Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter

DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription. There are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology. Today, Dexcom G7 is available for them with a prescription. Stelo, cleared for use without a prescription, will make it even easier for this population to access leading CGM technology, and will provide an option for those who do not have insurance coverage for CGM.

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Stelo will be the first glucose biosensor in the US cleared for use without a prescription (Photo: Business Wire)

“Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances. Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks^‡ for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “Based on our experience serving people with Type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”

Continuous glucose monitoring plays an integral role in the management of Type 2 diabetes and the benefits are proven when used alone, or alongside other diabetes and weight management medications.⁸ Studies show the use of Dexcom continuous glucose monitoring by people with Type 2 diabetes is associated with clinically meaningful improvement in time in range, A1c and quality of life.^9-12

“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said Dr. Tamara Oser, MD, Family Physician. “For people newly diagnosed with Type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”