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Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

fiercebiotech.com

81–86 of 86 posts

Re: Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

#81

Earlier quoted context omitted.

This... brought back some memory...to average or not to average... C8 Medisensors achieved better weekly MARD in the early 201*. But the problem was, on a bad day, no one knows why it was bad..., so no way to alert the user (unless the reading was way off). Even though on "average", performance looks nice, but a bad day the data can be very problematic for a user, and the user has not way to trust the device based on…

This is a great point, and precisely why we're using two sensors and a simple voting algorithm in our first in man trial (3+ sensors and associated algorithms were deemed too risky by FDA for initial studies).

Not sure what sensors you are using... why FDA thinks more sensors carry higher risk?

Re: Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

#82
post #74
post #57

Earlier quoted context omitted.

Sounds like you didn't idiot-proof your proposal. A lot of good paper writing guidelines, like explain value of contribution fast and early, could be phrased as idiot-proofing.

Maybe. But maybe you don't know how SBIR grants work. I consider them highly corrupt and I was told by people who got them how they got them and they even advised me, not to waste my time (two person, both hat P1 and P2). The solicitation was for non-invasive BGM. Of the accepted proposals, nothing came out. Big surprise. At least I got a very high rating for "originality" of our approach.

You're right, I don't know anything about your specific case.

Re: Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

#83

Earlier quoted context omitted.

so what foods did you cut out, and what foods do you regularly eat?

Everybody's body responds differently, so you have to experiment to see what works for you. The CGM has been a great tool for that. I also use a Keto-Mojo for blood glucose and ketone testing now and then. What's worked for me is a diet of eggs, cheese, bacon, chicken, ground beef, ground pork, roast beef, turkey, pepperoni, kale, cabbage, Brussels sprouts, coffee, seltzer, bone broth, half & half, heavy cream, rebel…

As a T2, I would encourage you to be careful about the almonds, kale, and other items that are high in Oxalate.

Trust me, you really don’t want to develop kidney stones.

Been there, done that, twice. Had to go to the ER each time. Not fun.

Re: Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

#84

Earlier quoted context omitted.

This is a great point, and precisely why we're using two sensors and a simple voting algorithm in our first in man trial (3+ sensors and associated algorithms were deemed too risky by FDA for initial studies).

Not sure what sensors you are using... why FDA thinks more sensors carry higher risk?

It's not the number of sensors, it's the novelty of the voting algorithm required to fuse those sensors that gives them pause. FDA likes to be _VERY_ conservative when it comes to trying new things. We're trialing our control software, which is already novel to them, so anything we can do that's not brand new helps reduce our risk.

Re: Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

#85
post #48

I find some of the this vague in this announcement. Non invasive BGM is the "holy grail" in this field. Tons of companies have failed after big investments. Some scammers are out there they claim since decades they solved the problem. I would be curious about peer reviewed publications of their technology. A friend of mine is working on this too. Close to market. He is the only one that regularly published peer revie…

PS: Forwarded it to my buddy (Professor).

Quote: "interesting but approach wont work"

Re: Know Labs unveils glucose monitor that swaps fingersticks for RF sensors

#86

Earlier quoted context omitted.

Not sure what sensors you are using... why FDA thinks more sensors carry higher risk?

It's not the number of sensors, it's the novelty of the voting algorithm required to fuse those sensors that gives them pause. FDA likes to be _VERY_ conservative when it comes to trying new things. We're trialing our control software, which is already novel to them, so anything we can do that's not brand new helps reduce our risk.

More information should help make more informed devision, if the algorithm can not clearly explain it to FDA or FDA cannot understand that is the case... something seems wrong here... all the best wishes and also encourage more exploration.
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