Pharma giant Abbott ($ABT) is gaining more traction for its FreeStyle Libre continous glucose monitoring system with the publication of its Impact clinical trial findings in the journal Lancet.
What’s unique about the FreeStyle Libre system is that doesn't require twice-daily finger sticks for calibration, as most CGMs do.
Results from the study, which were released in June, touted significantly lower hypoglycemia in Type 1 diabetes patients as well as a 40% reduction in the rate of nocturnal hypoglycemia, and a 50% reduction in serious hypoglycemia with no increase in HbA1c at 6 months.
Although the device has held a CE mark for sometime and Abbott remains on the long path toward FDA approval, results of the study being published in what is considered one of the top medical publications in the world can be perceived as professional validation for the study.
“It’s quite an honor,” Dr. Mahmood Kazemi, head of Abbott’s Medical Affairs division, told FierceMedicalDevices. “The ability to publish in such a journal certainly adds to the importance and credibility of the study.”
The 23-site study was conducted in Europe over a 6-month period and included more than 252 patients. It compared the use of the FreeStyle Libre to traditional finger stick-based blood glucose self-monitoring systems.
The study found that HbA1c which is an average measurement of blood glucose levels over 90 days didn’t increase compared to the finger-stick group. Abbott interpreted that result as a sign that the FreeStyle Libre system can safely and successfully replace the need for routine finger sticks. Typically, there is an inverse relationship between the risk of severe hypoglycemia, or low glucose levels, and HbA1c reduction, the company noted in the study.
“From my perspective, what we have now is a technology that is more convenient and more safe for (diabetes) patients,” Kazemi said.
The Freestyle Libre system requires a handheld reader or smartphone to be waved over an adhesive sensor that records glucose data. Earlier this year, Abbott introduced a data-sharing and smartphone app that’s compatiable with the system.
- check out the study results release