The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks.

The self-applied sensor measures glucose levels every minute without requiring any finger sticks and can be worn for up to 14 days, the longest time for any similar device. The quarter-sized sensor is worn on the back of the upper arm. Patients use a hand-held scanner to see their glucose levels, the direction of change, and eight-hour history.

The Libre 2 will sell for the same price as the first generation Libre or about one-third as much as other continuous glucose monitors, according to the Abbott Park, Ill.-based company.

That price differential is significant for diabetics, who face increasing challenges in affording insulin and other care.

"Managing diabetes is expensive, even for those with insurance coverage, and in today’s environment it’s even more challenging,” said Jared Watkins, Abbott’s senior vice president for Diabetes Care. “Abbott’s approach since the start has been to make Freestyle Libre affordable and accessible. Even with enhanced features, we priced Freestyle Libre 2 the same as the original version, and significantly less than other CGMs, so people with diabetes who need it can access it.”

The original Libre transformed the glucose monitoring business in 2017 as the first device to be approved to replace blood glucose monitoring in adults.

The second-generation version adds several new features.

The Libre 2 is the “only iCGM available with customizable, optional real-time alarms to alert users when their glucose is too high or low without scanning,” Marc Taub, divisional vice president of technical operation for Abbott’s diabetes business told BioWorld.

In addition, it offers “excellent accuracy and reliable alarm performance, including when glucose levels are very low for both adults and children, giving parents peace of mind,” Taub said.

The mean absolute relative difference for Libre 2 overall is 9.3% compared to 9.8% for Dexcom’s G6 device and 9.4% for the Libre 1, according to Abbott.

The indication for use in children is also new.

“Innovations like Freestyle Libre 2 will change the way people manage their diabetes, especially among children," said Larry Kurt Midyett, pediatric endocrinologist, Midwest Women's and Children's Specialty Group. "Using this technology can improve time in optimal glucose range and lower HbA1c because we can get a full picture of what a child's glucose levels are doing without having to disrupt their play or sleep with painful fingersticks. The alarms are a bonus because they provide parents a level of reassurance."

It also has markedly improved sensitivity.

“Perhaps the biggest surprise to us is Libre 2’s improved accuracy in the hypo ranges (below 70 mg/dl) and accuracy of real-time alerts that stack up, at least on paper, well against Dexcom’s G6 data,” said Margaret Kaczor of William Blair Equity Research.

Kaczor noted that Abbott had considered the accuracy and alerts competitive weaknesses in the previous model’s position in the type 1 diabetes market.

“Libre 2’s FDA approval contains a warning against use with closed-loop pump systems, though we believe Abbott is working closely with both the FDA and pump partners for eventual approval and integration into advanced pump systems,” she added. “We would not overplay this limitation since the company has been highly successful without it.”

The other notable weakness in the Libre 2 at this point is the lack of a corresponding smartphone app.

“The Freestyle Libre 2 is designed to be compatible with mobile apps, which we are working to bring to the U.S. market as soon as possible,” Taub said.

The financial impact

The clearance could significantly help Abbott, according to Joshua Jennings of Cowen Research.

“We think Libre 2 will have a very smooth and successful launch in the coming weeks,” Jennings said.
“We also believe Libre 2 can be efficiently incorporated into coverage plans for U.S. patients, and given the system's high degree of accuracy, should prompt new instances of "preferred status" recognition.

Abbott and its competitors have plenty of room to grow in the market, with just 32% of intensively managed diabetics currently using a CGM of any sort at the end of 2019, Kaczor noted.

Even more significant, data presented at this weekend’s American Diabetes Association 80th Scientific Sessions demonstrated that use of CGM devices reduced HbA1c and increased the amount of time-in-range for both type 1 and type 2 diabetics, whether intensively managed or not, Kaczor reported. That could lead to greater adoption of the devices for type 2 diabetics, who form 90% to 95% of the more than 34 million Americans with diabetes, a potentially massive increase in the iCGM market.

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