WILMINGTON, Del. and ASHDOD, Israel, Sept. 7, 2017 /PRNewswire/ -- Integrity Applications, Inc. (OTCQB: IGAP), innovator of GlucoTrack®, a non-invasive device for measuring glucose levels in people with type 2 diabetes, presents Data Demonstrating that the performance of GlucoTrack is comparable among patients with prediabetes, newly diagnosed type 2 diabetes and long duration of type 2 diabetes, at the 53rd EASD Annual Meeting in Lisbon, Portugal.
The study evaluated the performance of GlucoTrack, a non-invasive glucose monitoring device, in all diabetes populations: patients with prediabetes (N=7), newly diagnosed patients with type 2 diabetes (diabetes duration ≤ 5 years; N=9) and individuals with a long-duration of type 2 diabetes (diabetes duration >5 years; N=16). All participants underwent a calibration day and a trial day that included a pre-prandial measurement and a standardized breakfast followed by six additional measurements over 30-minute intervals. In all groups, 100% of the measurements were in the clinically acceptable A and B zones of the Consensus error grid, with more than 92.5% in the clinically accurate zone A. Mean and median absolute relative difference (ARD) values ranged from 15.6% to 18.3% and from 12.7% to 13.9%, respectively.
"The finding of comparable clinical and numerical accuracies across all groups indicates that the device is suitable for people with long and short durations of type 2 diabetes as well as for people with prediabetes, signifying that many patients worldwide may benefit from GlucoTrack," says Dr. Tamar Lin, Lead Research Scientist at Integrity Applications. Non-invasive glucose monitoring devices for home use aim to overcome the barriers of current invasive glucose monitoring methods by offering a simple, painless and convenient means to measure glucose levels. "GlucoTrack holds the potential to promote frequent glucose self-monitoring and thus improve glycemic control. This may in turn reduce diabetes-related complications and in certain cases even prevent the development of diabetes in individuals with prediabetes," said Eugene Naidis, VP R&D at Integrity Applications.
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 technologies. 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 to estimate HbA1c level using a proprietary algorithm. The device can also display glucose values graphically, enabling the user to monitor glucose levels over time.
GlucoTrack® has received CE Mark and KFDA approvals for type 2 diabetes and pre-diabetics, 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. The product is currently experimental in the United States and is limited to investigational use only.
About Integrity Applications, Inc.
Integrity Applications, Inc. (OTCQB: IGAP) 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.
Sami Sassoun, CFO Integrity Applications
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SOURCE Integrity Applications, Inc.