Abbott's (ABT) FreeStyle Libre Pro System Approved by U.S. FDA

September 28, 2016 9:01 AM EDT

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Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (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.

FreeStyle Libre Pro system is designed to empower healthcare professionals to provide better diabetes management for diabetes patients. The system provides healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), giving a more simplified and clear overview of not only glucose levels, but also patterns and trends within those levels. This valuable information helps healthcare professionals make better, customized treatment decisions for their patients – and for a significantly lower cost than other professional CGM products availablei.

On nearly a daily basis, Eugene E. Wright, Jr., M.D. of Duke Southern Regional Area Health Education Center in Fayetteville, N.C., finds it challenging to effectively treat his patients with diabetes when it comes to decisions around insulin, nutrition and medication. "My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels."

"FreeStyle Libre Pro transforms how doctors assess their patients' diabetes," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "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 FreeStyle Libre Pro System—How it Works

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-resistantii 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.

Abbott's FreeStyle Libre Pro system has a number of key advantages compared to other professional CGM systems, including:

  • Convenient for both the doctor and the patient. With the FreeStyle Libre Pro system there is no requirement for fingerstick calibration so patients do not need to be trained by their healthcare professional on calibration. After the sensor is applied to the patient, there is no requirement for the patient to interact with the system.
  • Provides reliable glucose data. Healthcare professionals receive up to 14 days of continuous glucose data based on uninterrupted, normal daily routines of their patients.
  • Reduce equipment costs, maintenance and time. FreeStyle Libre Pro system costs significantly less than other professional CGM products on the marketi. The doctor's office only needs to purchase one FreeStyle Libre Pro reader for multiple patients without having to spend on extra recorders, receivers and transmitters, or devote time to routine disinfecting or recharging patient use components. In addition to the glucose sensor, other professional CGM systems require reusable hardware components, such as receivers, transmitters, and recorders that must go home with each patient to perform the professional CGM assessment.

Ambulatory Glucose Profile—a Complete Glycemic Profile

The FreeStyle Libre Pro system provides patients and their physicians with an Ambulatory Glucose Profile (AGP), a report developed by the International Diabetes Center that is presented in a single, user-friendly, visual chart providing healthcare professionals a complete glycemic view of their patients' glucose trends for up to 14 days.

The AGP report helps identify when a patient is out of glucose range, and provides hypoglycemic and hyperglycemic trends and patterns. These insights help facilitate more meaningful discussions between a doctor and the patient.

Dr. Wright added, "This technology is groundbreaking because continuous glucose monitoring systems for professional use have been long considered a niche, cumbersome, and expensive technology for mostly Type 1 patients. The FreeStyle Libre Pro system changes this paradigm not only because of the unique technology but because it doesn't require fingerstick calibration, is easier to use, more affordable, and is more accessible to people with diabetes."

The FreeStyle Libre Pro system is part of Abbott's FreeStyle family of products including the sensing technology for consumers, the FreeStyle 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.

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