The OTC CGM Market: Comparing Stelo, Lingo, & Libre Rio

It has been an exciting few months in the continuous glucose monitoring (CGM) world as three separate over-the-counter devices have now received FDA clearance.

Each of these devices can be purchased without a prescription and with cash—no need for insurance. This novel approach to marketing CGMs opens the door to hundreds of millions of potential new clients as each company targets a different demographic: health-focused individuals, those living with prediabetes, and those with type 2 diabetes who are not taking insulin.

Here, we dive into what each of these OTC CGMs offers, what sets them apart, and how these companies achieved OTC status for devices that have long been prescription only.

A Quick Rundown of Each Product

With all three of these products expected to hit the market in the second half of 2024, there will be some stiff competition in the brand-new field of OTC CGMs. Before we get into the specifications and differences between these devices, let’s take a quick look at who’s launching each and what we can expect.

Stelo

Stelo, created by Dexcom, was the first of these sensors to receive OTC approval from the FDA. This small, completely disposable device uses the same hardware as the Dexcom G7. The main difference between it and the prescription-only device is the software that pairs with it. While the sensor has the same capabilities as the one marketed for people on insulin therapy, the OTC software restricts much of this functionality.

Lingo

The first of Abbott’s OTC CGMs to receive approval is Lingo. This small, disposable sensor uses the same hardware and housing as the Freestyle Libre 3. Like Stelo, the software system is where the real differences exist. Many of the capabilities have been restricted and the mobile app itself has been designed to incorporate multiple additional health-related inputs to allow users to track how diet, exercise, and more affect blood sugar.

Libre Rio

Abbott’s second OTC CGM is Libre Rio. This sensor looks identical to the Lingo and Freestyle Libre 3. The main difference is in the marketing of this new cash-option product. Where Lingo’s software has been designed for healthy individuals wanting to get a better picture of their blood sugar trends, the Libre Rio is made for people living with prediabetes and those with type 2 diabetes who do not use insulin therapy. 

Comparing Specifications

Both Stelo and Lingo have tentative launch dates of “summer 2024,” though neither has hit the market yet. The timeframe for the Libre Rio is less clear, though there is some indication it will be available before the end of the year.

For consumers considering one of these OTC options and for MedTech companies hoping to compete in this quickly expanding market, here is a comparison of the specifications and features of each of these three OTC CGM options.

*Not advertised. Metric based on Freestyle Libre 3 system.

The Key Difference: Marketing

With a few notable exceptions, these three over-the-counter continuous glucose monitors are fairly similar. One aspect that does differ, however, is who they are marketed for.

Both Stelo and Libre Rio are targeting consumers who have type 2 diabetes but are not using insulin. In most cases, these people are able to get a CGM prescription through their doctor. However, this may not be an option if their insurance refuses to cover it, which is still a common problem within this demographic. 

An OTC option allows these people to take advantage of the proven benefits of managing type 2 diabetes with a CGM without having to fight insurance to get one. And without having to pay the exorbitant price of most prescription CGMs. Of course, none of the companies have released information on the expected retail price of these devices, so we can only hope this will be true.

Lingo, on the other hand, is marketed for non-diabetics. Their main focus appears to be health-conscious people, such as those who have gravitated toward services like Signos and Nutrisense. These CGM-based health apps require a medical consult before beginning so that the participant can get a prescription for their CGM. Lingo means to bypass this process and provide both the sensors and the health app directly to the consumer.

Dexcom says they plan to use a direct distribution model and sell Stelo only from their website, at least in the beginning. They hope this will help them better track utilization to improve on the model as needed. Abbott has used a similar approach to OTC CGMs in other countries and will likely follow the same path in the US. 

How CGMs Attain OTC Designation

Neither Dexcom nor Abbott had to create new CGM sensors to reach OTC approval. In fact, both are using sensors currently available with a prescription. It’s the software that pairs with the sensors that has changed and allowed these devices to be available without a prescription.

From the algorithms that interpret the data collected by the sensors to the way that information is presented on the screen, the software these systems use is much different than what the current options rely on. The most notable difference is that none of these sensors or their apps do anything that might put the user at risk.

While still technically medical mobile applications that are subject to FDA regulation, the understood risks of these systems are low enough that the FDA has deemed them safe and effective without a doctor’s prescription. What makes them less risky has a lot to do with what these systems don’t offer that Rx systems do.

Specifically, OTC systems:

• Do not have alarms or alerts
• Cannot be calibrated
• Do not make medication adjustment recommendations
• Typically have tighter blood sugar reporting ranges
• Can have longer wear times since medication therapy is not reliant on accuracy
• Are not compatible with EHR systems
• Do not integrate with multiple devices
• Provide only basic trend information
• Are not intended to manage or treat any condition

If you’re interested in turning your prescription device into an OTC offering, Sequenex can help. We have decades of experience and knowledge developing software for medical devices and working with the FDA to reach our clients’ goals, whatever they may be. Connect with us today to find out what we can do for your diabetes or connected device company.