Ground-breaking OTC glucose monitor, Stelo, gets FDA nod for Type 2 diabetics

[BumRushDaShow]

Source: WOAI-TV San Antonio

Wed, March 6th 2024 at 7:40 PM


The FDA has approved the first-ever over-the-counter continuous glucose monitor for Americans with Type 2 diabetes.

Stelo works with a smartphone app to monitor, record, and analyze blood sugar levels.

The device maker says an estimated 25,000,000 non-insulin-dependent diabetics could benefit from continuous glucose monitoring.

The sensor is worn on the back of the upper arm, replacing the need for finger pricks.

Read more: https://news4sanantonio.com/news/instagram/ground-breaking-otc-glucose-monitor-stelo-gets-fda-nod-for-type-2-diabetics-medical-people-helping-health-sugar-community-needs

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Link to FDA NEWS RELEASE - FDA Clears First Over-the-Counter Continuous Glucose Monitor

[Aussie105]

1. I need one of those!

It will answer one of the most fundamental Human Questions:

Can I afford to eat another slice of pizza before it gets cold?

I bet they aren't cheap though.

[lapfog_1]

2. other than over the counter

how is it different than the one I've been using for years now? Freestyle Libre 3 (third model now).
Plus the Libre is one of two competing BSMs on the market.

They aren't cheap... and I worry about the amount of waste they create (plastic applicators are about the size of those top of the bottle cups you get with cough syrup, but solid ), but they are miracles of science to track my blood sugar. I plan what I will eat, when I will eat, etc based on the monitor.

[BumRushDaShow]

3. This was apparently done for "health equity" purposes

From the press release -

As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, CDRH will continue to support innovation that addresses health equity by moving care and wellness into the home setting.

I.e., I am guessing the Freestyle would need periodic script renewals where if someone is already diagnosed, they can get a monitor without needing to keep going back to a physician for a script (which adds cost and/or may be difficult in to do in rural areas).

[onetexan]

4. Does Freestyle Libre 3 require finger prick?

[lapfog_1]

10. no... all of these devices use a little attached almost flat disk attached to your arm

there is a single very small needle (like a hair size) that inserts into your arm.

I believe there is a very small reservoir of chemicals to process the blood that the needle encounters.

Then they bluetooth the results to your phone where an app will track blood glucose.

Every 2 weeks you remove this disk and attach a new one. I switch arms but I don't think you have to.

I must have been unlucky one time in the last 3 years or so and hit a vein and there was some blood on attaching the disk.

I have never experienced any pain on attaching the disk.

[Hekate]

17. Thank you! I have wondered about this.

[quakerboy]

6. Article says it should cost less for those whos insurance doesnt mitigate the costs

[lapfog_1]

11. Great... I know that the two on the market now are expensive

and only one is covered by medicare

I was hoping that it had more features or something.

[quakerboy]

19. Better price is a superb feature

I just found out the one i was recently ordered will cost me approx $300. After insurance.

[Oopsie Daisy]

5. Is the cost of both (either) covered or offset by insurance?

[lapfog_1]

12. Mine is covered by my insurance... but there is still a copay

[Oopsie Daisy]

16. That's great! I hope it stays that way *

* I had a friend whose Rx allergy meds were covered by his insurance, but when the same one was approved for OTC purchase, his Rx benefits stopped paying for it.

Be well! Take care of yourself.

[ShepKat]

7. great

so only people with smartphones can use it. Everyone can afford one of those, right ? I know I'll never own one. Can't use most apps on laptops. Another lesson in exclusion.

[BumRushDaShow]

8. Have you looked at the federal government's "Lifeline" program

which subsidizes plans - https://www.fcc.gov/general/lifeline-program-low-income-consumers

There are apparently providers who have "free" phones that come with their plan.

I was just looking at the Freestyle and that one has a "reader" device that can be used in addition to an app for a smartphone, so apparently the phone is not needed as long as you have the little reader device for that brand -



It's possible that this Stelo OTC unit will develop and sell (or come with) a separate reader for just that reason in the future.

[lapfog_1]

13. I have the reader... I got one with the first set of two monitors ( 1 month )

I use the phone app now... it has more features and will send your data to your doctor if you like (and if your doctor is set up to receive it).

[BumRushDaShow]

14. I figured that was the main difference

(basically having wifi or cell ability to "email" readings)

I would think that the way tech is now, a reader could be chipped to grab that data, put it in a simple column format format, generate a PDF, and then "email" it using VoIP over wifi.

I have a newer Omron BP unit that forces you to use an app (where their older models would let me download the data using their software through the USB port, to my older desktop and I could generate a PDF file to print for my doc). With my current one, I end up still printing from the app and handing it to the doc.

These companies usually do this to get $$$ subscriptions to their "health data services".

[Hekate]

18. Little ray of sunshine, aren't you? You *think* this is the case, so no one should have it?

smdh

[ShepKat]

33. not at all

Not even close. Off by a country mile and all those other metaphors that mean 'incredibly wrong'.

[quakerboy]

32. Why?

A free basic smartphone is available with many prepaid plans that are cheaper on the monthly than any landline ive ever had.

And I see the tents out around town offering free smart phones to low income people anytime the weather is half decent. I assume these are the "Obama phones" the repugnants used to moan about.

Then just to be sure, I looked on Craigslist. There are a plethora of used but working smartphones for under $25, no contract or plans required.

And then I looked up and the CGMs also apparently provide the option to use a reusable reader instead of a smart phone.

And if none of that works for you, there's always the standard finger stick testers, which it seems insurance companies would prefer you to use anyway.

[ShepKat]

34. eyesight, that's why

Not everyone can or has a desire to use one. I'd never own one. Apps should be available for laptops as well. My only point. I also can't look down at it like I see others do. neck issues.

[Aussie105]

9. I can see an always on monitor

and insulin pump to be essential for type 1 diabetics.

For a type 2 though, the fingerpick monitoring might be painful but it will be a lot cheaper.

Constant monitoring doesn't replace watching your food intake seeing it cannot give you a real time reading due to the delay between eating and blood sugar levels going up, but it can improve your perception of what you can and can't eat and how much you can eat, so you can avoid spikes in future.

Got my Hba1c readings down to the normal range now, but it took a few years of regular feedback from the fingerpick testing.

Worth the money for the monitor?
Obviously, it will be pushed as 'the' solution, but there is money to be made from doing so.
Up to you.

[ZERTErYNOthe]

20. It was a game change for a family member

A sibling had wildly varying finger prick readings, with high a1c, and couldn't control her glucose levels effectively, despite 5+ finger pricks a day. The Libre CGM made a huge difference. By getting more timely information she has reduced her A1C to good levels and reduced medication levels. The ability to monitor varying levels over a 24 hour span is really quite fantastic.

Now to the financial issue: I have been prescribed the same CGM, and have been denied coverage. The first time was because my doctor hadn't prescribed a very specific drug, which wasn't applicable to my condition. I appealed, and was denied. Trying again, but why does my Dr. (or me) need to go through this bullshit when coverage is not tied to health outcomes or (bear with me) the insured's health?

[Happy Hoosier]

15. I used to use a CGM....

... and wish I still could. My old Insurance covered it and it really helped me defeat T2D.

I could see the impact of basically anything I ate. I loved it.

My new insurance does not cover it. BOO!

If this is affordable enough, I'd like to start using one again.

[TexasBushwhacker]

21. Seeing the impact of what you eat in real time

could really benefit people who are trying to lose weight. We know that higher blood sugar levels make your body store fat. Wouldn't it be nice to see which foods make your blood sugar go up the least?

[NanaCat]

22. Well, darn

I'm insulin 'dependent' and a complete wimp about needles. I couldn't have one stuck in me 24/7 and not go completely mental.

[cstanleytech]

23. Unless you are very unlucky and hit the rare nerve on insertion 99% of the time you wont even notice it.

Last edited Fri Mar 8, 2024, 09:11 AM - Edit history (1)

[NanaCat]

25. And you would be wrong

Because I always feel needles.

Without fail.

[cstanleytech]

28. Oh I feel regular needles in the arm just fine but when I wear my Dexcom which is on my abdomen I almost never do.

[Lars39]

24. The sensor needles are so fine they can bend!

[NanaCat]

26. My lancets are also thin enough to bend

And I still feel them.

[Lars39]

27. You feel the delivery of the sensor filament

once every 10 days. With lancets you feel them multiple times every day.

[cstanleytech]

29. Unless of course your very unlucky and hit a nerve but since I use the abdomen I almost never do that.

[Lars39]

30. I hit a bleeder once..

That’s when I found out Dexcom will replace sensors for free.

[cstanleytech]

31. Ya, those can be frightening but they stop fairly quickly at least. Messy though.

[NanaCat]

35. If it stays in, I feel it

Some of us really are much more sensitive to needles than other people.

[Lars39]

36. These aren't much thicker than a hair.