FDA Approves New Continuous Glucose Monitoring System for Diabetes

The FDA has approved a new continuous glucose monitoring (CGM) system designed to provide health care professionals with clear, visual snapshots of glucose levels, trends, and patterns in patients with diabetes at a lower cost than other CGM devices on the market.

Abbott’s FreeStyle Libre Pro works with a small, round sensor that is placed on the back of a patient’s arm. The sensor, which is water-resistant and disposable, is held in place with a self-adhesive pad and remains on the back of the arm for 14 days. The patient does not need to interact with the device or draw blood via fingerstick to calibrate the sensor.

“FreeStyle Libre Pro transforms how doctors assess their patients’ diabetes,” said Jared Watkin, senior vice president of diabetes care for Abbott, in a press release. “This novel technology provides a solution to the ongoing challenge of the need for complete and dependable glucose data. This data is imperative for not only the doctor, but also for the patient to help them achieve optimal health.”

The system provides patients and physicians with an ambulatory glucose profile (AGP) that visually charts glucose trends over the course of 14 days. The AGP report helps indicate when a patient is out of glucose range and provides hypoglycemic and hyperglycemic trends and patterns. Patients can also self-monitor their glucose levels by scanning a reader over their sensor to retrieve a reading.