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FDA approves first under-skin continuous glucose monitoring system

The first system that monitors blood glucose levels without the need to take blood has been approved by the US Food and Drug Administration (FDA).

The FreeStyle Libre Flash Glucose Monitoring System is the first continuous glucose monitoring system that can be used by adult patients to make decisions about their diabetes treatment without having to use a blood sample from the fingertip — often referred to as a ‘fingerstick’.

The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Patients can determine glucose levels by waving a dedicated mobile reader above the sensor wire to determine if glucose levels are too high or too low, and how glucose levels are changing. It can be used only in adult diabetes patients, and after an initial 12-hour start-up period, it can be worn for up to 10 days.

Donald St Pierre, deputy director of new product evaluation at the FDA’s Center for Devices and Radiological Health said: “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.”

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 metre. Using the new system eliminates the need to use a fingerstick.

The FDA warned that risks associated with use of the monitoring system could include hypoglycemia or hyperglycemia in cases where information provided by the device was inaccurate and used to make treatment decisions, as well as the risk of mild skin irritations around the insertion site. The FDA also said that the newly approved system did not provide real-time alerts or alarms in the absence of a user-initiated action — it cannot, for example, alert users to low blood glucose levels while they are asleep.

The monitoring system is manufactured by Abbott Diabetes Care.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203652

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