Stelo will be the first glucose biosensor in the US certified for non-prescription use. It’s designed for patients who have type 2 diabetes that does not produce insulin.
The press release from Dexcom states that around 25 million Americans with Type 2 diabetes do not take insulin.
DexCom, the global leader in real-time CGM for people with diabetes based in San Deigo, California, said today that the FDA has approved Stelo. Stelo is Dexcom’s first glucose biosensor, which requires a prescription. During the summer, it will also be sold online.
These Continuous Glucose Monitors (CGM) are small sensors that penetrate through the skin and check glucose levels in real time. They are mostly used by diabetics because the information is wirelessly transmitted to a smartphone, which can warn users, their families, and doctors of emergencies. They are also meant for anybody 18 and older who does not use insulin, such as people with diabetes who treat their illness with oral drugs or non-diabetics who wish to learn more about how diet and exercise affect blood sugar levels. Dexcom also stated that it will be accessible to people who do not have CGM insurance coverage.
Dexcom’s Stock Jumps After OTC CGM Announcement
The press release from Dexcom states that around 25 million Americans with Type 2 diabetes do not take insulin. This demographic can use the G7 CGM system that Dexcom currently offers; however, it requires a prescription. It is, therefore, only readily available to some Type 2 patients.
Dr Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, stated that CGMs are a useful instrument for blood glucose monitoring. The approval granted today increases access to these devices by enabling people to buy a CGM on their own without a doctor’s assistance. In Tuesday’s extended trading, Dexcom’s shares have increased by almost 2%.
Stelo’s name was disclosed by Dexcom, along with the information that the gadget had been submitted for FDA approval in February. The Dexcom website states that the upper arm sensor has a maximum 15-day lifespan before needing to be changed.
Dexcom Aims for Wider Stelo Adoption
Jake Leach, chief operating officer at Dexcom, said in an interview in February that Stelo will have its unique platform and branding. The platform will be catered to the needs of these Type 2 patients, he said. This means it will not include many of the alerts and notifications meant for diabetes patients at risk of experiencing more serious emergencies. He also stated that it’s designed for a simpler experience, and many people could benefit from it.
According to Leach, Dexcom thinks insurance companies would eventually foot the bill for Stelo as long as the company can prove its benefits. He also stated that Dexcom made the decision to launch the product at a cash-pay pricing that was “approachable” in order to facilitate its rapid user adoption.He remarked that, it was important for people to have that insight—it’s like a mirror into their body. It is indeed very personal.
Dr. Tamara Oser, MD, a family physician based in Colorado, also stated that the use of CGM will help people understand the effect of different foods and activities on their glucose values. Stelo offers people an opportunity to offer valuable information that can impact their diabetes management, and that too without insurance or prescription.
Dexcom’s Stelo revolutionises blood sugar monitoring by offering the first prescription-free CGM. This user-friendly option empowers people with Type 2 diabetes and those curious about their health to gain valuable insights. Studies linked Dexcom’s CGMs to improved blood sugar control and quality of life suggest Stelo has the potential to transform diabetes management and personal health understanding for millions.