Dexcom a leader in continuous glucose monitoring (CGM) technology, has achieved a significant milestone with the clearance of its new over-the-counter (OTC) continuous glucose monitor named Stelo by the U.S. Food and Drug Administration (FDA). This approval marks a pivotal moment in diabetes management, offering increased accessibility and convenience for individuals seeking real-time glucose monitoring solutions.
Continuous glucose monitors, such as Dexcom’s Stelo, are compact sensors that penetrate the skin to provide continuous tracking of glucose levels. These devices play a crucial role in diabetes management by wirelessly transmitting data to smartphones, enabling users, their families, and healthcare providers to monitor glucose levels and respond promptly to potential emergencies.
What sets Stelo apart is its accessibility without the need for a prescription, making it the first OTC glucose biosensor approved by the FDA. This groundbreaking feature opens doors for individuals with Type 2 diabetes who do not require insulin therapy, providing them with a user-friendly tool for glucose monitoring without insurance barriers.
Dexcom’s Over-the-Counter CGM Innovation
According to Dexcom, over 25 million individuals in the U.S. with Type 2 diabetes do not rely on insulin for treatment. While Dexcom’s existing G7 CGM system caters to this demographic, the requirement for a prescription limits accessibility. With Stelo, Dexcom aims to bridge this gap, offering a solution readily available for purchase online, starting this summer.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasized the significance of Stelo’s clearance in expanding access to CGM technology. By enabling individuals to acquire CGMs without healthcare provider involvement, Dexcom innovation promises to empower users with valuable health insights, irrespective of their access to medical care or insurance coverage.
The Stelo system comprises a wearable sensor paired with a smartphone application or reader device. It continuously measures, records, analyzes, and displays glucose values every 15 minutes, providing users with comprehensive data to manage their condition effectively. Each sensor boasts a lifespan of up to 15 days before replacement, ensuring long-term monitoring capabilities.
Jake Leach, Chief Operating Officer at Dexcom, emphasized Stelo’s tailored platform for Type 2 diabetes patients. Unlike traditional CGMs, Stelo offers a simplified user experience, omitting complex alerts and notifications geared toward insulin-dependent individuals. Leach highlighted the importance of providing a seamless monitoring solution that resonates with the unique needs of this demographic.
Revolutionizing Glucose Monitoring Accessibility
Furthermore, Dexcom’s decision to introduce Stelo at an accessible price point reflects its commitment to facilitating swift adoption among users. While insurance coverage remains a consideration for future reimbursement, Dexcom prioritizes making Stelo available at a “cash pay” price to expedite its availability to the market.
In light of the FDA clearance, Dexcom anticipates significant interest and uptake of Stelo among individuals seeking reliable glucose monitoring solutions. By democratizing access to CGM technology, Dexcom aims to empower individuals with a deeper understanding of their health, enhancing overall health equity for patients across the United States.
Dexcom’s Stelo represents a significant advancement in diabetes management, offering a user-friendly, over-the-counter continuous glucose monitoring solution tailored for individuals with Type 2 diabetes. With FDA clearance secured, Dexcom looks forward to delivering Stelo to consumers this summer, marking a new era in accessible and convenient glucose monitoring technology.
