FDA Clears Abbott’s Needle-Free CGM For Professional Use

FDA has approved Abbott’s Freestyle Libre Pro System for professional continuous glucose monitoring (CGM), which provides clinicians with 14 days’ worth of patient data so they can make more informed clinical decisions regarding diabetes management. The system does not require finger-stick calibrations and is significantly more affordable than competitive CGM models, stated Abbott.

The FreeStyle Libre Pro sensor is attached to the back of the patient’s upper arm at the doctor’s office. A water-resistant adhesive pad holds the sensor in place and a 5 mm long filament inserted under the skin monitors blood glucose every fifteen minutes for a total of 1340 glucose measurements in 14 days. After two weeks, the patient returns to the doctor’s office, where a clinician scans the sensor with an external reader and downloads the data.

The key advantages of the FreeStyle Libre Pro system, according to Abbott, are its ease of use and reduced equipment costs.  Once the sensor is in place, the patient does not need to interact with it or take home any cumbersome scanning equipment that may require recharging or maintenance. Also, a doctor’s office can purchase one reader and use it to scan multiple patients using the system.

Inconsistent self-monitoring makes ongoing diabetes management difficult, because there are too many gaps in the data, said Eugene Wright, a doctor at the Duke Southern Regional Area Health Education Center. Wright called the new technology a “change to the paradigm,” because it makes professional CGM more accessible and affordable for Type I patients.

While the professional model of the FreeStyle Libre is approved for the U.S., the consumer version of the technology remains under review at the FDA. Earlier this year, Abbott received CE Mark approval for use of the system in children aged 4-17.

In June, Abbott announced positive results from the IMPACT clinical study, which was conducted at over 23 sites in Europe with 252 participants with Type I diabetes. When compared to traditional self-monitoring of blood glucose, participants using the FreeStyle Libre system experienced 33 percent fewer hypoglycemic (low blood glucose) events, 50 percent fewer serious events, and 91 percent fewer finger sticks.

While average diabetic patients testing their own glucose with traditional methods scan three or four times per day, researchers found that patients with the FreeStyle Libre system tested an average of 15 times per day, which correlated with better patient outcomes, said Jan Bolinder, chief investigator of the study at the Karolinska Institute in Stockholm, in a press release.

“The IMPACT trial confirms the importance of empowering people with the data they need to make their own choices, said Jared Watkin, senior VP of Diabetes Care at Abbott. “We cannot underestimate the power of knowledge—especially for someone who is managing a chronic condition.

Abbott recently sold off its ophthalmologic unit to J&J, and is finalizing a $25 billion deal to acquire St. Jude Medical.  In a recent sales call, Abbott CEO Miles White stated that a “steady cadence” of recent product launches and approvals were driving significant growth.

During the call, White projected a U.S. launch for a consumer FreeStyle Libre system by the first quarter of 2017.