FDA Clears Dexcom Stelo Sensor, First OTC Glucose Sensor in Agency History

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The FDA has greenlit Dexcom's Stelo Glucose Biosensor System, marking a historic first as the first continuous glucose monitors to be available over-the-counter.

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration has announced the clearance of Dexcom Stelo Glucose Biosensor System, marking the first time in history the FDA has granted clearance for an over-the-counter continuous glucose monitor.

Announced on March 05, 2024, the decision comes less than 3 months after Dexcom announced it had submitted an application to the US FDA during Q4 2023 for the Stelo sensor on January 08, 2024.1,2

“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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.1 “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.”

According to the FDA, the clearance of the Stelo Glucose Biosensor System is based on data from a clinical study comparing the device against other integrated continuous glucose monitoring systems. In their release, the FDA pointed out the system is intended for anyone 18 years and older who does not use insulin, including individuals with diabetes treating their condition with oral medications or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.1

The FDA highlights the sensor is not intended for individuals with problematic hypoglycemia as the system is not designed to alert the user to this potentially dangerous condition.1

According to Dexcom, Stelo will offer 15-day sensor wear, a cash-pay option, and a software experience tailored specifically for non-insulin users. In their January 2024 earnings call, Dexcom noted plans to launch the product in Summer 2024.1,2

“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said Tamara Oser, MD, Family Physician.2 “For people newly diagnosed with Type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”

For more on the Dexcom Stelo, check out this clip from a recent episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives discussing the device and its potential. Of note: this was recorded in January prior to approval.

References:

  1. Office of the Commissioner. FDA clears first over-the-counter continuous glucose monitor. U.S. Food and Drug Administration. March 5, 2024. Accessed March 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor.
  2. Dexcom. Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter. Dexcom News. March 5, 2024. Accessed March 5, 2024. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx.
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