|Abbott's FreeStyle Libre Flash glucose monitoring system--Courtesy of Abbott|
Abbott ($ABT) reported the latest data for its FreeStyle Libre system that doesn't require twice-daily finger sticks for calibration, as CGMs typically do. The 6-month randomized, controlled trial was conducted in Europe; it compared the use of the FreeStyle Libre to traditional finger stick-based blood glucose self-monitoring systems. The study found that Libre users reduced time spent in hypoglycemia by more than one-half and cut serious hypoglycemia by half.
Interestingly, HbA1c--an average measurement of blood glucose levels over 90 days--did not increase compared to the finger-stick group, which Abbot takes as a sign that the "the FreeStyle Libre system can safely and successfully replace the need for routine finger sticks." There is typically an inverse relationship between the risk of severe hypoglycemia, or low glucose levels, and HbA1c reduction, the company noted.
"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 study's chief investigator, Dr. Jan Bolinder of the Karolinska Institutet in Stockholm, Sweden, in a statement.
"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," he added. Traditional finger-stick blood glucose monitoring is recommended for at least four to 8 times daily for Type 1 and Type 2 diabetics.
The 23-site study included 252 patients. It found that FreeStyle Libre versus traditional self-monitoring of blood glucose resulted in a 38% reduction of time spent in hypoglycemia, including a 40% reduction of nocturnal hypoglycemia and a 50% reduction in serious hypoglycemia. After 6 months of use, HbA1c did not increase.
Participants using the FreeStyle Libre sensors scanned them an average of 15 times daily. The system requires that a handheld reader or smartphone be waved over the adhesive sensor to record glucose data. Abbott recently introduced data-sharing and smartphone app compatibility for the FreeStyle Libre system. The device has long been CE marked, but the route to an FDA approval remains murky.
"We cannot underestimate the power of knowledge--especially for someone who is managing a chronic condition. Our goal is to help our customers be healthier and live fuller lives, and it's clear from this trial that FreeStyle Libre provides our customers just what they need to do that," said Abbott Diabetes Care SVP Jared Watkin.
- here is the announcement