FDA Approves 14-Day Continuous Glucose Monitoring System

AUGUST 01, 2018
Kevin Kunzmann
The FDA has approved the FreeStyle Libre 14-day Flash Glucose Monitoring system, now the longest-lasting self-applied continuous glucose monitor (CGM) in the United States market.

The CGM, from Abbott, supplants the company’s 10-day Libre system, which was approved in September 2017 as the first CGM capable of providing adult diabetes patient feedback from a fingertip blood sample.

The FreeStyle Libre system was first launched in Europe in 2014, with clinical and real-world data support showing patients who more frequently scanned blood samples spent less time in hypoglycemia or hyperglycemia while also reporting improved average glucose levels and overall control.

The 14-day system requires a one-hour warmup phase, but with greater accuracy compared to its 10-day preceding model. In clinical trials, patients provided the new CGM reported a mean absolute relative difference (MARD) of 9.4, versus a MARD of 9.7 in those administered the 10-day CGM.

For the full article, visit .