Company Reports Accuracy of MyGlucoHealth Meters Consistently
Exceed International Requirements
August 21, 2009 – San Diego — Entra Health Systems, an international applied health care technology company today addressed a recent issue within the healthcare community over the accuracy of self-monitoring blood glucose devices (SMBG). Several groups in health care have voiced concerns that the prevailing international accuracy standard for SMBG’s of plus or minus 20% is insufficient to ensure the safety of diabetic patients using these devices to monitor their blood sugar levels. Richard C. Strobridge, CEO of Entra Health directly addressed these issues as they relate to the recently introduced MyGlucoHealth meter and integrated online telehealth technology.
“We are concerned about the extremely variable nature of glucometers and testing strips that are on the market today,” said Strobridge. “Patient health and safety are of utmost importance to us. By design, the MyGlucoHealth meter and strip system offers high levels of accuracy, with a smaller blood sample size, and faster reading. When tested against calibrated laboratory instruments, the MyGlucoHealth meter meets higher performance standards when compared to many off-the-shelf glucometers. In glucose concentrations of less than 75 mg/dl, MyGlucoHealth tested within plus or minus 6.5% of laboratory calibration, 89% of the time and within 7.5%, 100% of the time. When testing concentrations of greater than 75 mg/dl, MyGlucoHealth was within 5%, 65% of the time, within 10%, 92% of the time and within 15%, 98% of the time.”
“MyGlucoHealth is based on a highly accurate technology using test strips that employ a new biosensor composed of electrochemical components that requires only an extremely small volume of blood (.3µL) to achieve a precise measurement,” Strobridge added. “In addition, our meters are plasma calibrated to allow easy comparison of results with laboratory methods. By integrating a highly accurate glucometer with direct Bluetooth® communication, MyGlucoHealth offers patients an alternative that provides real-time information to more directly control individual patient care, as well as provide clear lines of communication with clinicians and caregivers.”
MyGlucoHealth has never employed glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) glucose monitoring technology in its test strips. The U. S. Food and Drug Administration (FDA) issued Advice for Diabetic Patients on August 13, 2009, stating that blood glucose meters that use GDH-PQQ technology may “produce a falsely high (elevated) blood glucose result.