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Abbott's Bluetooth-Enabled Glucose Monitor Finally Clears FDA Hurdle

By Cory Renauer – Jun 15, 2020 at 10:25AM

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The company's second-generation integrated continuous glucose monitoring system, the Freestyle Libre 2, earned regulatory in Europe over two years ago.

The most popular constant glucose monitor in America is getting a long-awaited upgrade. The FDA has finally cleared the FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system from Abbott (ABT 2.85%) for type 1 diabetes patients 4 and older.

It has been more than two years since the next-generation iCGM earned CE Mark clearance in Europe, but Abbott's experience with U.S. regulators wasn't nearly as smooth. The FreeStyle Libre 2 adds Bluetooth capability; the Libre 1 model could only transmit information about a patient's blood sugar levels wirelessly using NFC (near-field communication) protocols.

FDA approved stamp

Image source: Getty Images.

Over the past couple of years, another iCGM, the G6 from Dexcom (DXCM 5.51%), has gained significant popularity, partly because its Bluetooth functionality makes it easier for patients (and their caregivers) to receive alerts on their smartphones the moment their blood sugar reaches a dangerous level.

Why diabetes patients may favor the Freestyle Libre 2

Insurers and government payers have quickly learned that replacing frequent finger-pokes with disposable, stick-on glucose monitors improves diabetes patients' outcomes and reduces their hospitalizations. During the first three months of 2020, worldwide Libre sales rose 59.3% year over year to more than $600 million, which works out to around 20% of Abbott's total revenue at the moment.

Despite the fact that the Libre 1 was less able to interact with popular mobile devices, Abbott hasn't had any trouble holding onto a large share of the U.S. iCGM market with its low-priced device. And given that the Libre 2's sensor has been approved to remain applied to patients for 14 days at a time, its new iCGM could have a leg up on Dexcom's G6 and its 10-day sensor. 

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool recommends DexCom. The Motley Fool has a disclosure policy.

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Abbott Laboratories Stock Quote
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