The Stelo glucose biosensor will be made available in the US. Credit: Business Wire/ DexCom.

DexCom has received the US Food and Drug Administration (FDA) approval for Stelo by Dexcom glucose biosensor as an over-the-counter product.

Said to be the first glucose biosensor in the US cleared for use without a prescription, the Stelo continuous glucose monitoring (CGM) system is designed for individuals aged 18 and older.

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Stelo is a small, wearable sensor that can be placed on the back of the upper arm. It can provide glucose readings directly to a user’s smartphone.

This development is poised to benefit approximately 25 million Americans living with type 2 diabetes (T2D) who do not use insulin, the company said.

Dexcom executive vice-president and chief operating officer Jake Leach said: “Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances.

“Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter.

“Based on our experience serving people with type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”

Dexcom plans to make available the Stelo biosensor for purchase online without a prescription, starting mid-2024.

CGM is a critical tool in managing T2D, offering benefits whether used alone or with other diabetes and weight management medications.

Research demonstrates that using Dexcom’s CGM technology can lead to significant improvements in glycemic control, including better time in range, reduced A1c levels, and enhanced quality of life for individuals with T2D.

In 2022, the FDA approved Dexcom’s next-generation Dexcom G7 CGM System for use in people aged two years and above with all types of diabetes.