Dexcom Releases First OTC Glucose Monitor named Stelo

The first over the counter product for glucose monitoring is approved and offered by Dexcom, named Stelo, which the company began selling after FDA approval. The device can now be purchased over the counter without a prescription. 

Dexcom designed Stelo for individuals 18 years and older who are not on any insulin management therapy—a population that includes 25 million people with type 2 diabetes in the U.S. The device is also aimed at helping people with prediabetes achieve their A1c targets and potentially reverse the progression of diabetes, according to the company. 

Additionally, non-diabetic individuals can use the device to gain insights into how diet and physical activity affect their bodies, the company added.

Announced in January, Dexcom has positioned the Stelo as a “healthier” version of its flagship G7 CGM, which was first introduced in early 2021. While both devices share the same sensor platform, the Stelo does not include low blood sugar alerts or other software features required by people with type 1 diabetes who actively monitor their glucose data to manage their insulin intake.

The FDA cleared Dexcom’s Stelo in March, followed by Abbott in June, which received FDA clearance for two distinct CGM devices: Libre Rio and Lingo. While the Libre Rio is intended for adults diagnosed with T2DM who are not using insulin, the Lingo is a general “health and wellness” product with no specific T2DM guidance, offering blood sugar statistics to interested consumers.

The sensor is worn on the back of the upper arm, transmitting glucose measurements to a designated app installed on a smartphone, and each sensor lasts for 15 days. It is designed to provide an individualized glucose report that displays the impact of foods, activities, and sleep, without the need for finger pricks.

Dexcom EVP Jake Leach stated, “Before Stelo, what we have seen is lots of great access to CGM through a prescription and insurance reimbursement for diabetes patients on insulin, but that’s only about one-third of the people in the U.S. who have diabetes—obviously none of the prediabetes population. We have collected tons of data using Stelo with this large population group, and its main purpose was to make it more accessible.”

Stelo is a cash-pay product, priced at $99 for a pack of two sensors, which provides a total of 30 days of use. Customers can also opt for a Monthly Subscription at $89 per month, which includes two sensors every 30 days.

The company claims that the biosensor has the longest wear time on the market and boasts a waterproof level of 50m. The device provides information through the app in daily, weekly, and session summaries. The glucose biosensor also includes spike detection to identify relevant fluctuations in glucose as they occur, allowing for necessary adjustments to be made.

The device, in conjunction with the app, is intended to provide round-the-clock, straightforward glucose readouts that can guide consumers’ everyday decisions and foster healthier habits, according to company executives.