The U.S. Food and Drug Administration (FDA) has approved the FreeStyle Libre Flash Glucose Monitoring System for use by adult patients with diabetes.
This is the first continuous glucose monitoring system geared to patients and does not require finger-stick calibration.
Last year the FDA approved the professional version of the system, to be used by clinicians for monitoring glucose in patients with diabetes.
Both systems are manufactured by Abbott.
The FreeStyle Libre system reduces the need for fingerstick testing and instead, continuously measures glucose levels with a small sensor that is inserted into the back of the upper arm for up to 14 days. Users then wave a dedicated, mobile scanner over the sensor to obtain readings. The device is intended for individuals 18 years and older.
It is similar to conventional continuous glucose monitors (CGM) in that it measures interstitial fluid glucose levels in real time. But the FreeStyle Libre offers certain advantages, such as longer sensor wear, no requirement for calibration, and lower cost. Also in contrast to current CGMs, the device is factory-calibrated so it doesn’t require finger-stick blood glucose measurements for calibration.
However, it does not have an alarm for users for low and high glucose values, a feature available in CGM systems.
“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, in a statement
“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,” he added.
The FreeStyle Libre system is already being widely used outside of the U.S. It was licensed in Europe in 2014 and is currently available in over 30 countries and being used by more than 250,000 people living with diabetes.
Real World Data Shows Benefits
Recent “real world” data presented earlier this year at the Advanced Technologies and Treatment for Diabetes (ATTD) 2017 Congress showed that use of the FreeStyle Libre led to improved glycemic control.
The study looked at 400 million individual glucose measurements from 50,831 FreeStyle Libre users, for a total of 279,446 sensor readings. Overall, an average of 16.3 scans were performed each day. When divided into 20 equally sized groups by scan rate (2542 in each), HbA 1c declined from 8% in the cohort reporting the lowest scan rate (4.4 times/day) to 6.7% for those with the highest scan rate (48 times/day).
As scan rates increased, hypoglycemia rates below 70, 55, and 45 mg/dL dropped by 15%, 40%, and 49% (all P < .001).
At the time these data were presented, David T Ahn, MD, an endocrinologist and diabetes technology expert at the University of California, Los Angeles, who was not involved in the FreeStyle Libre trials, told Medscape Medical News that he found it “fascinating” that people are checking their sugars 16 times a day, “which is unheard of.”
“That shows that if you remove a barrier to viewing your blood glucose, patients are more than willing to learn more about their diabetes and get a better sense of where things are….They’re not lying when they say finger sticking hurts or is inconvenient,” said Dr. Ahn.
For the US approval, the FDA evaluated data from a clinical study of individuals aged 18 and older with diabetes, and compared readings obtained by the FreeStyle Libre with those obtained by an established laboratory method used for analysis of blood glucose.
Associated risks of using this device might include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions, and mild skin irritations around the insertion site. The FDA notes that it does not provide real-time alerts or alarms in the absence of a user-initiated action
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