The US Food and Drug Administration (FDA) has granted approval for Dexcom's Stelo Glucose Biosensor System, the first continuous glucose monitor (CGM) that people can purchase without a prescription. This CGM, designed for adults aged 18 and above who do not use insulin, offers real-time blood glucose measurements and trends through a smartphone application.

The Stelo Glucose Biosensor System consists of a sensor that is inserted into the upper arm, similar to Dexcom's other CGMs that require a doctor's prescription. By pairing with a smartphone application, users can conveniently monitor their blood glucose every 15 minutes. This device aims to assist individuals who manage their diabetes with oral medications or who are non-diabetic but actively control their sugar intake.

The FDA's clearance of Stelo is significant as it marks a milestone in accessibility for CGMs. While CGMs were already gaining popularity as a wellness trend on social media, this approval allows individuals to purchase a CGM without involving a healthcare provider, making it more accessible than ever before.

"CGMs can be a powerful tool to help monitor blood glucose," stated Dr. Jeff Shuren, Director of the FDA's Center for Devices and Radiological Health. "Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider. 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."

Dexcom plans to release the Stelo Glucose Biosensor System this summer. Each sensor patch is expected to last for 15 days before requiring replacement. While the cost has not been disclosed, Dexcom has emphasized that Stelo will provide an option for individuals without insurance coverage for CGMs.

The Stelo Glucose Biosensor System has the potential to be a valuable tool for individuals with insulin resistance, including those with conditions like polycystic ovary syndrome (PCOS) and other metabolic issues that increase their risk of developing diabetes in the future. Moreover, it offers insight into how diet and physical activity impact overall health.

With this regulatory approval, more individuals will have the opportunity to gain greater control over their blood glucose levels and make more informed decisions about their well-being. Dexcom's Stelo Glucose Biosensor System represents a significant advancement in the accessibility of CGMs and a step towards achieving health equity in the United States.