Dexcom Announces Availability, Pricing of Stelo—First OTC Glucose Sensor

Dexcom’s Stelo, the first US Food and Drug Administration (FDA)-cleared over-the-counter (OTC) glucose sensor, is available in the US beginning on August 26, 2024 and can be purchased for as low as $89.99 for a 2-pack from Stelo.com.

Ushering in a new age of consumer-facing health management and continuous glucose monitoring (CGM), the Stelo sensor allows for a 15-day wear time and will be sold through pay-as-you-go or subscription formats. According to Dexcom, which pointed out that the Stelo will also be HSA/FSA eligible, pay-as-you-go customers will pay $99 for a single pack of 2 sensors for a total wear time of up to 30 days and subscribers can save 10% by paying $89 per month for an ongoing subscription of the same 2-sensor pack delivered every 30 days.

“Dexcom glucose biosensors are an essential and proven tool for diabetes management – driving strong clinical outcomes regardless of medication use and even potentially slowing the progression of diabetes,” said Thomas Grace, MD, head of clinical advocacy and outcomes at Dexcom.¹ “In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective.”

The public first learned of the regulatory application for the Stelo during a January 2024 earnings call from Dexcom. On March 05, 2024, the FDA announced clearance of the system for anyone 18 years and older who does not use insulin, such as 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. According to the FDA, the clearance was based on a clinical study demonstrating the device performed similarly to other integrated CGMs.^2,3

In their release announcing availability, Dexcom called attention to several Stelo features of note beyond the 15-day wear time, which the company purports is the longest biosensor wear time on the market. Other features highlighted by Dexcom included the Stelo’s specific design for use without fingersticks, a high waterproof rating, the ability to identify meaningful glucose variability in real-time, and a personalized app, which can provide daily, weekly and session summary insights to users.¹

“Dexcom has been at the forefront of glucose biosensing for 25 years. With the launch of Stelo, we’re defining a brand-new category and once again setting the gold standard for people to easily take control of their health,” said Jake Leach, executive vice president and chief operating officer at Dexcom.¹ “Now, millions more have access to 24/7, easy-to-understand glucose insights that can inform their daily lifestyle choices and support behavior modification.”

The Stelo was the first of 3 OTC glucose sensors to receive clearance thus far through 2024. On June 10, 2024, Abbott announced the FDA clearance of the Lingo and Libre Rio. According to Abbott, the Lingo is designed for consumers 18 years and older who are looking to improve their overall health and the Libre Rio is designed for people ages 18 and older with type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.⁴

References:

1. Dexcom Inc. STELO BY DEXCOM, THE FIRST OVER-THE-COUNTER GLUCOSE BIOSENSOR IN THE U.S., IS NOW AVAILABLE. Dexcom Inc. August 26, 2024. Accessed August 26, 2024.
2. Campbell P. FDA clears Dexcom Stelo sensor, first OTC glucose sensor in agency history. HCP Live. March 5, 2024. Accessed August 25, 2024. https://www.hcplive.com/view/fda-clears-dexcom-stelo-sensor-first-otc-glucose-sensor-in-agency-history.
3. 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.
4. Abbott. Abbott receives U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems. Abbott MediaRoom. June 10, 2024. Accessed August 25, 2024. https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-U-S-FDA-Clearance-for-Two-New-Over-the-Counter-Continuous-Glucose-Monitoring-Systems.