Approved for use in adults with type 1 and type 2 diabetes
by Kristen Monaco, Staff Writer, MedPage Today September 28, 2017
WASHINGTON — Abbott’s FreeStyle Libre Flash Glucose Monitoring System — the first system that doesn’t require fingerstick calibration — was granted FDA approval.
The decision Wednesday was based off of clinical data from two trials comparing the flash glucose-monitoring system to self-monitoring of blood glucose in type 1 and type 2 diabetes, both of which showed reduced time spent in hypoglycemia for those using the continuous glucose monitoring (CGM) system.
Approved for use in adults with diabetes, the water-resistant device can be worn for up to 10 days, following a 12-hour start-up period. Worn on the back of the upper arm, the sensor wire from the device is placed under the skin to continuously measure blood glucose.
Since the system is factory-calibrated, users don’t have to do the twice-daily fingersticks that most CGMs currently require. Interference with acetaminophen, which may give falsely high glucose readings in other CGMs, is also avoided with this system, Abbott noted.
Both the user and healthcare provider can access daily data on glucose fluctuations and trends in order to make treatment decisions. The American Association of Clinical Endocrinologists has advocated for standardizing this information, using the term “Ambulatory Glucose Profile,” or AGP.
However, some drawbacks to the system include “that it has no alerts for either high or low [blood glucose] levels for patients with hypo unawareness which could be a challenge, and it also requires a separate receiver to view data. Other systems on the market can have data viewed on the smart phone,” noted Carol Levy, MD, director of the Mount Sinai Diabetes Center and director of the Artificial Pancreas Research Program at the Icahn School of Medicine there, in an email to MedPage Today.
“Having more options is always good for patients and since this device will be available in local pharmacies at a reported lower cost, it will likely provide patients with more access to their care,” she added.
Abbott stated the FreeStyle Libre Flash system will be available in the U.S. with a prescription by the end of this year.