Dexcom has received FDA clearance for its innovative over-the-counter continuous glucose monitor, Stelo. This state-of-the-art device, designed specifically for Type 2 diabetes patients who do not use insulin, marks a significant leap forward in accessibility as it is the first glucose biosensor that does not require a prescription.
Scheduled for online release this summer, Stelo offers a simplified and user-friendly experience, addressing the needs of over 25 million Type 2 diabetes patients in the U.S. who do not currently use insulin. Unlike Dexcom’s existing G7 CGM system, which requires a prescription, Stelo’s over-the-counter status means it will be available to individuals without insurance coverage for CGMs.
The Stelo continuous glucose monitor utilises small sensors placed on the upper arm to provide real-time tracking of glucose levels. Its wireless connectivity sends crucial information directly to smartphones, allowing users, their families, and healthcare providers to monitor and respond promptly to potential emergencies.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasised the significance of this FDA clearance, stating, “Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider.” Dexcom’s Stelo offers a unique platform tailored to the specific needs of Type 2 diabetes patients, distinguishing itself from previous CGMs by providing a simpler experience without unnecessary alerts and notifications meant for more critical situations.
Jake Leach, Chief Operating Officer at Dexcom, expressed the company’s commitment to making Stelo widely accessible, anticipating eventual coverage by insurance companies as its benefits are demonstrated. The device boasts a 15-day lifespan before replacement, adding to its appeal for users seeking a convenient and effective monitoring solution.
Shares of Dexcom experienced a positive surge of over 2% in extended trading following the announcement, reflecting the market’s confidence in the potential impact of this revolutionary over-the-counter continuous glucose monitor. As Stelo prepares to enter the market at an “approachable” cash pay price, Dexcom aims to quickly place this invaluable tool into the hands of those who stand to benefit most, offering a personalised and insightful glimpse into the body’s intricate glucose dynamics.
