FDA Clears First Over-the-Counter Continuous Glucose Monitor

[Bob]

FDA Clears First Over-the-Counter Continuous Glucose Monitor

For Immediate Release: March 05, 2024

 

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. 

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values in people 18 years and older that are not on insulin and who do not have problematic hypoglycemia. Users can wear each sensor up to 15 days before replacing with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app. Users should not make medical decisions based on the device’s output without talking to their healthcare provider. 

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation and pain or discomfort.

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.

ARTICLE SOURCE: https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor

[Geezy]

I saw that on Baker’s video today.
I don’t know if I’ll ever try one but I can see where it would be interesting to track what happens throughout the day.


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[Bob]

Yes it would. If I struggled to lose weight then I would be more interested in monitoring this. But I do just fine so I must be eating right

[Orweller]

Good news for diabetics. I think for the the rest of us, maybe a bit redundant. 

[Bob]

23 minutes ago, Orweller said:

Good news for diabetics. I think for the the rest of us, maybe a bit redundant. 

I agree. Some who are just dipping their toes into low carb diets, but not committing to a strict whole food keto or carnivore diet, get interested in these, as does those who want to start adding back foods and want to see what said food does to their blood sugar levels.

I know what works for me, so I don't have much of an interest myself.

[Qapla]

Dexcom's Stelo will cost around $90 a month

The new device should add $31 million in sales this year after launching this summer. That's below Dexcom's guidance for 1% of sales, which comes out to about $42.5 million at the midpoint of the company's guidance. Conservatively, that could amount to $200 million in 2025 sales, or about 5% of total U.S. sales.

It all depends on how Dexcom opts to promote the product. People with prediabetes will be the low-hanging fruit. But there are other metabolic health uses, including nutrition, weight loss and athletic performance. Dexcom stock has made a strong comeback since October as enthusiasm for the metabolic health space grows.

Dexcom Stock Breaks Out As FDA Clears It To Enter A New Market: Obesity | Investor's Business Daily (investors.com)

[Orweller]

3 minutes ago, Qapla said:

Dexcom's Stelo will cost around $90 a month

The new device should add $31 million in sales this year after launching this summer. That's below Dexcom's guidance for 1% of sales, which comes out to about $42.5 million at the midpoint of the company's guidance. Conservatively, that could amount to $200 million in 2025 sales, or about 5% of total U.S. sales.

It all depends on how Dexcom opts to promote the product. People with prediabetes will be the low-hanging fruit. But there are other metabolic health uses, including nutrition, weight loss and athletic performance. Dexcom stock has made a strong comeback since October as enthusiasm for the metabolic health space grows.

Dexcom Stock Breaks Out As FDA Clears It To Enter A New Market: Obesity | Investor's Business Daily (investors.com)