So she was merely ahead of her time.
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FDA authorizes first wearable device that monitors ketone and blood sugar levels
31–40 of 255 posts
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#32Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#33Looked after my son who has T1D for now 5 years, checked keytones maybe 20 times. Compared to blood glucose which we check look at every 5 minutes. Maybe this is more for Type 2 or other diabetes, or for people prone to DKA. Or it is for people with a working pancreas who think looking at their blood sugars (and now keytones) tells them something like soothsayers reading tea leaves
Considering that DKA accounts for 160k hospital admissions a year, your lived experience translates poorly to such a flippant dismissal. [0] https://www.cdc.gov/diabetes/about/diabetic-ketoacidosis.htm...
I agree, but there are a lot of factors going on to contribute to that number.
For example, about 20% of that number is because someone is finding out for the first time they have T1D [1].
Insulin costs and monitoring costs are also going to be a pretty big contributing factor. CGMs and finger sticks aren't cheap.
IDK how often it happens that ketoacidosis happens when glucose appears to be fine, I assume it's pretty rare.
[1] https://www.sciencedirect.com/science/article/pii/S016882272...
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#34Does anyone know if something like this is required to be approved by the FDA? Like if someone were to make one for the hobbyist/weight loss market, would that even be legal?
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#35Earlier quoted context omitted.
I also think there's no financial incentive from incumbents to develop something like this. Why would abbott develop something that works "forever" if they can milk people buying new sensors every 10~14 days.
For abbott, no. But what about for Garmin, Apple, Samsung, or Google? Diabetics would snap up a smart watch which does accurate glucose monitoring in a heartbeat.
As a T1 diabetic, can confirm.
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#36Earlier quoted context omitted.
For abbott, no. But what about for Garmin, Apple, Samsung, or Google? Diabetics would snap up a smart watch which does accurate glucose monitoring in a heartbeat.
There is a major IP holder in the space who is asserting their ownership, so even if they could solve the technical challenges, they might not be able to come to market.
> There is a major IP holder in the space who is asserting their ownership,
Is it a secret? Why not name them?
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#37Does anyone know if something like this is required to be approved by the FDA? Like if someone were to make one for the hobbyist/weight loss market, would that even be legal?
Basically yes, take a look at the not for human consumption drug, sorry medicine market.
Was analogs in the 2010s, Obama had to pass the analog act low… now it’s back with peptides and glp 1 which aren’t scheduled but..
Yeah I guess make enough money and then lobby for the benefit of your audience base or for future proscuation
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#38What about all the other wearable sensors like https://www.stelo.com https://www.hellolingo.com
These are the same CGM technologies (Dexcom = Stelo and Lingo = Libre), just aimed at the over the counter "health and fitness" market. This is not verified info, but I would assume these are either A) the exact same device, just with different marketing B) "binned" production runs that did not meet the accuracy threshold for clinical/prescribed use, but are otherwise "good enough" for someone looking to healthmaxx.
I can all but guarantee you they are the same device. IDK if they are even binned differently. The software is the main difference.
The "real" device gives you what it measures as your real highs and lows while the OTC devices won't report high highs or low lows.
I have a Stelo (I was curious and diabetes runs in my family) while my wife has the Dexcom.
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#39Automated glucose control will be the next frontier in so many areas of healthcare. I'm still skeptical that anyone will be able to noninvasively and accurately sense blood sugar, but I'm glad people (especially kids with T1) will have one more tool to help them. I hope they can figure out the reimbursement side to get it into the most hands possible!
I wonder if there are any legs in an internal sensor that pushes out its reading every x? That seems pretty plausible.
Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels
#40Automated glucose control will be the next frontier in so many areas of healthcare. I'm still skeptical that anyone will be able to noninvasively and accurately sense blood sugar, but I'm glad people (especially kids with T1) will have one more tool to help them. I hope they can figure out the reimbursement side to get it into the most hands possible!
I wonder if there are any legs in an internal sensor that pushes out its reading every x? That seems pretty plausible.
Internal as in swimming in the bloodstream?