Sam Brusco, Associate Editor03.05.24
Dexcom has received U.S. Food and Drug Administration (FDA) clearance for Stelo, the first glucose biosensor that doesn’t need a prescription.
The company cited the about 25 million people in the U.S. with Type 2 diabetes who don’t use insulin but can still benefit from continuous glucose monitoring (CGM). Dexcom G7 is currently available for them with a prescription—Stelo’s FDA nod will facilitate this population to have access to CGM tech.
It also offers an option for those who don’t have insurance coverage for CGM.
“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 VP and COO 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.”
The company said people with Type 2 diabetes using Dexcom CGM can offer clinically meaningful improvement in time in range, A1c, and quality of life.
“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, a 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.”
Stelo will be available for purchase online without a prescription beginning summer 2024.
The company cited the about 25 million people in the U.S. with Type 2 diabetes who don’t use insulin but can still benefit from continuous glucose monitoring (CGM). Dexcom G7 is currently available for them with a prescription—Stelo’s FDA nod will facilitate this population to have access to CGM tech.
It also offers an option for those who don’t have insurance coverage for CGM.
“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 VP and COO 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.”
The company said people with Type 2 diabetes using Dexcom CGM can offer clinically meaningful improvement in time in range, A1c, and quality of life.
“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, a 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.”
Stelo will be available for purchase online without a prescription beginning summer 2024.