Gregory's Server
An insulin pump which depends on an app working at all times sounds like something that should not make it through approval ⚡
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35 comments
@djh @faheus @elfrinjo no, it’s a life saver. Closed loop artificial pancreas systems reduce lows and highs. But it’s a recent technology and there are only a few devices with limited configurability - and not all insurance plans cover them. These people trying out open source versions are pioneers. @rc @djh many diabetics hack pumps and apps in this way due to proprietary software and the whole system "retail" being prohibitively expensive. I don't know much about the actual hacking side of it but I am not brave enough to experiment with it myself. I do multiple daily injections to manage my blood sugar - a luddite in the type 1 world! Fortunately the CGM should catch the high blood sugars but it still isn't optimal diabetic treatment!  I'm on an ultralente and a log, which works just fine for me, but even without a pump, recently my Android phone has been disabling the CGM's notifications for Reasons, which, yanno, not so good. I make half jokes about how because I can tell when I'm low while awake, I can't tell so easily when I'm asleep, so I prefer to be higher before I slumber... Mobile phones are not intended to be medical devices. It can be difficult to create a dedicated device. But to run life-critical software on an internet-connected computer where you have little control or knowledge of the inner workings? Was the app actually killed by the phone to save power? Is there a bug that caused the app to be killed? Perhaps the bug is in the app, not the phone?  @djh thats bad product design, but Samsung is to blame as well, they're just bad at doing Android the right way imo.  @djh wouldn't an insulin pump be a class one medical device under FDA regulations? Like.. erm.. wtf?  @djh Android APS is an open source/patient-and-advocate-driven project. So…no approval involved, really. There’s a very long history here that I (pump wearing T1D) don’t know all the details of about unbelievably frustrating FDA/regulatory foot dragging on approving innovations in closed loop pump technology. The most specific early precipitating example was probably European regulators approving the first Medtronic Guardian system something like five+ years before the US did. @djh they’ve basically caught up (and in fact IMO have possibly swung a bit too hard), but it contributed to a trend of T1D-adjacent folks hacking the available technology to DIY their own closed loop pumps. I have the impression that the movement led to embarrassment at the FDA, amping the pressure to figure their shit out when it comes to approving pump software innovations (like official closed loop stuff, which has been an astonishing game changer in T1D management over the last <5 years). @djh (sorry, you didn’t really ask for a walk through recent socio-technical-regulatory history viz a viz type 1 diabetes medical equipment, but I felt like just saying “AAPS is open source” without at least SOME context was only gonna be more confusing…)    It never should have made it past a design review, let alone prototyping, testing, pre-production... @djh somebody doing diy insulin pump control is kinda outside the approval process anyway ... @djh #T1D myself. Of course, and of course this one is a system built from multiple parts with no certification. I actually considered setting up such a system for myself a few years back. It's the uncommon cases that made me back off. @djh /... @djh /... @djh an app is bad enough, but depending on BT working 100% of the time is somehow even worse @djh I'm not too familiar with the diabetes apps on android, but AAPS sounds like one of those DIY (or compile IY) diabetes apps that are not exactly approved by the local medical device approval authority. But people use those anyway because the same QoL improving features they already have are to be released from the insulin pump manufacturer within the next couple of decades :D  |
@djh This is fascinating, I just learned that AAPS is an unlicensed hack to directly connect the glucose sensor to the pump and to control it in realtime. I would have expected that that is the default but apparently it's not.
So: Cool, but a bit dangerous.