This is the first continuous glucose monitoring system capable of being used by adult diabetes patients without calibration using a blood sample. Instead, users insert a small sensor wire under the skin, and a wand-like device is waved atop the sensor to report glucose levels.
The small sensor promises to be both painless to apply and easy to wear, and it is water resistant, which means you can keep it on throughout your day. In fact, the FreeStyle Libre sensor is meant to stay on your body for up to 10 days, allowing for continuous glucose monitoring (CGM). The benefit of this method, the FreeStyle team notes, is that it allows for glucose levels to be tracked continuously, which means patients can observe patterns and trends that could result in better diabetes management.
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “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.”
This approval could be a boon for the more than 29 million Americans living with diabetes. In conducting their testing, the FDA reviewed the FreeStyle Libre’s performance by comparing its readings to those from an “established laboratory method used for analysis of blood glucose.” Clearly, these results were comparable to one another. The FDA does note that potential risks include hypoglycemia or hyperglycemia should data be inaccurate (though this is a risk with any such reader), as well as mild skin irritation around the sensor’s insertion site.
The FreeStyle Libre should be coming to a pharmacy near you in the near future, but pricing has yet to be revealed.
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