Dexcom wins FDA Approval for a over the counter CGM (continuous glucose monitoring) device

Dexcom Stello CGM

Dexcom finally just got the FDA approval for an over-the-counter continuous glucose monitoring device. 

This is a huge moment for the industry as it will drive down the costs of CGMs and make them more consumer-friendly.

Many physicians and even regulators have long held the view that CGMs are only appropriate for people with diabetes, primarily a small subsegment; Type 1 or Type 2 diabetes that is hard to control.

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According to the Centers for Disease Control and Prevention, approximately 98 million American adults—more than 1 in 3—have prediabetes. Of those with prediabetes, more than 80% don’t know they have it.

Furthermore, there are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology. 

An over-the-counter continuous glucose monitor will be a game changer for many folks who want to manage their prediabetes. Although companies such as Levels, Veri and others have tried to make a mark for themselves in the metabolic health segment, scaling has been hard due to a variety of issues.

Dexcom’s new Stelo is the first glucose biosensor cleared by FDA as over-the-counter. This is a small, wearable sensor worn on the back of the upper arm. Once placed, Stelo will provide glucose insights directly to a user’s smartphone.

Stelo will empower even more people with Type 2 diabetes not to use insulin to take control of their health. “Based on our experience serving people with Type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”, said Jake Leach in the company’s press release.

Stelo will be available for purchase online without a prescription starting summer 2024.

As CGMs become more accessible, the market will likely consolidate around companies that offer the best content, community, and software. This will raise the bar for CGM software companies, and the need to invest in those areas to stay alive.

This development also ups the ante on wearable companies such as Apple, Garmin, Google, and Samsung to reevaluate their wearable sensor portfolio and associated future projects in the space, particularly on any efforts surrounding the development of non-invasive continuous glucose monitoring.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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