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New chairman was the lead investigator for the first randomized controlled multicenter trial of an outpatient artificial pancreas product.
June 17, 2021
By: Michael Barbella
Managing Editor
Integrity Applications Inc., innovator of GlucoTrack, a non-invasive device for measuring glucose levels in people with Type 2 diabetes and prediabetes, has appointed David C. Klonoff, M.D., as chairman of the company’s Scientific Advisory Board. Klonoff is a world-renowned endocrinologist specializing in diabetes technology. He is currently the medical director of the Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Medical Center in San Mateo, Calif., and a clinical professor of Medicine at UCSF. Klonoff has been a principal investigator on more than 120 clinical trials of diabetes drugs and devices. He was the lead investigator for the first randomized controlled multicenter trial of an outpatient artificial pancreas product, whose results were published in the New England Journal of Medicine. He chaired the scientific advisory board for the first U.S. Food and Drug Administration (FDA)-cleared insulin patch pump and participated in developing the first FDA-cleared dedicated diabetes telemedicine system. Klonoff has chaired or served on 56 grant review panels including for NIH, CDC, NASA, NSF, U.S. Army, NOAA, ADA, and JDRF. Klonoff has received numerous awards for his work in the field of diabetes including an FDA Director’s Special Citation Award in 2010, and most recently the American Diabetes Association’s 2019 Outstanding Physician Clinician Award. “Dr. Klonoff is a recognized global leader in diabetes technology, and we are excited that he is joining the company,” commented Erez Ben-Zvi, Integrity’s general manager and vice president of Product. “As we move towards the next generation GlucoTrack and forge ahead with our plans for FDA clinical trials and U.S. go-to-market strategy, his guidance and leadership will be invaluable to us.” In chairing of the company’s Scientific Advisory Board, Klonoff will utilize his vast scientific and product expertise in the field of diabetes to advise on critical clinical and regulatory strategies, assist with clinical research, design of clinical trials, and in an FDA submission. “I am impressed by the company’s new management team, their vision for the next generation GlucoTrack and focus of the U.S. markets,” said Dr. Klonoff. “I look forward to working closely with the company on progressing GlucoTrack’s product development and it’s clinical and regulatory programs.” GlucoTrack is a 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 an ear clip with sensors that clips to the earlobe and measures the user’s glucose level using 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 approvals for CE Mark in Europe and from the Ministry of Food and Drug Safety in South Korea for type 2 diabetes and prediabetes and is currently available in selected markets in Europe and Asia.
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