FDA Approves New Integrated CGM System From Abbott

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FDA Approves New Integrated CGM System From Abbott

The U.S. Food and Drug Administration (FDA) has approved the latest integrated continuous glucose monitoring (iCGM) system from Abbott, known as the Freestyle Libre 2. This new system features several unique and improved features, including minute-by-minute glucose readings and a sensor that can be worn for 14 days before being replaced. It also boasts excellent alarm performance to alert users to low blood glucose levels, according to the company.

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As noted in a press release from Abbott, the Freestyle Libre 2, like other integrated systems, is designed to work in tandem with other devices such as insulin pumps. It is approved to replace traditional fingerstick blood glucose tests, which means that conformation with a fingerstick is needed only in certain unusual situations — such as when your symptoms don’t seem to match your displayed glucose reading in the event of a “low glucose” alarm.

The sensor for the Freestyle Libre 2, which is about the size of two quarters stacked on one another, is self-applied and worn on the back of your upper arm. This sensor’s performance can be sustained for up to 14 days, and the company touts FDA data showing that no other CGM system maintains a similar level of accuracy over the entire period of wear.

The sensor uses Bluetooth technology to send an alarm signal when your glucose level goes above or below a given threshold. Users can customize these alarms or turn them off. In order to see regular glucose readings, users need to scan the sensor using a handheld readings device, which will then show their real-time reading, a glucose trend arrow, and an eight-hour glucose level history. The system is also designed to communicate with a mobile app from Abbott, which the company has not yet released in the United States but is trying to bring to the market as soon as possible.

Abbott will be rolling out the Freestyle Libre 2 across a participating network of pharmacies and durable medical equipment suppliers in the next few weeks. Pricing and, presumably, insurance coverage for the system will be the same as for the company’s currently available Freestyle Libre 14 day system, which was approved for the U.S. market in July 2018.

The new system is approved for adults and children ages four and above with diabetes. The minute-by-minute reading feature is touted as being especially helpful for children with diabetes, since it ensures a timely reading compared with other CGM devices with a longer interval — and because children tend not to like the disruption that fingerstick-style testing involves. Like other CGM systems, the Freestyle Libre 2 may help doctors look at glucose patterns while a child (or adult) is asleep or otherwise not in a position to take traditional readings.

Affordability is a key selling point for Abbott’s new system, with the company touting its price as being one third as much as most other CGM systems. The price that an end user pays, however, is likely to depend on insurance coverage and other factors.

“Managing diabetes is expensive, even for those with insurance coverage,” says Jared Watkin, senior vice president of Diabetes Care at Abbott, in the press release. “From the start, Abbott designed FreeStyle Libre technology with affordability in mind. We set a global price for our sensing technology that’s closer to that of traditional blood glucose fingerstick systems, and significantly less than other CGMs, because we wanted to make sure our life-changing technology was accessible to as many people as possible.”

The Freestyle Libre 2 is not designed to be used with automated insulin dosing systems, or as part of a closed-loop insulin delivery system. Taking high doses of vitamin C, over 500 milligrams per day, can make sensor readings inaccurately high, Abbott warns in the press release.

Want to learn more about CGM? Read “CGM for Diabetes Management” and “Sensing the Big Picture With Continuous Glucose Monitoring.”

Image: Abbott FreeStyle Libre 2. Courtesy of Abbott.

Quinn Phillips

Quinn Phillips

Quinn Phillips on social media

A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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