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Dexcom's Stelo Cleared by FDA as Over-the-Counter

Mar 6, 2024
Stelo by Dexcom, the first glucose biosensor cleared by the FDA for over-the-counter use, will be available in the US for individuals aged 18 and older not using insulin therapy, making it accessible without a prescription. This small, wearable sensor, worn on the upper arm, will transmit glucose data directly to the user's smartphone. Developed by Dexcom, Stelo aims to empower people with Type 2 diabetes to manage their health effectively. Available from summer 2024 onwards, Stelo fills a crucial gap in the market, providing continuous glucose monitoring for those without insurance coverage or prescription access.

DexCom's latest device, Stelo, marks a milestone in continuous glucose monitoring (CGM) technology, as it becomes the first glucose biosensor cleared by the FDA for over-the-counter use in the United States. Designed specifically for individuals aged 18 and older who are not utilizing insulin therapy, Stelo offers a new avenue for accessing CGM without the need for a prescription. This development addresses a crucial need within the diabetes community, particularly for the approximately 25 million individuals in the US living with Type 2 diabetes who do not use insulin and can benefit from CGM technology.

Stelo's design features a small, wearable sensor that is worn on the back of the upper arm, providing users with continuous insights into their glucose levels directly on their smartphones. By offering real-time glucose monitoring without the constraints of insurance coverage or prescription requirements, Stelo opens doors for greater accessibility and autonomy in diabetes management.

Clinical evidence supports the benefits of continuous glucose monitoring in managing Type 2 diabetes, with studies demonstrating improvements in time in range, A1c levels, and overall quality of life. However, for many individuals newly diagnosed with Type 2 diabetes or those not utilizing insulin therapy, access to CGM devices may be limited due to insurance coverage constraints. Stelo addresses this gap by offering a user-friendly, over-the-counter solution that empowers individuals to proactively manage their diabetes without barriers.

Stelo is anticipated to launch in the summer of 2024.

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ADCES and danatech curate product specifics and periodically review them for accuracy and relevance. As a result, the information may or may not be the most recent. We recommend visiting the manufacturer's website for the latest details if you have any questions.

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