Dexcom Stelo OTC Continuous Glucose Monitor Reaches One Million Users
Dexcom has announced that its Stelo continuous glucose monitor — the first OTC CGM approved by the FDA — has reached one million users, with the majority being people without diabetes who are using the device for metabolic health optimization.
Dexcom has announced that its Stelo continuous glucose monitor — the first over-the-counter CGM approved by the FDA — has reached one million users. The milestone, reached approximately 18 months after the product's commercial launch, reflects strong consumer demand for real-time metabolic health data from people who do not have diabetes and are not using the device for clinical management of a chronic condition.[1]
Stelo received FDA clearance in March 2024 as the first CGM cleared for use without a prescription. Unlike Dexcom's clinical CGM products, which are designed for people with Type 1 or Type 2 diabetes and require a physician prescription, Stelo is available directly to consumers through retail pharmacies and online channels at a price of approximately $99 for a 30-day supply of two sensors.[2]
The Non-Diabetic Market
Dexcom's data indicates that the majority of Stelo users — approximately 65% — do not have a diabetes diagnosis. These users are primarily motivated by interest in understanding how food, exercise, sleep, and stress affect their blood glucose levels, and by the broader trend toward continuous, personalized health monitoring that has been driven by consumer wearables including the Apple Watch and Whoop band. The non-diabetic CGM market has been pioneered by companies including Levels and Signos, which built subscription software platforms on top of prescription CGM hardware before the OTC category existed.[3]
AI Integration
Dexcom has integrated AI-powered insights into the Stelo app, which analyzes glucose patterns and provides personalized recommendations for food choices, meal timing, and activity. The AI layer is designed to translate raw glucose data — which can be difficult for non-clinical users to interpret — into actionable guidance that does not require medical expertise to understand. The company is also exploring integrations with third-party health platforms including Apple Health and Google Fit to allow Stelo data to be combined with other health metrics for more comprehensive metabolic health analysis.[1]
References
- Dexcom. "Dexcom Stelo Reaches One Million Users." April 18, 2026. https://investor.dexcom.com/news-releases/news-release-details/dexcom-stelo-reaches-one-million-users
- FDA. "FDA Clears First Over-the-Counter Continuous Glucose Monitor." March 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor
- Rock Health. "The Consumer CGM Market: From Prescription to OTC." 2025. https://rockhealth.com/insights/the-consumer-cgm-market/
Companies in this article
DexcomSan Diego, CA, USA · Founded 1999Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management, providing real-time glucose readings.View company profile →
SignosBurlingame, CA, USA · Founded 2020Signos pairs continuous glucose monitoring with AI to tackle weight management and bring visibility into metabolic function for better health.View company profile →Reporting & accountability
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