posted in Technology

The FDA just picked its first company to sell an unauthorised device to Medicare patients

thenextweb.com/news/fda-tempo-pilot-dexcom-first-participant-enforcement-discretion
TNW | Artificial-intelligenceThe FDA just picked its first company to sell an unauthorised device to Medicare patientsThe US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as TEMPO, allows digital health devices to be offered to Med

Replying to @⁨RobotToaster@mander.xyz⁩

For more context for people who don’t know. You can buy CGM devices over the counter from places like Walmart and Amazon.

They attach to your body and monitor your blood glucose via a small “thread” that goes into your skin when it’s applied. They typically cost $50 for two weeks.

The OTC version has been around for a shorter period of time than the ones that require a prescription, but work the same way. The OTC ones tell you they are not for diagnosing diseases. Or for people who rely on insulin.

And Dexcom, the company in the article, is the most prominent vendor for these sorts of things. “A Dexcom” is the “Kleenex” for CGM in the type 2 diabetes world. From what I’ve seen.

RFK has been talking about wanting all Americans to use CGM for a long time now. This is part of that. The MAHA people talk about metabolic stuff like it’s the solution to our fucked up food culture in the US.

I use a CGM. But I can’t help but be suspicious of RFK.

Rumors are that Apple has been dumping money into figuring out how to make the Apple Watch do CGM. They have been chasing it for years.

Replying to @⁨paraphrand@lemmy.world⁩

Unfortunately there are very few actual CGM brands available. There are a bunch of different CGMs, but most of them are just relabels of other units, almost all of which are made by either Dexcom or Abbott. Even more unfortunately in my experience they wildly exaggerate the accuracy and lifetime of the units. Most claim an accuracy of +/- 20% which is pathetic for 14 days, but you’re lucky if it maintains even that terrible level of accuracy for half that time.

In my case I’m horrendously allergic to the adhesive that Dexcom uses on their units, so I can’t even use half the CGMs on the market, and I gave up on Abbott after their units started to struggle to even make it 48 hours without being off by more than 50 mg/dl.

Replying to @⁨orclev@lemmy.world⁩

I feel like I’m a Stelo unicorn. I’ve had good luck, and when I check with a finger prick it’s always close. I don’t use insulin. So it’s fine for my needs.

I suspect my body/arm/skin is ideal for the technique these use. And I think a large subset of people never have as good of luck. If you look on Amazon, you see the CGMs always have 2.5-3 stars. And in a broken place like Amazon where reviews are somehow always 4-4.5, this really shows how much you are rolling the dice with the OTC ones. But like I said, it’s been working for my needs.

It’s clear this market is proven and is valid. I hope breakthroughs in tech can happen to improve reliability, and longevity. If someone like Apple figures out how to do it with a watch style device, it’ll be really fantastic.

Edited ⁨⁨Aug⁩ ⁨3⁩, ⁨2026⁩, ⁨01:39⁩⁩en