FDA Approves Abbott's New Over-the-Counter CGMs

In a groundbreaking move, Abbott Laboratories has secured approval from the U.S. Food and Drug Administration (FDA) for two new continuous glucose monitoring (CGM) systems, expanding their reach beyond traditional diabetic care. These innovative devices will soon be available over the counter, eliminating the need for a prescription and opening the door to a wider consumer base.

CGMs are sophisticated devices that monitor glucose levels in real-time through a small sensor that penetrates the skin, transmitting data wirelessly to a smartphone. While these devices are typically associated with diabetes management—alerting patients, their families, and healthcare providers to critical glucose fluctuations—Abbott’s new offerings promise to benefit a broader audience.

Abbott, a key player in the CGM market with six million users across 60 countries, sees substantial growth potential in these new devices. In the U.S. alone, 38.4 million people live with diabetes. The introduction of a consumer-centric CGM could revolutionize how a significant portion of this population manages their health.

The first of Abbott’s new systems, Libre Rio, is specifically designed for individuals with Type 2 diabetes who do not require insulin. The second system, Lingo, targets health-conscious consumers aiming to enhance their overall wellness. 

Lingo users will wear a biosensor on their upper arm for 14 days, tracking glucose levels through a companion app that also offers personalized coaching. This data-driven approach aims to help users "retrain their metabolism and improve their overall wellbeing," as stated by Abbott. 

The significance of Abbott’s over-the-counter CGMs cannot be overstated. Currently, programs like those offered by companies such as Signos, which utilize CGMs for weight loss and metabolic health improvements, require a prescription. Abbott’s new products could democratize access, making it easier for consumers to adopt this advanced technology.

Libre Rio marks Abbott’s first over-the-counter CGM for diabetics in the U.S., adding to a portfolio that includes similar products available without a prescription internationally. Designed for Type 2 diabetics who primarily manage their condition through lifestyle changes, Libre Rio could simplify glucose monitoring for millions.

This announcement comes on the heels of a similar FDA approval for Dexcom, a competitor in the CGM market, which received the green light for its first over-the-counter CGM earlier this year.

Abbott's new FDA-approved CGMs represent a significant step forward in accessible health technology, poised to benefit both diabetic patients and health-conscious consumers looking to take proactive control of their wellness.