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 Me