FDA clears first OTC continuous glucose monitor

Key Takeaways

  • The first over-the-counter continuous glucose monitor (CGM) was cleared for sale by the FDA.
  • The CGM was approved for adults with diabetes who use oral medication as well as for adults without diabetes.

The first over-the-counter continuous glucose monitor (CGM) was cleared for use by adults with or without diabetes, the FDA announced. The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) for adults with type 2 diabetes who don’t use insulin, such as those who only manage their condition with oral agents. The device is also cleared for adults without diabetes who want to better understand how diet and exercise may impact blood sugar levels. It will be available online without a prescription by this summer.

The Stelo iCGM system features a wearable sensor — worn on the back of the upper arm for up to 15 days before replacement — paired with a smartphone or smart device application to continuously measure, record, analyze, and display glucose values. It can provide blood glucose measurements every 15 minutes on the app.

“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 healthcare provider,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”

That being said, the device is not indicated for patients with problematic hypoglycemia since it’s not designed to alert for low blood sugar levels like other systems. In addition, the FDA warned that “users should not make medical decisions based on the device’s output without talking to their healthcare provider.” 

Source: Kristen Monaco, Medpage Today, March 6, 2024; see source article