Devices & Diagnostics

FDA approves Abbott’s continuous glucose monitoring system, moving beyond painful finger pricks

Although DexCom actually was the first to get FDA approval for a continuous glucose monitor with its G5 model last year, it requires finger sticks to calibrate the device.  

By Stephanie Baum on September 28, 2017

In a milestone for diabetes management, the U.S. Food and Drug Administration gave a green light to Abbott’s FreeStyle Libre Flash continuous glucose monitoring system that doesn’t require painful pricks with finger sticks.

Instead of people having to prick their fingers to get a blood sample for readings, the device uses a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels, according to an Abbott news release. Users get their blood glucose reading by waving a mobile reader above the sensor wire. Once users complete a 12-hour start-up period, the device can be worn for up to 10 days.

Users can get a sense of their shifting blood glucose levels on a daily basis through Abbott’s Ambulatory Glucose Profile. It can help guide users concerned about veering too closely towards low blood sugar or high blood sugar. Although the system has been available in 40 countries, it has not yet been available in the U.S. FreeStyle Libre will be available in pharmacies by the end of the year, the news release said.

A Bloomberg report cited analysts from Jefferies who called the approval a game changer. The news also undercut DexCom’s share price which fell 16 percent yesterday, as Abbott’s inched up by more than 3 percent, according to the article.

“People don’t want to prick their fingers,” Jefferies analyst Raj Denhoy told Bloomberg. “They’re willing to give up some level of accuracy for the ease of the device.”

Although DexCom actually was the first to get FDA approval for a continuous glucose monitor with its G5 model last year, it still required finger sticks to calibrate the device.

The approval also has implications for Abbott’s deal with Bigfoot Medical. The agreement will integrate Abbott’s CGM tech with Bigfoot’s insulin delivery solutions in the U.S. The goal is to produce personalized, systems to optimize insulin delivery.

Dr. Maria Tulpan of Lenox Hill Hospital in New York said in the news release that the system will create more data to better assess the effectiveness of patients’ diet, exercise, and medication and tweak them if necessary.

“What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.”

Diabetes affects 30.4 million in the U.S., according to a 2015 estimate by the Centers for Disease Control. One benefit of continuous glucose monitors is that they can make it easier for people with diabetes to stick to their care plan by making the process of monitoring blood-glucose levels a more passive and painless exercise.