FDA approves FreeStyle Libre Pro system professional diagnostic for Type 1 and 2 diabetes- Abbott

Abbott announced that the FDA has approved the company's FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring (CGM) system for healthcare professionals to use with their patients with diabetes. Abbott's FreeStyle Libre Pro system is applied to patients by healthcare professionals in a clinic setting. A healthcare professional applies a small, round sensor on the back of the patient's upper arm. The water-resistant and disposable sensor is held in place with a self-adhesive pad and remains on the back of the arm for up to 14 days, requiring no patient interaction with the device or the need for the patient to draw blood via a fingerstick to calibrate the sensor.

The sensor continuously measures glucose in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin. It records glucose levels every 15 minutes, capturing up to 1340 glucose results for up to 14 days, giving the treating doctor comprehensive data for a complete glycemic profile of their patient. After 14 days, the patient returns to the doctor's office, where the doctor uses a FreeStyle Libre Pro reader to scan the sensor and download the 14-days' worth of glucose results that are stored in the sensor � in as little as five seconds.

Comment: The FreeStyle Libre Pro system is the professional use version of Libre System. Abbott recently submitted the consumer version of the FreeStyle Libre system for review by the U.S. Food and Drug Administration. The consumer version of the FreeStyle Libre system is designed to be a continuous glucose monitoring system that does not require fingerstick calibration, and measures glucose levels through a small sensor on the back of the upper arm for up to 14 days. Patients can self-monitor their glucose levels by scanning a reader over the sensor as often as desired to get a reading.