Dexcom Unveils 1st Over-the-Counter Continuous Glucose Monitor

Dexcom is targeting a potentially vast market with Stelo, particularly as the prevalence of prediabetes and Type 2 diabetes continues to rise in the United States.

Dexcom has launched its first over-the-counter continuous glucose monitor (CGM), Stelo, which is now available in the United States.

The device marks a significant shift in the availability of glucose monitoring technology, offering millions of Americans with prediabetes or Type 2 diabetes an accessible way to track their glucose levels without needing a prescription.

Stelo is primarily designed for the 125 million Americans with prediabetes or Type 2 diabetes who do not use insulin. Unlike Dexcom’s other CGMs, which are generally prescribed to patients with Type 1 or Type 2 diabetes who use insulin, Stelo is now accessible to those who cannot obtain a prescription or insurance coverage for such devices. 

Dexcom is targeting a potentially vast market with Stelo, particularly as the prevalence of prediabetes and Type 2 diabetes continues to rise in the United States.

Reportedly, the device costs $99 for a one-month supply, and users can subscribe for ongoing monthly deliveries at $89. 

Dexcom has made Stelo eligible for payment through flexible spending accounts (FSA) and health savings accounts (HSA), offering additional financial flexibility for patients.

About Stelo

Stelo, approved by the US Food and Drug Administration (FDA) in March, is a small, grey device worn on the upper arm. It measures glucose levels in real time by transmitting data wirelessly to a smartphone app. The sensor is designed to last for 15 days before needing to be replaced. 

During setup, users can select their health condition—whether they have Type 2 diabetes, prediabetes, or neither—to establish their "Target Range" for glucose levels. This range, typically between 70 and 180 milligrams per deciliter, is based on medical standards established by the American Diabetes Association.

Dexcom’s COO, Jake Leach, commented on the device’s educational purpose, stating, “The idea is to help people, over time, learn about diet choices and habits and how those are impacting glucose. It’s about uncovering things you haven’t seen before and then using that to create healthier habits.”

Dexcom has partnered with Amazon to handle Stelo deliveries, and users who subscribe can manage their delivery schedules, usually set for 30-day intervals from the initial sign-up date.

Market Implications

Stelo's launch marks Dexcom’s entry into the over-the-counter market, potentially expanding its customer base beyond those who require insulin. The device is seen as a significant move to capture the interest of millions of non-insulin-using patients, representing a large and underserved market. 

Dexcom’s competitors, including Abbott, have also received FDA clearance for similar devices, intensifying competition in the CGM market.

Introducing over-the-counter CGMs such as Stelo could have broader implications for the healthcare sector, particularly in how patients manage chronic conditions including diabetes. 

By providing a tool that does not require a prescription, Dexcom aims to empower individuals with the knowledge better to manage their health through continuous monitoring and data-driven insights.