finger sticks

Permalink Reply by Andy on February 6, 2013 at 8:36pm

And if a smartphone Dexcom app failed for any reason, it wouldn't affect the user, because we should still be relying on finger sticks. I could see the worry if a Dexcom app was actually sending information like how much to bolus, but it doesn't - it just shows a number with no action.

Permalink Reply by Doug on February 7, 2013 at 5:38am

Exactly - The FDA needs to pick one side of the argument or the other. Either its a critical medical device that should be actionable or its a pretty trend graph. At this point they assume its a pretty trend graph. So there is no reason not to allow it to be displayed on my phone, my cars navigation, the corner of my big screen TV, and the corner of my PC. If the manufacturers would just agree on an open interface it could be that easy since pumps and CGMS systems are similar 4 or 5 button interfaces with a display.

Permalink Reply by Joe White on February 6, 2013 at 8:48am

It is an Android phone, because Android lets you decide if you want to install apps from 'Unknown Sources', like Amazon Appstore, or the app developers website, etc. You can also install apps from the SD Card. Apple only allows app instalation only from their approved list. It doesn't look like they wiped the phone, the signal strength, battery level and clock are still on the screen, and they are from Android, not the app. It is just a demo on a non-diabetic, therefore FDA approval is currently not required yet, probably not even submitted to them yet.

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