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 The JDRF Artificial Pancreas Project > Research Meetings Delivering the keynote address at the Diabetes Technology Society annual meeting in Bethesda, Maryland, Dr. Kowalski, who manages Metabolic Control programs for JDRF, noted that diabetes monitoring and control technologies were virtually non-existent from the development of insulin the 1920s until the 1990s. But since the introduction of CGM devices in the late 90s, the field has moved quickly to provide people with type 1 diabetes with more accurate and more sophisticated devices to help them manage their diabetes. And that pace should continue to accelerate, as results from the JDRF trials on CGM are analyzed and reported on, and pave the way not just for increased usage of monitors, but the development of a closed-loop artificial pancreas. "What the trials are showing is that, in general, people who use CGM devices regularly can drive down their hemoglobin A1c levels, and they can do so without an increase in severe low blood sugar episodes. That's incredible news from a patient standpoint, as this is really the first time we've seen a diabetes technology or diabetes treatment protocol create tighter control without increasing the risk of hypoglycemic episodes," Dr. Kowalski said. "But the sad fact is that our trials show that there remain sizable obstacles for all people with diabetes, particularly teenagers and younger children, to use CGM devices regularly. What that says to me is that the need for a closed loop system -- a fully automated monitor and pump technology - has never been greater. But it's also never been more technically feasible." He noted that the aim of the JDRF's Artificial Pancreas Project is to do just that: to accelerate the availability of a first generation artificial pancreas, to ensure that such a device and its components are widely available, to make certain devices from multiple companies are approved and reimbursed by insurance carriers, and to create a robust and thriving market that stimulates ongoing industry investment in next generation technologies. That project has been proceeding on three tracks. The first is the extensive JDRF Continuous Glucose Monitoring clinical trials, multi-site human clinical studies around the U.S. that are looking at quantifying the impact of CGM devices on people with type 1 diabetes. Preliminary results from those trials, which are still ongoing, were published in the prestigious New England Journal of Medicine and presented at the annual meeting of the European Association for the Study of Diabetes, and showed that CGM did in fact significantly improve diabetes control; trial participants who used the devices regularly -- six days per week or more -- saw a reduction in A1c levels, without an increase in hypoglycemia. The second track is JDRF's Artificial Pancreas Consortium, which is simultaneously working to bring together scientists from multiple disciplines to safely and effectively link blood sugar sensors with insulin delivery systems, using a sophisticated algorithm to ensure the device accurately mimics how a human pancreas does - sensing glucose and delivering just the right amount of insulin, taking into account a wide range of variables such as insulin sensitivity, exercise, stress levels, meal types and others. The third part of the project involves JDRF creating partnership with industry participants to build artificial pancreas technologies and create a robust, competitive marketplace for them. Dr. Kowalski noted that the path forward will most likely include a series of developments that build on each other - perhaps starting with an overnight closed loop system that regulates blood sugar while a child or adult is asleep, rather than throughout the day when they are active and additional variables are involved. "We're now quickly moving ahead from experimental closed loop systems in a hospital setting towards feasibility studies in an outpatient setting, and then pivotal trials leading to an FDA submission," he noted. "But those next steps will require the development of a novel mobile system that incorporates a glucose sensor, an algorithm, and an insulin delivery mechanism. And that can only be done by partnering with industry." He noted that issues such as predictive alarms, insulin shut-off, minimizing hypoglycaemia and hyperglycemia (dangerously high levels of blood sugar), and the addition of other pancreatic hormones all need to be addressed either sequentially or in combination as these devices are developed. And perhaps most important are ergonomic considerations - developing a device so small, simple, and easy-to-use that it will be used regularly. Dr. Kowalski noted that despite the significant next steps that need to be taken towards the development of an artificial pancreas, he continues to be amazed at the terrific progress that has been made to date, particularly in the recent past, and expressed his gratitude - as a person with type 1 diabetes - to the researchers, clinicians, and technologists who are working with JDRF to make the artificial pancreas a reality. JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type 1 research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children and adults suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation. Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.3 billion to diabetes research, including more than $156 million in FY2008. In FY2008 the Foundation funded more than 1,000 centers, grants and fellowships in 22 countries. |
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