Abbott (NYSE:ABT) touted clinical trial results of its wearable Freestyle Libre glucose monitor at the annual meeting of the American Diabetes Association in New Orleans. Compared to users of conventional blood glucose monitors that require a finger prick, diabetics on the Libre spent 38% less time in hypoglycemia, the company said.
Patients in the clinical trial wore the Libre for the 1st 2 weeks of the study, but did not have access to the results. When patients gained access to the data via the device’s reader, the amount of time spent in hypoglycemia was reduced by 33%. In addition, patients scanned their sensor an average of 15 times per day.
Abbott says that people with traditional blood glucose monitors test themselves less than 3 times a day due to the pain and inconvenience of finger pricks. The Libre is a small, round sensor worn on the back of the upper arm. A reader is scanned over the sensor to obtain glucose levels, eliminating the need to draw blood, except in certain circumstances, such as when hypoglycaemia or impending hypoglycaemia is reported by the system.
Other findings from the trial include a 50% in hypoglycemia at night among patients on the Libre, as compared to those on traditional monitors. Libre patients also experienced no increase in Hb1Ac levels at 6 months.
The trial was carried out in Austria, Germany, Netherlands, Spain and Sweden.
“Hypoglycemia is the main barrier to attaining optimum glucose control in persons with insulin-treated diabetes. Moreover, hypoglycemic events can not only lead to adverse clinical outcomes including cardiovascular events and death, but they can also incur significant emergency healthcare costs,” said the trial’s chief investigator, Dr. Jan Bolinder of the Karolinska Institutet in Stockholm. “This clinical trial has proven that patients will test more often when they have an easier and more convenient way to do so utilizing a device like FreeStyle Libre, leading them to ultimately being healthier, which is our goal for our patients.”
The device received a CE mark in 2014. It is already available in 11 European countries, as well as Australia and Brazil. A professional-use version, dubbed FreeStyle Libre Pro, is available in India and South Africa.
FDA approval would help turn around the company’s struggling diabetes care unit. It had sales of $243 million in Q1 2016 down 9.1% year-over-year (5.2% on a constant-currency basis). U.S. revenues fell 31.6% to $69 million.
