This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use. In January, Dexcom first announced that it submitted the new Stelo sensor to the FDA for review at the end of last year. The San Diego-based company designed it specifically for people with type 2 diabetes who do not use insulin.
Dexcom estimates approximately 25 million people in the U.S. with type 2 diabetes who don’t use insulin but could benefit from CGM use.
The small, wearable sensor is indicated for those 18 years and older who are not using insulin therapy. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone.
Stelo features a 15-day wear based on the G7 platform. It offers a software experience tailored specifically for non-insulin users. The company said it makes it easier for the target population to access CGM and offers an option for those who don’t have insurance coverage for CGM.
The company expects to have Stelo available for purchase online without a prescription beginning in the summer.
Commentary from Dexcom and the FDA
Jake Leach, EVP and COO at Dexcom, said Dexcom “continues to lead innovation in the CGM market.” He labeled this as the latest on 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, EVP 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.”
FDA CDRH Director Dr. Jeff Shuren highlighted the importance of CGMs in measuring and monitoring blood glucose.
“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” Shuren said. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”
The analysts’ view
BTIG analysts Marie Thibault and Sam Eiber expressed their surprise at a couple of aspects of this approval. First, it came well ahead of their expected timeline, although launch plans for the summer remain the same. Additionally, the over-the-counter element “came as a surprise,” given Dexcom’s previous expectation of a cash-pay option requiring a prescription.
The analysts also note that, while Dexcom didn’t disclose pricing plans, they expect competitive pricing compared to its CGM peers. They also think Dexcom can exceed their revenue targets because of the broader over-the-counter access.
Thibault and Eiber maintained a “Buy” rating for Dexcom.
“We continue to think this is an underappreciated opportunity given how large the non-insulin-using [type 2] patient pool is relative to the T1D and T2D insulin-using population,” the analysts said.
