CAESAREA, Israel, March 18, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, today reported that it has concluded a 368 patient user performance study on the Dario. The results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. The accuracy of Dario has proven to surpass other glucose meters and delivers accuracy that exceeds the minimum new stringent guidance of the ISO 15197:2013.
The successful clinical study is an important milestone, it allows the completion of the 510(k) application for Dario and is a significant step towards the Dario anticipated approval and commercialization in the USA.
The comparative, observational, single-arm User Performance Evaluation study was performed in Columbus Ohio, USA and consisted of 368 subjects having Type I or Type II diabetes. The study was conducted using the Dario all-in-one blood glucose monitoring solution indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The objectives of the study were to evaluate the performance of blood glucose levels taken from the Dario meter compared to the industry’s standard references for usability and performance. The study criteria was derived using a combination of the European ISO-15197:2013 In Vitro Diagnostic Test Systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus standard as well as the FDA’s more stringent draft guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use document issued on January 7, 2014.
LabStyle also announced the addition of Mr. Bill McGrail to its management team as VP Regulatory. Mr. McGrail brings to Dario over 25 years of experience in the medical device industry particularly new product development of blood glucose meters and regulatory and quality affairs for clearance and distribution of medical products in the U.S., European Union, Canada and a number of other foreign markets. Mr. McGrail is a valuable strategic addition to the Dario team and will lead and support Dario through the regulatory approval process as well as the anticipated introduction to the US market.
In previous roles, Mr. McGrail served as VP of Research and Development for AgaMatrix Inc., where he was responsible for the design and development of state of the art blood glucose meters. As VP of Regulatory, Quality and Clinical, he was responsible for the worldwide clearance of the blood glucose meters and fully integrated mobile health manager apps.
Erez Raphael, president and chief executive officer of LabStyle Innovations, stated “We are very pleased with the results of this important study. The successful study shows that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and can be a valuable tool to the US diabetic community. Mr. Raphael continued; “We welcome Bill McGrail to our management team. We are confident that his vast experience and knowledge in the area of blood glucose meters, their regulation and global distribution will accelerate our regulatory approval and distribution roadmap.”
