FDA Clears First Smartphone App For Insulin Delivery (theverge.com) 13
The Food and Drug Administration cleared a smartphone app from Tandem Diabetes Care to program insulin delivery for its t:slim X2 insulin pump, the company announced Wednesday. The Verge reports: It's the first phone app for both iOS and Android to able to deliver insulin, the company said in a statement. Previously, delivery had to be handled through the pump itself. With this update, pump users will be able to program or cancel bolus doses of insulin, which are taken at mealtimes and are crucial in keeping blood glucose levels under control. "Giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution," John Sheridan, president and CEO of Tandem Diabetes Care, said in a statement. [...] Tandem said in the statement that it will launch the new bolus delivery update for select users this spring ahead of a wider launch this summer.
They've been moving that way for a while (Score:3)
My wife's latest Omnipod pump comes with a controller which, if you were to dismantle it, would likely turn out to be an off-the-shelf unbranded smartphone running a customized Android. Presumably this device is a stopgap until that app gets approval.
Re: (Score:3)
My wife's latest Omnipod pump comes with a controller which, if you were to dismantle it, would likely turn out to be an off-the-shelf unbranded smartphone running a customized Android. Presumably this device is a stopgap until that app gets approval.
I'm just guessing that your wife is using the dash model? I just got hooked up today. The off brand android model is called a PDM, and it has all of the cell phone bits turned off. To my knowledge, the us gov't didn't originally allow insulin delivery via smart phone until today - thus the cheap android/pdm device. There is an omnipod model 5 coming out is the very near future - it's my understanding that it should talk to smart phones then.
Re: (Score:3)
Yup. Switched sometime last year.
Yeah, the communications are all BLE. I have to hand it to them, using a custom smartphone for the PDM is a really nice touch, and a smart transition move.
An improvement... (Score:3)
But I'll give it a try because I agree that putting in meal bolus is the most common interaction with the pump.
Interesting typo in the article:
The change could be a big improvement for people who prefer not to have pumps out in pubic settings or attach them to undergarments like bras.
Re: (Score:2)
Interesting typo in the article:
The change could be a big improvement for people who prefer not to have pumps out in pubic settings or attach them to undergarments like bras.
Common mistake really, it’s understandable considering most people don’t understand the pubic insulin pump scene, nor know for that matter how large and lucrative it really is.
what could go wrong... (Score:1)
controlling insulin using an internet-connected device....
My diabetic wife's reaction (Score:3)
"I've been waiting for this."
Of course, it's currently only useable with a small number of phones... I imagine that should broaden out quickly, but who knows with the FDA (not to mention companies like Tandem are probably somewhat resistant, but facing overwhelming consumer demand).
apple will want 30% of the drugs and the aca will (Score:2)
apple will want 30% of the drugs and the aca will say no to that level of cut.
terrifying (Score:3)
You think the FDA does some kind of quality control on these kinds of devices, but I've seen otherwise.
For example, those Continuous Glucose Monitors that you stick in your arm and use over blietooth on your smartphone. The device announces "HIGH GLUCOSE", whether the reading is high or low. So someone hears it announce "HIGH GLUCOSE", and the decide they need a does of insulin or to take metformin or whatever. This could easily KILL the person within minutes, if they believed what the device said and acted upon it.
This bug was reported to the manufacturer years ago. They don't care and don't maintain their software. I've talked to their developers. They also don't need any FDA approval to randomly update the software.
So now you tell me that there's going to be an app on the phone that will actually control the insulin pump, with no human intervention.
First, I don't think the FDA is competent to approve such an app.
Second, I don't think the FDA is going to prove competent to evaluate the security of the app.
I think people are going to get hacked, either at the bluetooth controller, or at the app level.
I expect you will soon be able to kill a human being by merely sending them a text message. This will be done by foreign agents as assassination. But it will first be done and perfected by some 14 year old kid who is mad at someone. Or by a 19 year old kid just for the lolz.
Re: (Score:2)
Re: (Score:2)
Re: (Score:2)
The bug has been there for years in "Freestyle Libre 14 Day".