Integrity Applications, Inc., is touting new data demonstrating the clinical performance of GlucoTrack®. The company says the data provides further support for its suitability for people with type 2 diabetes across various medication regimes.
Background
GlucoTrack is a non-invasive device for measuring glucose levels in people with type 2 diabetes and prediabetes. The device rapidly measures and displays an individual’s glucose level in about a minute without finger pricking or any pain. GlucoTrack features a small sensor that clips to the earlobe and measures the user’s glucose level using innovative and patented sensor technology. The device, while CE marked in Europe, remains experimental in the United States, Integrity expecting to begin clinical trials for FDA approval in late 2017.
The new data were recently presented at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego, CA. The study evaluated GlucoTrack’s accuracy in 172 adults with type 2 diabetes who were prescribed one or more medications for major medical conditions associated with diabetes. The experiment stratified participants into five medication groups, focusing on anti-cholesterolemia, anti-hypertension, anti-thrombotic, and anti-diabetic (prolonged duration and short and mixed duration) medications.
Based on over 7700 total measurements, GlucoTrack demonstrated comparable clinical and numerical accuracies among all participants, regardless of medication regime. Across medication groups, the clinical accuracy of GlucoTrack® ranged from 97.5% to 99.2% in the clinically acceptable A and B zones of the Consensus Error Grid, with all medication groups showing clinical accuracy above 72.5% in the A zone. Furthermore, no statistical difference was observed in mean and median absolute relative difference within each medication group (p>0.05).
Investigator comments
Amit Rozner, Senior Research Engineer at Integrity Applications and presenting author of the study, commented, “Adults with diabetes are significantly more likely to develop high blood pressure and high cholesterol, as well as have a higher risk for developing blood clots. The medications used to address these medical conditions, alongside with common diabetes medications, can have an impact on rapid glucose excursion and tissue hydration levels, which can lead to inaccuracies in both invasive and non-invasive glucose monitoring technologies. The results of this study gives us confidence that GlucoTrack provides accurate non-invasive glucose measurements independent of different medication regimes, making it an ideal tool for glucose monitoring in type 2 diabetes.”
Company comments
John Graham, CEO and Chairman of Integrity Applications, remarked, “Integrity Applications is committed to ensuring the development of an accurate and non-invasive glucose monitoring device suitable for people with type 2 diabetes, as well as those with prediabetes. A recent review of 27 approved meters demonstrated that more than 40% of them failed to meet the ISO 15197:2003 standards, in which they had received approval. These subpar performances might result from medications, test strips, sensors, and less than ideal measurement techniques. We are proud to have designed GlucoTrack to counteract these everyday challenges that can severely impact accuracy, while at the same time offer a revolutionary approach to diabetes management that goes beyond a better blood test.”
Source: PR Newswire
