WILMINGTON, Del. and ASHDOD, Israel, June 12, 2017 /PRNewswire/ -- Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a non-invasive device for measuring glucose levels in people with type 2 diabetes and prediabetes, announced new data demonstrating the clinical performance of GlucoTrack, further supporting its suitability for people with type 2 diabetes across various medication regimes. The 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.
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."
Following the collection of 7,700 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).
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."
GlucoTrack® is a truly non-invasive monitoring device that 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 measured signals are analyzed using a proprietary algorithm and then a calculated glucose level is displayed on a small handheld device the size of a small mobile phone. The glucose results are stored in the device and used for an estimated HbA1c level using a proprietary algorithm. The device can also display glucose values graphically, enabling the user to monitor glucose levels over a period of time.
GlucoTrack® has received CE Mark and KFDA approvals for type 2 diabetes and prediabetics, and is currently in the early stages of commercialization in Europe, South Korea and other geographies.
GlucoTrack® is expected to begin clinical trials for United States FDA approval in late 2017. The product is currently experimental in the United States and is limited to investigational use only.
About Integrity Applications, Inc.
Integrity Applications was founded in 2001 and is focused on the design, development and commercialization of non-invasive glucose monitoring technologies for people with type 2 diabetes and prediabetes. The company has developed GlucoTrack®, a proprietary non-invasive glucose monitoring device designed to obtain glucose level measurements in about a minute without the pain, incremental cost, difficulty or discomfort of conventional invasive finger stick devices. Integrity Applications Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Ashdod, Israel. For more information, please visit www.integrity-app.com and www.glucotrack.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "expect", "plan" and "will" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect Integrity Applications' actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Integrity Applications' results include, but are not limited to, the ability of Integrity Applications to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Integrity Applications' filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the SEC on March 30, 2017.
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SOURCE Integrity Applications, Inc.