資料來源:https://www.reuters.com/article/us-abbott-fda-diabetes/fda-approves-abbotts-blood-glucose-monitoring-device-idUSKCN1C2352
The U.S. Food and Drug Administration said it approved Abbott Laboratories’ glucose monitoring device for adults with diabetes, allowing millions of people to track their blood sugar levels without having to prick their fingers.
Abbott's FreeStyle Libre Flash reduces the need for fingerstick testing, which is painful and inconvenient, by inserting a small sensor wire below the skin to continuously measure and monitor glucose levels. The device can be worn for up to 10 days.
Chicago-based Abbott’s shares were trading up 3.6 percent at $54 after the bell on Wednesday.
Traditionally, diabetes patients measured their glucose levels nearly a dozen times a day by pricking their finger tips for blood samples.
Nowadays, advanced continuous glucose monitoring devices, such as DexCom Inc’s G5 Mobile and Medtronic Plc’s iPRO2 Professional, which have sensors to measure glucose readings are used. However, these devices require fingertip testing two to four times a day for optimal accuracy.
DexCom’s shares were down 14.3 percent at $57.85, while Medtronic’s stock rose marginally in after-market trading.
Most diabetes patients do not measure glucose as often as they should because of the discomfort caused by these kinds of tests, Jared Watkin, senior vice president of Abbott’s Diabetes Care unit, told Reuters.
According to studies, the majority of people with diabetes test glucose levels less than three times a day, Abbott said.
Abbott’s device, however, is a long-lasting glucose sensor, which does not require fingerstick testing to ensure its accuracy.
The company plans to launch the device before the end of this year, Watkin said on Wednesday.
Abbott already has a continuous glucose monitoring device called FreeStyle Libre Pro in the United States, which helps measure patients’ glucose levels for up to 14 days, but requires a physician’s assistance.