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FDA Cleared Patient Monitoring Wearables

Abbott’s Freestyle Libre 2 Advanced Wearable Glucometer FDA Cleared

After a long wait, the FDA has finally cleared Abbott’s FreeStyle Libre 2 continuous glucose […]

After a long wait, the FDA has finally cleared Abbott’s FreeStyle Libre 2 continuous glucose monitor in the U.S. for any patients with diabetes over four years of age. The system provides low and high glucose level alarms, which let patients know in real-time if they’re falling outside of their normal range and it doesn’t require any fingersticks to calibrate it. Such technology can allow for significant improvements in patient comfort while offering exciting new capabilities for improved glucose management.

The FreeStyle Libre 2 can take blood glucose readings as often as every minute and a single disposable sensor patch can work for two weeks straight. To download measurements and do spot testing, an accompanying smartphone-like reader is simply placed near the sensor for a second to make the automatic transfer happen. If the sensor detects numbers outside of a set range, it can signal the reader to activate an alarm so that the patient or caretaker can take appropriate action to get the glucose back within range.

Patients can apply the patch all on their own and effectively forget about fingersticks, as according to Abbott, the FreeStyle Libre 2 “has a combined mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.3% (9.2% for adults and 9.7% for pediatrics), making it the only iCGM sensor sustaining a high level of accuracy over 14 days.”
“Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children,” said Larry Kurt Midyett, M.D., pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group, in an Abbott press release. “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.”
Product page: FreeStyle Libre 2
Flashbacks: FreeStyle Libre 14 day System: Interview with Chris Thomas, Director of Biosensing Technology, Abbott; Abbott’s New FreeStyle Libre 2 Continuous Glucometer with Level Alarms Cleared in EU; Abbott’s FreeStyle Libre 14 Day Flash Glucose Monitor Approved in U.S.
Via: Abbott

Original Article: (https://www.medgadget.com/2020/06/abbotts-freestyle-libre-2-advanced-wearable-glucometer-fda-cleared.html)

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