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114 New computer system to aid in artificial pancreas development By AMANDA PEDERSEN Medical Device Daily Staff Writer Scientists are getting closer to developing an artificial pancreas for patients with diabetes and a new computersimulated system created by California researchers should bring the artificial pancreas even closer to the market. The system, created by researchers at the University of California at Santa Barbara, Sansum Diabetes Research Institute (Santa Barbara) and Stanford Medical Center (Palo Alto), is designed to help scientists evaluate an investigational artificial pancreas comprised of an insulin pump and a continuous glucose monitor. Research about the system was published in this month’s issue of Diabetes Technology & Therapeutics. Specifically, the investigational artificial pancreas is comprised of the OmniPod Insulin Management System from Insulet (Bedford, Massachusetts) – including the OmniPod insulin pump and Personal Diabetes Manager that controls it –and a continuous glucose monitor, in this case either the FreeStyle Navigator from Abbott Diabetes Care (Alameda, California) or the DexCom STS7 from DexCom (San Diego). The new system includes an algorithm that automates the interaction between the pump and monitor, and facilitates the running of a variety of tests and challenges to the software and component devices. The UC Santa Barbara-developed software and algorithms are also being used with a number of other pumps and monitors in developing additional systems, according to the researchers. Howard Zisser, MD, director of clinical research and diabetes technology at the Sansum Diabetes Research Institute, told Medical Device Daily that the new system provides a testing platform where researchers can test all of the components together, as opposed to testing each component individually. Hopefully, he said, that will help with the regulatory process of the artificial pancreas. “I think it’s nice for [FDA] to see everything operating as one . . . it really helps to have everything in one system that we can test the whole system,” Zisser said. “You don’t want to have a system that the components work but when you plug them all together they don’t work and that is one of the concerns of the FDA . . . what happens when they start communicating together” The research is part of the artificial pancreas project, which is funded by the Juvenile Diabetes Research MEDICAL DEVICE INNOVATION 2010 Foundation (New York) and is being conducted by an international group of diabetes research centers. The project’s first goal is to integrate an insulin pump and continuous blood glucose monitor to closely replicate a healthy pancreas for patients with Type I diabetes – patients whose pancreases no longer produce insulin, which is used by the body to control blood glucose levels. An artificial pancreas will allow for tighter and automated control of blood glucose levels, which would significantly help to avoid the long-term complications of the disease. “While we still have a ways to go, this new system brings us much closer to making the artificial pancreas a reality for Type I diabetes patients,” said lead author Eyal Dassau, PhD, diabetes team research manager at UC Santa Barbara. “This achievement is vital – we now have a way, prior to patient trials, to fully verify and validate that an artificial pancreas can efficiently operate in the variety of conditions reflective of a large group of patients with this disease.” Zisser said the new system would help streamline the preclinical trials. “We plan to begin using it in the next several months,” he added. The other advantage of using the new system is that it is “plug and play,” Zisser said. “We’re going to be adding more pumps, more sensors, as they come on line.” (This story originally appeared in the April 2, 2009, edition of Medical Device Daily). To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 Sanuwave’s dermaPACE promotes internal healing in patients By OMAR FORD Medical Device Daily Staff Writer Usually wound therapies are treatments that include some sort of external component to help a patient heal. Sanuwave (Alpharetta, Georgia), a developer of noninvasive, biologic response activating devices in the regenerative medicine segment, is looking at going against conventional woundcare therapy logic and has developed an application that will stimulate the bodies own natural ability to heal. With dermaPACE, (Pulsed Acoustic Celluar Expression), the company is seeking to obtain an investigational device exemption from the FDA in looking at the safety and efficacy of the device in healing diabetic foot ulcers. The company reported adding its 22nd site to a clinical trial for dermaPACE last week. “Instead of trying to deal with healing externally, we’re actually trying to stimulate the body’s own healing ability,” Christopher Cashman, president/CEO Sanuwave, told Medical Device Daily. The device delivers pulsed acoustic energy waves to the affected area of the patient Cashman said, adding this energy is what stimulates the healing process. The enrollment for the dermaPACE trial for healing diabetic foot ulcers recently reached 75% completion. With 19 other trial sites in the U.S. and two international sites in the UK and Germany, the Southern Arizona VA site becomes the twenty-second site that is actively recruiting subjects for the dermaPACE trial. The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE device to sham application, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double blind, placebo control, parallel assignment study design. The company said that 200 patients would be involved in the clinical study. “So what would happen would be, a patient would come in, the physician would clean the affected site, apply gel and fire about five hundred pulses to the affected area,” he said. Patients in the active study arm receive four treatments over a two week period of pulsed acoustic energy waves to their wound. “Each patient is different but we believe the body will respond adequately after the four treatments,” Cashman said. The trial is set to end sometime next year, with the company hoping to launch the device in the U.S. in 2011. The device was already cleared in Europe. The company believes the device will have a tremendous impact in the diabetic illness market. According to 115 the American Diabetes Association (Alexandria, Virginia), 23.6 million people in the U.S. suffer from diabetes and another 57 million are pre-diabetic. The National Institutes of Health (NIH) reported that 15% of people with diabetes will acquire a non-healing ulcer in their lifetime, and chronic leg wounds (ulcers) are estimated to account for the loss of two million workdays a year at a cost of nearly $300 million in lost productivity. Diabetic foot ulcers are a recurrent condition and lead to more than 82,000 amputations annually. The Advanced Medical Technology Association (Washington) estimates it costs roughly $60,000 for a lower limb amputation that can result from a diabetic foot ulcer, representing an annual cost of $5 billion. Hospitalization costs alone for a patient with a diabetic foot ulcer can reach $16,000-$20,000 annually. “We are very encouraged by the support that the wound care medical community has shown our dermaPACE trial and their continued desire to join as the study nears its final enrollment stage,” Cashman said. As our clinical trial continues, we believe that we are getting closer to being able to offer the healthcare community and the patients who suffer from an estimated 1.5 million diabetic foot ulcers in the U.S. alone, a unique solution to a demanding medical problem at a reasonable cost.” Sanuwave was founded in 2005 and has a portfolio of products for the biologic signaling and angiogenic responses to restore the bodies natural healing process. The company already has a U.S. Class III PMA approval for its OssaTron device which stimulates healing in the foot and the elbow. (This story originally appeared in the Aug. 25, 2009 edition of Medical Device Daily.) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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