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Dexcom's Stelo Receives FDA Clearance as the First Over-the-Counter Glucose Biosensor

Wednesday, March 06, 2024

DexCom, known as a leading provider of continuous glucose monitoring solutions for individuals managing diabetes, has announced a significant milestone: the FDA has approved Stelo by Dexcom, making it the first glucose biosensor that does not require a prescription. In the United States, an estimated 25 million people with Type 2 diabetes who are not insulin-dependent can potentially benefit from continuous glucose monitoring (CGM) technology. While Dexcom G7 is currently accessible by prescription, the clearance of Stelo for non-prescription use aims to streamline access to advanced CGM technology for this specific demographic. Moreover, Stelo offers an option for individuals without insurance coverage for CGM devices.

Dexcom remains a frontrunner in CGM innovation, having pioneered various advancements such as integrating CGM with multiple insulin delivery devices, smartphone connectivity, and eliminating the need for fingersticks in treatment decisions. With the introduction of the first FDA-cleared over-the-counter glucose biosensor, Dexcom has carved a new path in continuous glucose monitoring. CGM plays a crucial role in managing Type 2 diabetes, demonstrating tangible benefits when used either independently or alongside other diabetes and weight management treatments.

Studies indicate that the use of Dexcom continuous glucose monitoring among individuals with Type 2 diabetes leads to notable improvements in time spent within target glucose ranges, A1c levels, and overall quality of life. For those recently diagnosed with Type 2 diabetes or individuals not utilizing insulin, insurance coverage for these devices is often lacking. Stelo presents an opportunity to provide valuable insights that could positively influence diabetes management in this underserved population.




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