Freestyle Libre Pro Receives FDA Approval

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Last Updated on April 24, 2024

On September 23, Abbott, the global healthcare company, announced that the U.S. Food and Drug Administration (FDA) gave approval for the FreeStyle Libre Pro flash glucose monitoring system. The FreeStyle Libre Pro system is a a “professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes”. It is designed to enable healthcare professionals to provide higher quality diabetes management for diabetes patients.

The FreeStyle Libre Pro system is applied to patients by doctors. The physician applies a small, round sensor on the back of the patient’s upper arm. The sensor, which is water-resistant and disposable, is secured on the arm with a self-adhesive pad and stays on the back of the arm for up to 14 days. This system doesn’t require any patient interaction with the device. Also, the patient is no longer required to draw blood through a fingerstick to calibrate the sensor.

The sensor measures glucose nonstop in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is placed just under the skin. It records glucose levels every 15 minutes, taking up to 1,340 glucose results for up to 2 weeks. This gives the patient’s doctor extensive data for a complete glycemic profile of their patient. After 14 days, the patient returns to the physician’s office, where he/she uses a FreeStyle Libre Pro reader to scan the sensor and download the 14-days’ worth of glucose results that are stored in it (in as little as five seconds).

Abbott’s FreeStyle Libre Pro system is advantageous to both the doctor and the patient. It lowers equipment costs, maintenance and time. The FreeStyle Libre Pro system costs substantially less than other professional CGM products on the market. The physician’s’ office only needs to buy one FreeStyle Libre Pro reader for the office, and it can scan multiple sensors. An Abbott spokesperson said that the reader costs $65 and each sensor is $60.