ECL - DexCom Abbott to Launch First FDA Cleared OTC CGMs | Benzinga
DexCom Inc. (NASDAQ: DXCM) and Abbott Laboratories (NYSE: ABT) are likely to launch their first over-the-counter (OTC) continuous glucose monitors (CGMs) in the coming months of 2024.
Dexcom's Stelo and Abbott's Lingo & Libre Rio received FDA clearance in March and June this year, respectively, and now they are up for launch in the coming months of 2024. These devices use the same hardware as past CGMs but are intended for people who do not take insulin.
The new devices are likely to allow the companies to reach about 25 million people in the United States with Type 2 diabetes who do not take insulin, 15 million people who have been diagnosed with pre-diabetes and an estimated 85 million people who have undiagnosed pre-diabetes. This represents a significant market opportunity for both companies.
More on the Launch
With Stelo CGM, Dexcom is likely to target people with Type 2 diabetes who do not take insulin. However, Stelo can also be used by non-diabetic people, thanks to a broad label from the FDA. Abbott, on the other hand, will split its OTC CGM into two sensors: Lingo, which is intended for people who do not have diabetes, and Libre Rio, which will compete more directly with Dexcom for Type 2, non-insulin users.
Abbott is offering two different OTC CGMs as the company believes that "there's no one size fits all approach to managing care." Per the company, people living with diabetes might want features for insulin management, medication tracking and sharing data with a provider or caregiver. However, Dexcom's Stelo is the only OTC CGM that is intended for people with Type 2 diabetes. The company expects that a large number of non-diabetic people will try the device.
Dexcom is likely to plan a late August launch of its Stelo sensor. The company is looking forward to first selling the device online, which can prove beneficial for the company to learn more about users and their buying patterns. Abbott also intends to launch an e-commerce website this summer to offer its wellness-focused Lingo device. The company has not yet revealed any schedule for Libre Rio.
On the pricing front, both companies have ...