FDA Approves First Finger Prick-Free Glucose Monitoring Device

The U.S. Food and Drug Administration approved Glucose Monitoring Device for adults, which already is sold in 41 other countries. Abbott Laboratories gained clearance Wednesday to start selling in the U.S. The first continuous glucose monitor that does not require people with diabetes to routinely prick their fingers.

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The device consists of a small sensor, about the size of a quarter, that’s worn on the back of the upper arm to continuously track glucose levels. The sensor, unlike other wearable sensors, does not require patients to prick their fingers for calibration. Patients can place a hand-held reader. The device to see their current glucose levels, trends, patterns and where those levels headed. They can then use those readings to figure out how much insulin to take to manage their diabetes.

The company is not disclosing pricing information until it gets closer to launching the product in the U.S. Likely be before the end of the year, said Abbott spokeswoman Vicky Assardo. But she said in an email the price will be “very similar” to the price in Europe. The reader costs about $69, and each sensor, which lasts about 14 days, also costs about $69, before insurance. In the U.S., the sensor will last about 10 days.

FDA warned device is inaccurate its information used to make treatment decisions

Regional and national health insurance systems in 18 countries including the United Kingdom, France, Germany and Japan already have agreed to fully or partially cover the devices.

In the U.S. continuous glucose monitors often covered by insurance, Watkin said. He said Abbott plans to have discussions about coverage with insurers in the U.S. It is confident it will be able to show them the advantages of covering it.

The device also does not alert patients of low glucose levels without a patient waving the reader over his arm.

Also, the system doesn’t communicate with an insulin pump as other continuous glucose monitors do though Abbott is working with a Silicon Valley-based company on that feature.

The FDA warned in a news release that patients may experience abnormally high or low glucose levels in cases. The information provided by the device inaccurate, and the information used to make treatment decisions.

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Abbott’s Kazemi, however, said Abbott is confident in the device’s accuracy. Patients using the devices to check glucose levels an average of 16 times a day in Europe, the devices already available, he said.