The US Food and Drug Administration has approved the first continuous glucose monitor (CGM) that people can buy without a prescription. Dexcom Stelo Glucose Biosensor System It has a sensor that users must insert into their upper arm, similar to the company's other CGMs that require a prescription to purchase. It is combined with a smartphone application that can display the user's blood glucose measurements and trends every 15 minutes.
The company designed the device specifically for adults 18 and older who do not use insulin, such as those who manage their diabetes with oral medications and non-diabetics who make a conscious effort to control their sugar intake. It could be a great tool for people with insulin resistance, including people with polycystic ovary syndrome and other metabolic problems that increase their chance of developing diabetes in the future. Overall, it could provide users with the information needed to better understand how the foods they eat and the movements they make impact their overall health.
While CGMs are nothing new, they became a wellness trend on social media last year, and even non-diabetics started using them. By approving Stelo, the FDA is making monitors more accessible than before. “CGMs can be a powerful tool to help control blood glucose,” said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. “Today's authorization expands access to these devices by allowing people to purchase a CGM without the involvement of a healthcare provider. Providing more people with valuable information about their health, regardless of their access to a doctor or health insurance, “It is an important step forward in promoting health equity for American patients.”
Stelo will be available starting this summer. Each patch should last 15 days before users have to replace it. Dexcom has not yet revealed how much it would cost, but said Stelo will “provide an option for those who do not have insurance coverage for CGM.”
