Dexcom’s OTC Continuous Glucose Monitor Now Available in US

The first over-the-counter (OTC) continuous glucose monitor (CGM) approved for use in the US is now available for purchase, Dexcom said in a release.¹ The company’s Stelo glucose biosensor can be purchased online as a single pack for 99$ or as an ongoing monthly subscription for 89$. Each pack contains 2 sensors which have a total wear time of 30 days.

Dexcom’s OTC Continuous Glucose Monitor Now Available in US / MichaelVi - stock.adobe.com

The Stelo glucose biosensor system was approved by the FDA in March 2024. The integrated CGM is intended for use in adults aged 18 years and older who do not use insulin or in those without diabetes who wish to better understand how diet and exercise affect blood glucose levels.² The approval was based on data from a clinical study that demonstrated the Stelo performed similarly to other integrated CGM devices.

READ MORE: FDA Approves Medtronic’s Disposable CGM

“Dexcom glucose biosensors are an essential and proven tool for diabetes management—driving strong clinical outcomes regardless of medication use and even potentially slowing the progression of diabetes,” Thomas Grace, MD, head of clinical advocacy and outcomes at Dexcom, said in a release.¹ “In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective.”

The Stelo glucose biosensor does not require any fingersticks and features the longest biosensor wear time on the market with 15 days. The system pairs with a personalized smartphone app that is easy to use and provides daily, weekly and session summary insights that helps users form healthy habits. Another key feature of the Stelo includes spike detection, which identifies meaningful glucose variability in real time.

The system’s biosensor is worn on the back of the arm and uses Dexcom’s most accurate glucose sensing technology, which is proven to help lower A1c and slow the progression of disease in individuals with type 2 diabetes. Dexcom said in the release that it’s sensors are the only ones that have been associated with significant improvements in glucose and cardiovascular risk reduction measures as early as 3 months.

The Stelo system is not cleared for use in individuals with problematic hypoglycemia, as it is not designed to alert users of low blood sugar.

“Dexcom has been at the forefront of glucose biosensing for 25 years,” Jake Leach, executive vice president and chief operating officer at Dexcom, said in a release.¹ “With the launch of Stelo, we’re defining a brand-new category and once again setting the gold standard for people to easily take control of their health. Now, millions more have access to 24/7, easy-to-understand glucose insights that can inform their daily lifestyle choices and support behavior modification.”

READ MORE: Continuous Glucose Monitoring Resource Center

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References

1. Stelo by Dexcom, the First Over-the-Counter Glucose Biosensor in the U.S., Is Now Available. News Release. Dexcom. August 26, 2024. Accessed August 26, 2024. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-the-First-Over-the-Counter-Glucose-Biosensor-in-the-U.S.-Is-Now-Available/default.aspx

2. FDA Clears First Over-the-Counter Continuous Glucose Monitor. News Release. FDA. March 5, 2024. Accessed August 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor