if you want to sell this over-the-counter the FDA is going to say it cannot be used by someone to dose insulin
The headline is broadly defensible, but the qualifications matter. Effect sizes vary by population, the strongest claims rest on shorter trials, and credible voices push back on how it's typically framed.
if you want to sell this over-the-counter the FDA is going to say it cannot be used by someone to dose insulin
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Bookmarking — the dossier-vs-overview split is the right call. Most of the time I want overview; sometimes I want receipts.
Would love a "what would change this verdict" RSS feed. Sign me up if it exists.
the other option for making this OTC is not to take the same device and just deal with the FDA changing a rule but it's to create a device that would fit into the current sort of regulatory environment which says the device would basically have to be dumbed down you'd basically have to strip functionality out of the device right strip functionality and the user experience yeah not necessarily accuracy no in that performance but strip down the information that's presented to the individual
another way is as you said you just show ranges colors the circles on your Apple watch
if you want to sell this over-the-counter the FDA is going to say it cannot be used by someone to dose insulin
at some point in time again as we look to the future and as you and I have talked unlike a device we could sell over-the-counter or we could sell through nutrition programs that a patient couldn't use to dose insulin but what would be the real-time feedback you'd give somebody's explained why that's necessary
the ways that that can be done is one you could make it such that they don't get real-time information because if you don't real-time information if you see the perfectly accurate identical data a day later doesn't help you dose insulin
Post-meal glucose spikes in non-diabetics drive long-term cardiometabolic disease independently of HbA1c.
Wearing a continuous glucose monitor leads to personalized dietary improvements that hold up beyond 12 weeks.
Continuous glucose monitors meaningfully change behavior in non-diabetic adults beyond the first month.
CGM use in metabolically healthy adults induces orthorexic-style dietary anxiety without health benefit.