The FDA approved the first factory-calibrated personal continuous glucose monitor, manufactured by Abbott Diabetes Care.
Diabetic patients typically have to prick their fingers multiple times per day to test a blood sample or to calibrate their monitoring device. Abbott’s FreeStyle Libre Flash glucose monitoring system is the first device of its kind that does not require fingersticks for calibration or testing.
Users wear a sensor on their arm that can read glucose levels for up to 10 days.
The company pointed to two published clinical trials and real-world evidence that showed users of the FreeStyle Libre system test their glucose levels at least 15 times on average per day, which results in fewer episodes of hypoglycemia or hyperglycemia.
Glucose readings are captured by scanning a hand-held reader over the personal glucose sensor and they can be delivered through clothing.
The system allows diabetic users, who must be at least 18-years-old, and their physicians to identify trends in glucose fluctuations with a visual snapshot, while also avoiding possible interference by acetaminophen — which can falsely elevate glucose readings.
However, the FDA cautioned there may be instances where the FreeStyle Libre system could also provide inaccurate information.
Abbott said the device will be made available by year end at major retail pharmacies.
Read the FDA announcement here: www.fdanews.com/09-28-17-glucose.pdf. — Ana Mulero