The FreeStyle Libre system reduces the need for finger-stick testing and, instead, continuously measures glucose levels with a small sensor that is self-applied and is approximately the size of two stacked quarters inserted into the back of the upper arm for up to 14 days.
"The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable," said Donald St Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health, in a statement.
When divided into 20 equally sized groups by scan rate (2542 in each), HbA1c declined from 8% in the cohort reporting the lowest scan rate (4.4 times/day) to 6.7% for those with the highest scan rate (48 times/day).
As scan rates increased, hypoglycemia rates below 70, 55, and 45 mg/dL dropped by 15%, 40%, and 49% (all P For the US approval, the FDA evaluated data from a clinical study of individuals aged 18 or older with diabetes and compared readings obtained by the FreeStyle Libre with those obtained by an established laboratory method used for analysis of blood glucose.
"At the end of the day, it's a question as to how you see Libre — whether it's just a modern way of doing blood glucose monitoring or a 'cheaper' CGM," he added.