FDA approves first continuous glucose monitoring system for
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The first continuous glucose monitoring system- FreeStyle Libre Flash Glucose Monitoring System- has received the US FDA approval. This system can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”)

The system uses a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels thus reducing the need of fingerstick testing. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire. The target users are the18 years or above aged diabetic patients and it can be used after a 12-hour start-up period and be worn for up to 10 days.

Before approving this system, the FDA evaluated data from a clinical study of individuals aged 18 and older with diabetes, and reviewed the device’s performance by comparing readings obtained by the FreeStyle Libre Glucose Monitoring System to those obtained by an established laboratory method used for analysis of blood glucose.

While it does have its advantages, it lacks in the following areas:

- Hypoglycemia or hyperglycemia can occur if the information provided by the device is inaccurate and is used to make treatment decisions

- Mild skin irritations around the insertion site

- No real-time alerts or alarms in the absence of a user-initiated action...

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm
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Dr. R●●●●●i R●●●●●●l A●●●●●t
Dr. R●●●●●i R●●●●●●l A●●●●●t Family Medicine
NICE
Sep 30, 2017Like