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FDA Clears First Over-the-Counter Continuous Glucose Monitor
U.S. Food and Drug Administration ^ | 3/5/2024 | Press Release

Posted on 03/06/2024 9:56:23 PM PST by FrogMom

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.

(Excerpt) Read more at fda.gov ...


TOPICS: Health/Medicine
KEYWORDS: cgm; dexcom; diabetes
Good news.
1 posted on 03/06/2024 9:56:23 PM PST by FrogMom
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To: ConservativeMind

Ping!


2 posted on 03/06/2024 9:57:41 PM PST by FrogMom (Time marches on....)
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To: FrogMom

That is good news. I hope the price is reasonable.


3 posted on 03/06/2024 10:02:44 PM PST by DannyTN
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To: DannyTN

I was thinking the same thing!


4 posted on 03/06/2024 10:06:38 PM PST by FrogMom (Time marches on....)
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To: FrogMom

As a Diabetes patient, this sounds very promising.

Thanks for posting.


5 posted on 03/06/2024 10:16:40 PM PST by CrimsonTidegirl (Honorary Scouser. Go Liverpool! You’ll Never Walk Alone.)
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To: FrogMom

Ironically it’s those of us who DO treat our condition with injected insulin who really NEED a device like this.


6 posted on 03/06/2024 10:28:29 PM PST by Chad C. Mulligan
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To: DannyTN

“That is good news. I hope the price is reasonable.”

Dream on, $299/month.


7 posted on 03/07/2024 2:23:04 AM PST by BobL (Trump gets my vote, even if I have to write him in; Millions of others will do the same)
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To: BobL

Well then I’ll just keep wearing my non-invasive glucose monitoring watch. Because it says my blood sugar is fine every day regardless of what I eat. And I like it so much better than my finger prick monitor that says my blood sugar is at dangerous levels.


8 posted on 03/07/2024 3:09:26 AM PST by DannyTN
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To: FrogMom

Wonder if CoupFlu vaxxes have anything to do with the timing of this announcement...


9 posted on 03/07/2024 3:45:06 AM PST by mewzilla (Never give up; never surrender!)
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To: DannyTN
Well then I’ll just keep wearing my non-invasive glucose monitoring watch.

How does it work? DO you trust its accuracy?

10 posted on 03/07/2024 7:00:36 AM PST by Lou L (Health "insurance" is NOT the same as health "care")
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To: Lou L
"How does it work? DO you trust its accuracy?"

Not at all. It works by displaying a chart that has two humps every day. The chart looks the same every day whether you eat nothing or whether you pig out on carbs. It appears to just be faking it.

Every youtube reviewer of every glucose watch came to the same conclusion.

But I continue to hear that Apple is working on one. The theory is that the watch can sense molecules in your sweat.

11 posted on 03/07/2024 12:37:00 PM PST by DannyTN
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To: Chad C. Mulligan
Ironically it’s those of us who DO treat our condition with injected insulin who really NEED a device like this.

They already have those. Freestyle Libre, Dexcom G6 and G7. I use the Dexcom G6. Alerts my phone and my wife's phone for lows (and highs, but just my phone for those).

12 posted on 03/07/2024 12:45:42 PM PST by tnlibertarian
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To: DannyTN
The theory is that the watch can sense molecules in your sweat.

Thanks for the honest assessment! I'm sure they'll have to overcome challenges, but good luck to Apple. The CGMs are a hot item in diabetes' care right now.

13 posted on 03/07/2024 1:50:09 PM PST by Lou L (Health "insurance" is NOT the same as health "care")
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To: tnlibertarian
They already have those. Freestyle Libre, Dexcom G6 and G7.

Yes, but they're by prescription, and my doctors are telling me that Medicare won't cover them.

14 posted on 03/07/2024 2:50:09 PM PST by Chad C. Mulligan
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To: FrogMom

Wait! So now we trust the FDA again?


15 posted on 03/07/2024 2:54:25 PM PST by Sirius Lee (Tonight on The Bickersons... )
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To: FrogMom

Not for Diabetes 1? I didn’t know Diabetes Type 2 tested their blood glucose levels. Shouldn’t they lose weight?


16 posted on 03/07/2024 2:57:54 PM PST by NetAddicted (MAGA2024)
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To: Chad C. Mulligan

That sucks. I didn’t know Medicare didn’t cover them. That is very shortsighted because it helps so much to prevent other problems. My last A1C was 5.3, due to my monitor.


17 posted on 03/07/2024 4:26:16 PM PST by tnlibertarian
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To: BobL; All

If “OTC” (esp. if Abbott/Freestyle Libre jumps in)...I would guess a price of around $50. per 15 day sensor/$100./mo.? I have used the Freestyle Libre CGM in the past and the co-pay was $35. per 14 day sensor.

From several articles: “Dexcom CGMs can cost around $173 a month out of pocket. The Stelo is intended to come at a more competitive price for people who have to pay out of pocket.”

https://www.msn.com/en-us/health/other/dexcom-s-new-continuous-glucose-monitor-is-a-health-tech-gadget-with-purpose/ar-AA1mPwsz


18 posted on 03/07/2024 4:42:11 PM PST by Drago
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To: Drago

Good article (rare for Western media), thanks very much!


19 posted on 03/07/2024 4:47:32 PM PST by BobL (Trump gets my vote, even if I have to write him in; Millions of others will do the same)
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To: BobL; All

No problem, I have been waiting for an “OTC” CGM for a couple of years...pain in the rear to have to convince my doc (& insurance) to write an Rx for a CGM if you are not a “full blown” Type 2 diabetic. I am hovering around a 6 on my A1c and want to see how certain foods/diet affect my blood glucose. A CGM is great compared to hourly “finger sticks”!

Also rumored is an Apple Watch blood glucose monitoring function...”vaporware” for now....very difficult to get an accurate glucose reading from an optical sensor w/o actual blood contact.


20 posted on 03/07/2024 6:31:41 PM PST by Drago
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