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FDA approves Freestyle Libre Pro CGM system
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The FDA has approved Abbott’s FreeStyle Libre Pro, a continuous glucose monitoring system for health care providers to use with their patients with diabetes, the company announced in a press release.
The FreeStyle Libre Pro system is part of Abbott's FreeStyle family of products, including the sensing technology for consumers, the FreeStyle Libre system. The sensor continuously measures glucose in interstitial fluid through a small (5 mm long, 0.4 mm wide) filament that is inserted just under the skin. The device records glucose levels every 15 minutes, capturing up to 1,340 glucose results for up to 14 days, giving the treating provider comprehensive data for a complete glycemic profile of the patient.
Abbott recently submitted the consumer version of the FreeStyle Libre system for review by the FDA. The consumer version of the FreeStyle Libre system is designed to be a continuous glucose monitoring system that does not require fingerstick calibration. Patients can self-monitor their glucose levels by scanning a reader over the sensor as often as desired to get a reading.
"FreeStyle Libre Pro transforms how doctors assess their patients' diabetes," Jared Watkin, senior vice president of Diabetes Care, Abbott, said in the statement. "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 will be available for health care providers in the coming weeks, according to the release.