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US FDA Clears Abbott’s Continuous Glucose Monitors (Lingo & Libre Rio) for Over-the-Counter Use

US FDA Clears Abbott's Continuous Glucose Monitors for Over-the-Counter Use

The FDA in the United States has approved Abbott’s two continuous glucose monitors for over-the-counter (OTC) usage, the company said on Monday (ABT.N). This important move should improve diabetes management and general health by making cutting-edge glucose monitoring equipment more widely available to a larger variety of customers.

The Cleared Devices

Lingo

Target Market

Intended for customers who are at least 18 years old.

Purpose

The goal of this consumer wearable is to help people who want to get healthier and feel better all around.

Features

To assist customers in understanding their glucose trends and making educated lifestyle decisions, Lingo provides continuous glucose monitoring.

Libre Rio

Target Audience

Adults with Type 2 diabetes who do not use insulin are the target audience.

Purpose

People who primarily control their diabetes with lifestyle changes rather than medication.

Features

Libre Rio allows users to track their blood sugar levels in real time, which makes it easier to control their condition with diet and exercise.

Consequences of OTC Approval

The FDA’s approval of Abbott’s CGM devices for over-the-counter use marks a significant advancement in the treatment of diabetes and health monitoring:

Improved Accessibility

More people can use and benefit from CGM technology without a prescription.

Empowerment

Individuals can monitor and manage their wellness and health more actively.

Simplified Acquisition

Since customers may now buy continuous glucose monitors or CGMs straight from pharmacies and internet merchants, getting one is now quicker and simpler.

In Contrast to Other OTC CGMs

Abbott’s OTC certification comes after the FDA approved Dexcom’s (DXCM.O) Stelo, the first over-the-counter continuous glucose monitor, in March. As the value of continuous glucose monitoring in controlling diabetes and enhancing health outcomes becomes increasingly apparent, there is a trend in making continuous glucose monitors or CGMs more widely available.

Unresolved Queries

Even while the permission is a big start in the right direction, some things are still unclear:

Cost

Abbott has not yet revealed the cost of Libre Rio and Lingo.

Availability

There has been no word on when people will be able to purchase these devices.

Possible Advantages

There are many advantages to continuous glucose monitors or CGMs being available over-the-counter:

Better Health Outcomes

People who receive ongoing monitoring can better control their blood sugar levels, which lowers their chance of developing diabetes-related problems.

Improved Quality of Life

Users can lead healthier lives by making better decisions about their nutrition, exercise routine, and general lifestyle when they have access to real-time data.

More Widespread Adoption

As more people come to understand the importance of continuous glucose monitoring in managing their health, easier availability of CGMs may result in a wider adoption rate.

Explore More Continuous Glucose Monitors in Watches: From Wrist to Well-being

FAQs

Do Abbott’s over-the-counter CGMs work with smartphones?

Yes, a lot of CGMs—including Abbott models—come with complimentary mobile apps that let users view glucose data, analyze trends, and get alerts right on their phones.

Are Abbott’s OTC CGMs simple to use for people who aren’t familiar with CGM technology?

Yes, even people who are unfamiliar with CGM technology can utilize OTC CGMs like Abbott’s Lingo and Libre Rio since they have user-friendly interfaces and clear instructions.

How might CGMs assist in diabetes management?

With the use of real-time glucose readings from CGMs, individuals may continuously check their blood sugar levels. This facilitates decision-making about medicine, nutrition, and exercise and improves diabetes control.

What possible effects on diabetes care might the OTC availability of CGMs have?

By facilitating people’s access to continuous glucose monitoring technology, the over-the-counter availability of CGMs has the potential to greatly enhance diabetes management by improving glycemic control and overall health outcomes.

Which other over-the-counter CGMs have FDA approval?

In March of this year, the FDA approved the OTC use of Dexcom’s Stelo CGM, before Abbott’s Lingo and Libre Rio.

Where can I purchase OTC CGMs from Abbott?

Pharmacies and internet merchants will sell Abbott’s OTC continuous glucose monitors or CGMs; however, the precise locations and dates of availability are still pending.

Does buying Abbott’s OTC CGMs require a prescription?

No, you may buy Abbott’s Lingo and Libre Rio continuous glucose monitors or CGMs over-the-counter without a prescription thanks to the FDA’s OTC clearance.

What advantages do users of OTC CGMs receive?

OTC CGMs come with some advantages, such as improved accessibility, convenience, real-time glucose monitoring, and the capacity to make wise decisions regarding one’s lifestyle and health.

Why does the FDA’s approval of these CGMs for over-the-counter use matter?

The FDA’s approval of over-the-counter use is noteworthy because it makes cutting-edge glucose monitoring technology more widely available, enabling more people to gain from continuous glucose monitoring without a prescription.

What are the continuous glucose monitors for which Abbott has FDA approval to sell them over the counter?

The FDA has approved Abbott’s Lingo and Libre Rio continuous glucose monitors (CGMs) for over-the-counter (OTC) usage.

Can I get Abbott CGMs over-the-counter and have insurance pay for them?

Depending on the provider and plan, insurance coverage for over-the-counter CGMs varies. To find out your possibilities for coverage, it’s best to contact your insurance provider.

How do I set up and operate an Abbott over-the-counter CGM?

Inserting the sensor, connecting it to a compatible device, and following the user manual’s instructions are the usual steps involved in setting up an over-the-counter CGM. The device comes with comprehensive setup instructions.

In Summary

An important step forward in the treatment of diabetes is the FDA’s approval of Abbott’s continuous glucose monitors for over-the-counter usage. This choice might completely change how people manage their health and well-being by lowering the cost of CGM equipment. The implications of this decision will become more apparent as pricing and availability information becomes available, indicating that everyone who requires sophisticated glucose monitoring will eventually have access to it.