FDA Approves System of Continuous Glucose Monitoring by Abbott

The U.S. Food and Drug Administration, in what is being called a milestone for management of diabetes, approved the Abbott FreeStyle Libre Flash a continuous glucose monitoring system not requiring any painful pricks using finger sticks.

Rather that diabetes sufferers pricking their finger in order to draw blood samples for reading, the new device uses a tiny sensor wire that is inserted below the surface of the skin that measures and monitors continuously glucose levels.

Users receive their blood glucose reading through waving a reader above the embedded sensor wire. Once users have completed a startup of 12 hours, the device is able to worn for as long as 10 days.

Users are able to get a sense of shifting glucose levels in the blood daily through using the device. It can help to guide the user if concerned about veering too near low or high blood sugar.

Although this system has been available across 40 countries it was not yet approved in the United States. The new FreeStyle Libre will be sold in pharmacies before the end of 2017, said the Abbott news release that followed the device’s approval.

Many analysts have called the approval of the device a complete game changer. The news undercut as well the share price of DexCom which dropped by 16% on Wednesday as Abbott’s move higher by 3%.

An analyst with a Wall Street firm said people do not like pricking their fingers and will give up some accuracy for the ease the device will give them.

Although DexCom was actually the first to be approved by the FDA for a monitor that is continuous with last year’s G5 model, but it still required pricks to the finger to calibrate it.

This approval also has other implications for a deal Abbott has with Bigfoot Medical. That agreement integrates Abbott’s CGM technology with the insulin delivery solutions of Bigfoot in the United States. Their goal is to produce personalized systems that optimize delivery of insulin.

Diabetes affects more than 30.5 million people in the U.S., indicates a report from 2015 by the Center for Disease Control. One of the benefits from continuous glucose monitors is they are able to make it much easier for people that have diabetes to remain on their care plan through making the monitoring process of the levels of blood-glucose a more painless exercise.

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