JDRF Partners with Animas to Develop Automated System to Better Control Diabetes Representing First Step to Artificial Pancreas
JDRF announced today an innovative partnership with Animas Corporation to develop an automated system to help people with type 1 diabetes better control their disease – if successful, this would be the first step towards developing a fully automated artificial pancreas, which would be among the most significant advances in the treatment of type 1 diabetes: the development of an artificial pancreas, a fully automated system to dispense insulin to a person living with type 1 diabetes based on real-time changes in blood sugar levels.
Animas, a Johnson & Johnson company, is a leading manufacturer and distributor of insulin delivery and glucose management systems including the OneTouch® Ping™. Objectives of the partnership are to develop an automated system to manage diabetes, conduct extensive clinical trials for safety and efficacy, and submit the product to the U.S. Food and Drug Administration for approval.
The first generation system developed through this partnership will not be fully automated. Rather, in this first step towards an artificial pancreas system, the computer software will guide insulin delivery, automatically taking action when blood sugar is getting too high or too low. For example, the system would automatically discontinue insulin delivery to help prevent hypoglycemia, and then automatically resume insulin delivery based on a specific time interval (i.e., 2 hours) and/or glucose concentration. It will also automatically increase insulin delivery to reduce the amount of time spent in the high range and return to a pre-set basal rate once glucose concentrations have returned to acceptable levels. The user still needs to make decisions about insulin dosage, particularly around meals.
Even this first step will significantly reduce the number of highs and lows, and lower long-term blood sugar levels. The computer software that will run this system is still being developed, which makes it difficult to predict what the outcomes of using this system will be, but this first-generation system will help many more people with diabetes achieve target A1c’s of 7% or lower currently do so today. Most important, JDRF believes it will do that with far fewer low blood sugar problems.
“Although this partnership is focused on a first-generation system, not a fully automated artificial pancreas, such a system could provide better clinical outcomes for those with type 1 diabetes – reducing if not eliminating the high or low blood sugar problems that send people with diabetes to the hospital, cause accidents or injuries, and make living with diabetes so difficult,” explained Aaron Kowalski, Ph.D., Assistant Vice President of for Glucose Control at JDRF and Research Director of the JDRF Artificial Pancreas Project. “And better control would significantly lower the key risk for developing the devastating long-term complications of the disease, including eye disease, kidney disease, nerve disease or cardiovascular disease.”
The ultimate goal – a completely automated system – will take longer. Such a system will likely require next generation continuous glucose monitors, pumps that can deliver more than just insulin, and faster-acting insulin. The JDRF Artificial Pancreas aims to accelerate the delivery of multiple artificial pancreas systems.
“If successful, the development of this first-generation system would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, PhD, President and Chief Executive Officer of JDRF. “Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugars within a target range. But even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating and treating themselves throughout the day.”
The JDRF-Animas partnership will build upon the progress made since 2006 in the JDRF-funded Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts that has developed the computer programs needed for an artificial pancreas, and established their scientific feasibility. The goal of an artificial pancreas has also been embraced by the U.S. Food and Drug Administration, which along with JDRF and National Institutes of Health, brought together scientists, regulators, industry, and patients for scientific workshops on the subject in 2005 and 2008; the FDA has designated an artificial pancreas as one of its “critical path” initiatives. The development of an artificial pancreas system is an essential step towards an ultimate cure for type 1 diabetes – a “bridge to a cure.”
JDRF’s goal is to have multiple versions of an artificial pancreas available for people with diabetes; the organization will continue to explore partnerships with other industry leaders.
JDRF is the catalyst that is bringing together the disparate disciplines of CGM developers, insulin pump manufacturers, diabetes clinicians, and scientists and mathematicians that will be needed to develop an artificial pancreas. It is the organization that provided definitive research about CGM devices to show that they help improve clinical outcomes of people with diabetes. JDRF has been the driving force behind using research to convince insurers to cover CGM devices, clinicians to prescribe them, and people with diabetes to use them. Eventually, JDRF will use research findings to convince insurers that these new systems’ benefits justify coverage. And it is taking the first steps towards an artificial pancreas with this partnership and the development of first generation semi-automated systems to man age diabetes.
DexCom, Inc., a leading manufacturer of CGM devices, will supply the CGM technology for the system to be developed by JDRF and Animas.
More information about the JDRF-Animas partnership and the development of a first generation automated system to manage diabetes is available at www.jdrf.org/artificialpancreasproject. The site also includes information for people with type 1 diabetes about research leading to the development of an artificial pancreas, as well as interactive tools, chats with researchers, and access to information about clinical trials.
The eventual aim of JDRF, a fully automated artificial pancreas, will help people live better, healthier, easier lives, until research gets to a biological cure. Today JDRF is historically poised to translate research into the first steps toward real treatment options, by partnering with Animas, a Johnson & Johnson company that manufactures insulin delivery and glucose management systems, to develop a first-generation artificial pancreas.
