FDA approves Abbott’s blood glucose monitoring device


The U.S. Food and Drug Administration on Wednesday 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 using a small sensor wire in a ‘sticker’ that is inserted below the skin to continuously measure and monitor glucose levels. 

People with diabetes must regularly test and monitor their blood sugar to make sure it is at an appropriate level, which is often done multiple times per day by taking a fingerstick sample and testing it with a blood glucose meter.

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Abbott's FreeStyle Libre Flash uses a small sensor wire in a 'sticker' that is inserted below the skin to continuously measure and monitor glucose levels.

Abbott's FreeStyle Libre Flash uses a small sensor wire in a 'sticker' that is inserted below the skin to continuously measure and monitor glucose levels.

Abbott’s FreeStyle Libre Flash uses a small sensor wire in a ‘sticker’ that is inserted below the skin to continuously measure and monitor glucose levels.

DIABETES EPIDEMIC

According to the Centers for Disease Control and Prevention, more than 29 million people in the U.S. have diabetes. 

People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). 

When the body doesn’t have enough insulin or cannot use it effectively, sugar builds up in the blood. 

High blood sugar levels can lead to heart disease; stroke; blindness; kidney failure; and amputation of toes, feet or legs. 

The device can be worn for up to 10 days.

‘The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,’ said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. 

‘This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.’ 

Chicago-based Abbott’s shares were trading up about 2 percent at $53.25 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 calibration two to four times a day for optimal accuracy.

HOW THE SYSTEM WORKS

Abbott’s FreeStyle Libre system measures glucose levels through a small sensor applied to the back of your upper arm. 

The sensor, which is the size of two stacked quarters, provides real-time glucose readings for up to 10 days, both day and night. 

The sensor can also read glucose levels through clothes, making testing discreet and convenient.

The FreeStyle Libre system provides people with diabetes three key pieces of data with each scan: a real-time glucose result, an 8-hour historical trend, and a trend arrow showing the direction their glucose is going.

 

DexCom’s shares were down 14.4 percent at $57.78, 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 calibrations to ensure its accuracy.

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.

  

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