FDA-Approved Over-the-Counter Libre Rio: Features and More

Since years, continuous glucose monitors (CGMs) could only be obtained by prescription and were mainly used by individuals with Type 1 diabetes or by individuals who require insulin. However, today, there is an innovative new product that is changing that image by Abbott. The proposal is to introduce the FDA-approved over-the-counter Libre Rio, which is a device aimed at adult patients with Type 2 diabetes who do not require insulin to control their condition.

This move is not only another technological update but a massive change in the direction of accessible and real-time glucose monitoring by millions of individuals. Now we will look at how the Libre Rio CGM functions, why it is so unique and how it can revolutionize your everyday routine in managing diabetes.

About Libre Rio:

Ages 18 and over who do not use insulin are the target market for the over-the-counter integrated continuous glucose monitoring (iCGM) gadget called Libre Rio. You run the risk of missing a severe low or high glucose incident if you don’t use Libre Rio according to the label instructions. When making treatment decisions, consider the fingerstick value obtained from a blood glucose meter if readings do not correspond with symptoms or expectations. 

FDA Approved Libre Rio:

Abbott launched an innovative device called Libre Rio, a CGM for persons with Type 2 diabetes who do not apply insulin. The Abbott Libre Rio is FDA-approved to be used in persons with type 2 diabetes who are at a minimum of 18 years old. Adults who control their diabetes by lifestyle changes and do not take insulin are the target market for the over-the-counter CGM. Although Abbott kept the research under wraps, it is now prepared to take on Dexcom, which was approved in March as the first over-the-counter continuous glucose monitor for diabetics who do not use insulin.

Note: The FDA clearance (510(k) K233861) confirms that Libre Rio meets strict accuracy and safety standards under FDA regulation 21 CFR 862.1355. It’s classified as a Class II medical device, cleared for use in non-insulin adults aged 18 and older.

First over-the-counter CGM:

According to Abbott, Rio is the first over-the-counter CGM with a measuring range of 40 to 400 mg/dL that enables the monitoring of exceptionally high or low glucose episodes. Libre Rio will become a part of Abbott’s larger Libre line of CGM devices, which are now utilized by over 60 million individuals worldwide2. The Freestyle Libre 2 and Freestyle Libre 3 systems are part of the Libre group in the United States and are proposed for individuals with Type 1, Type 2, and gestational diabetes. 

Lisa Earnhardt, group president of Abbott’s medical devices division, said in a report that “there is no one-size-fits-all method for glucose monitoring, which is why we’ve intended distinctive products for diverse people — all built on the same world-leading bio wearable technology.” “Some elements are essential for people with diabetes, such as data exchange with healthcare providers or prescription tracking. To maintain their metabolic health, those without diabetes require various elements, such as individualized coaching to encourage practical lifestyle modifications.

Prescriptions are needed for Freestyle Libre systems, and the majority of major U.S. insurance covers them, too. Libre Rio may facilitate the use of a CGM by Americans with diabetes and help them track their progress toward health objectives. It also provides them with info to share with their healthcare doctor when they next officially visit them. 

Components of Libre Rio

Based on the Abbott Freestyle Libre CGM, the system contains a biosensor that is worn on the back of the arm for a maximum of 15 days, and a reader or well-matched smartphone app that shows the user’s blood glucose levels. The Libre Rio has an amount range of 40 mg/dL to 400 mg/dL, allowing for the measurement of very high or low glucose levels. 

Features and Specifications of Libre Rio OTC

Abbott’s Libre Rio Continuous Glucose Monitor integrates innovation and simplicity in one sleek system. Some of the standout features include:

1. Accurate Glucose Range

The Libre Rio sensor measures glucose within a wide 40–400 mg/dL range, helping users monitor both low and high extremes accurately.

2. 15-Day Sensor Wear

Each Libre Rio 15-day sensor provides continuous readings for up to two weeks, minimizing the need for frequent sensor replacements.

3. App Connectivity

Data from the Libre Rio sensor syncs seamlessly with the Libre Rio app, allowing users to check readings anytime. You can view trends, receive alerts, and share reports directly with your healthcare provider.

4. Real-Time Glucose Tracking

Unlike traditional glucose meters, the Libre Rio CGM gives instant insights into your body’s glucose response, providing trend arrows that indicate whether your glucose is rising or falling.

5. Easy-to-Use and Calibration-Free

The system is completely calibration-free—meaning no fingersticks are required for setup or daily use. This feature ensures a hassle-free, user-friendly experience.

Benefits of Libre Rio for Daily Life

For users managing Type 2 diabetes, integrating Libre Rio into daily life can be truly transformative.

Here’s how it enhances everyday diabetes care:

• Freedom from Fingersticks: No more painful or frequent blood tests.
• Better Decision-Making: Real-time glucose data helps you understand the impact of food, exercise, and sleep.
• Improved Motivation: Continuous feedback encourages healthier lifestyle habits.
• Data Sharing: The ability to share readings with healthcare providers makes checkups more productive.
• Convenience: With over-the-counter access, it’s easy to buy and start using immediately.

Users report that the Libre Rio sensor or Freestyle Libre 3 Plus not only simplifies glucose monitoring but also reduces anxiety around blood sugar fluctuations. Having constant visibility into glucose trends brings confidence, peace of mind, and control.

Comparing Libre Rio to Other CGMs

The Libre Rio OTC CGM enters the market alongside competitors like Dexcom Stelo and Abbott Lingo—other consumer-focused devices that also received FDA clearance.

While the Dexcom Stelo shares a similar over-the-counter classification, the Libre Rio focuses specifically on Type 2 diabetes management. Meanwhile, Lingo is targeted toward wellness tracking rather than clinical diabetes management.

Here’s how Libre Rio differentiates itself:

• Accuracy: Built on the trusted FreeStyle Libre technology used by millions worldwide.
• Ease of Access: Available without a prescription, making it more accessible than other iCGMs.
• Wear Duration: Offers up to 15 days of continuous glucose tracking.
• Affordability: Expected to be one of the most cost-effective options in the OTC CGM market.

These advantages position Libre Rio as a leader in the next generation of consumer CGM devices.

Conclusion: 

Diabetes is among the highest public health challenges in the U.S., with almost 38.4 million people living with the disorder. Freestyle Libre systems have been accessible over the counter in more than 50 countries over the previous decade; but, in the U.S., they have only been accessible through prescription. 

Libre Rio may make it easier for Americans with diabetes to try a CGM and start to see advancement in their health goals, allowing them with info to confer with their healthcare provider at their succeeding visit.