Dexcom Stelo Secures First FDA OTC CGM Approval, Abbott Advances Freestyle Libre 3 Plus with 15-Day Wear & AID Compatibility

July 5, 2026

CNET USA

Overview

Dexcom’s Stelo achieved the first FDA approval for an over-the-counter Continuous Glucose Monitor (CGM) in 2024, significantly broadening access for general consumers. Concurrently, Abbott’s Freestyle Libre 3 Plus entered the market as a new model offering extended 15-day wear and compatibility with Automated Insulin Delivery (AID) systems. These advancements enhance user convenience and integrate CGM technology more deeply into both preventive health and advanced diabetes management.

In Depth

Key Findings

In 2024, Dexcom’s Stelo received FDA approval as the first over-the-counter (OTC) Continuous Glucose Monitor (CGM) in the United States, dramatically expanding access beyond individuals with diabetes to the general health-conscious consumer market. Simultaneously, Abbott introduced its advanced Freestyle Libre 3 Plus, featuring an extended 15-day wear duration and seamless compatibility with Automated Insulin Delivery (AID) systems, significantly improving user convenience and therapeutic integration.

Technical / Clinical Details

Dexcom Stelo: The landmark 2024 FDA approval for Stelo as an OTC device means it is now available without a prescription. This enables individuals with Type 2 diabetes not on insulin, as well as those pursuing general wellness or athletic performance optimization, to easily monitor their glucose trends. Its integration with other wearables like the Oura ring further positions it as a holistic health management tool.
Abbott Freestyle Libre 3 Plus: Building on the success of previous Freestyle Libre iterations, the 3 Plus model boasts a smaller sensor profile and an extended wear period of up to 15 days, reducing the frequency of sensor changes and patient burden. Crucially, its compatibility with AID systems offers enhanced glucose management capabilities, particularly for insulin-dependent individuals, by enabling automated insulin delivery based on real-time glucose readings.
Dexcom G7: Dexcom’s other flagship product, the G7, has also seen significant improvements, including a smaller form factor for better comfort. Its refined alert system provides timely notifications for impending hypo- or hyperglycemia, facilitating quicker intervention and improved patient safety.

Background & Context

The CGM market is fundamentally transforming diabetes care by providing real-time glucose data, empowering users to better understand and adjust their dietary and exercise habits. The emergence of OTC CGMs marks a pivotal shift, reinforcing CGM’s role in early diabetes detection, prevention, and broader wellness management. Insurers are increasingly recognizing the value of CGM technology, leading to wider coverage by health plans.

Strategic Significance & Outlook

While research into non-invasive CGM technologies continues to accelerate, minimally invasive CGMs remain the standard, prioritized for their proven accuracy and reliability. Key players in the industry are focused on further miniaturization of sensors, extension of wear duration, enhancement of AI-driven data analytics, and the development of comprehensive ecosystems that integrate with other digital health devices. These strategic initiatives are vital for maintaining competitive advantage and driving continued market growth in personalized health monitoring.

Source: https://www.cnet.com/health/nutrition/best-continuous-glucose-monitors-cgm-for-2026/

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