Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

An over-the-counter continuous glucose monitoring (CGM) solution developed by Dexcom called Stelo has received clearance from the Food and Drug Administration (FDA).

Available without the need for a prescription, the wearable biosensor boasts a battery life of up to two weeks and adheres to the back of the upper arm. 

The patch aids in the detection of normal (euglycemic) as well as low or high (dysglycemic) glucose levels.

It provides round-the-clock glucose readings directly to a smartphone and delivers personalized insights into glucose health, offering users actionable information to make informed decisions.

Tailored for individuals 18 and up who do not require insulin, the target group includes those managing diabetes with oral medications or individuals who need information on the impact of lifestyle factors like diet and exercise on blood sugar levels.

The FDA clearance noted the system is not indicated for individuals experiencing problematic hypoglycemia.

Stelo is slated to be available for purchase online starting in summer 2024, and pricing will be released at the launch.

THE LARGER TREND

Approximately 38 million people in the U.S. are afflicted with diabetes, with 90 to 95% of them having type 2 diabetes. 

The integration of CGM technology has the potential to empower individuals managing diabetes by offering insights into the nuanced effects of various foods and physical activities on their glucose levels.

Glucose monitoring with smartphone connectivity eliminates the need for frequent finger sticks for treatment decisions.

Dexcom also announced a phased rollout of its “direct to Apple Watch” functionality, starting in the second quarter of this year, which makes the CGM system capable of connecting directly to the Apple Watch without requiring an iPhone. The feature will be available to all G7 iOS users.

DexCom isn’t the only player in digital diabetes management. Kakao Healthcare recently launched its latest AI-driven mobile diabetes management app called PASTA (Personalized, Accessible, Supportive, Tech-enabled, and Affordable).

The app links to two CGM devices–the CareSens Air by manufacturer i-SENS and Dexcom’s G7.

Valendo Health, a diabetes-focused endocrinology company, provides telehealth and remote patient monitoring services staffed by diabetes care clinicians, an endocrinology-focused EMR, data analytics and support for value-based care contracting.