Feb. 11, 2010 – At the 3rd International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Basel, Switzerland, Roche Diabetes Care, the University of California Santa Barbara (UCSB), and Sansum Diabetes Research Institute announced their expanded collaboration in the Artificial Pancreas Project sponsored by the Juvenile Diabetes Research Foundation (JDRF).
Roche Diabetes Care is supplying Accu-Chek® Spirit Combo insulin pumps to UCSB/Sansum and will be supplying them to other members of the Artificial Pancreas consortium, which comprises those teams participating in JDRF’s Artificial Pancreas Project. The Artificial Pancreas System (APS) platform was developed by the UCSB in collaboration with the Sansum Institute in Santa Barbara, and is used by researchers around the world. Roche Diabetes Care’s Accu-Chek Spirit Combo insulin pump integrates plug-and-play with UCSB/Sansum’s APS, with no physical modification. With its Bluetooth® enabled communication, the Accu-Chek Spirit Combo insulin pump extends the communication range of the APS. As the Accu-Chek Spirit Combo is not cleared for use in the US, all research using the pump will be conducted in Europe.
“Roche Diabetes Care has been instrumental in supporting the addition of their pump to our Artificial Pancreas platform,” commented Dr. Howard Zisser, director of clinical research at Sansum. “This milestone should improve the communication performance of the system while also expanding the number of possible research centers that can use it to help close the loop for automated insulin delivery for patients with type 1 diabetes. The extended communications range will also allow research subjects greater freedom during clinical trials.”
JDRF began the Artificial Pancreas Project in 2006, and has multiple teams in multiple countries working to develop automatic systems that can replicate the glucose-regulating functionality of a normal pancreas and its insulin-producing (beta) cells. The US FDA has designated development of an artificial pancreas as one of its critical path initiatives, applying FDA resources to accelerate and optimize research and development efforts.
An artificial pancreas system consists of a continuous glucose monitor and a continuous subcutaneous insulin infusion pump, both of which are available in the market today, and a controller linking the monitor and pump, running a highly sophisticated algorithm to determine the appropriate amount of insulin to deliver and the timing for that delivery, based on evaluation of real-time glucose readings. This constitutes a “closed-loop” system, taking the patient out of the glucose measurement and insulin dosing processes. Preliminary research has already shown that patients with type 1 diabetes using closed-loop insulin therapy experience less variability in their blood glucose levels. Reduced variability in blood glucose levels in turn reduces their risk of short and long-term diabetes complications, such as severe hypoglycemic events or cardiovascular diseases.
“The development of an artificial pancreas system is an essential step towards an ultimate cure for type 1 diabetes – a bridge to a cure,” said Aaron Kowalski, PhD, Assistant Vice President for Glucose Control at JDRF and Research Director of JDRF’s Artificial Pancreas Program. “This system will allow researchers around the world to accelerate the development of control algorithms and their testing, taking another step towards the day when people with diabetes can realize the tremendous promise of this exciting research.”
“This collaboration demonstrates our commitment to the JDRF Artificial Pancreas Program, and leverages our expertise in insulin delivery and blood glucose monitoring. We are pleased to have the opportunity to support this important JDRF initiative, and to help the Artificial Pancreas become reality,” states Rem Laan, Head of Marketing Insulin Delivery Systems, Roche Diabetes Care.
About the Artificial Pancreas System
The first step toward an artificial pancreas is reliable communication between insulin pumps, continuous glucose sensors and control algorithm. The APS modular architecture supports multiple pumps, sensors and any control algorithm. “This system facilitates researchers from around the world to focus on developing the core algorithms for the artificial pancreas without the burden that is associated with the integration of hardware, software and a human machine interface,” commented Eyal Dassau, lead scientist for UCSB’s Artificial Pancreas System. “The APS is the only system that allows fully automated closed-loop clinical trials and its design allow it to be expanded as new devices are available.
JDRF is a global leader in research leading to better treatments and cures for type 1 diabetes. It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide. JDRF was founded in 1970 by parents of children with type 1 diabetes, and now has more than 100 locations worldwide. Last year, it funded more than $100 million in diabetes research, in more than 20 countries.
About UC Santa Barbara
UC Santa Barbara is a world-renowned research institution. The two groups at UCSB involved in Type 1 diabetes research are the Department of Chemical Engineering, in 2007 ranked ninth in the United States and second in the University of California system by U.S. News and World Report, and the Biomolecular Science and Engineering Program, which offers a unique interdisciplinary approach to graduate training and research spanning Biochemistry, Molecular Biology, Bioengineering and Biomolecular Materials.
About Sansum Diabetes Research Institute
Sansum Diabetes Research Institute is a non-profit research center devoted to the prevention, treatment, and cure of diabetes through research and education. It is best known for its work on methods to detect and chart the progress of diabetes and its expertise in new diabetes technology.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
About Roche Diabetes Care
Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 35 years, the Accu-Chek brand has been dedicated to enable people with diabetes to live life as normal and active as possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way. Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management. It encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – leading to an improved medical outcome.
About Accu-Chek® Combo
Accu-Chek Combo is a new interactive diabetes management system consisting of an insulin pump and an intelligent blood glucose monitoring device that combines blood glucose monitoring, a smart bolus advisor, an integrated pump remote control function, extensive data management and graphing capabilities. With all of this intelligence and Bluetooth® enabled wireless remote pump operation, the Accu-Chek Combo system is the easy, quick and discreet insulin pump system that puts effective diabetes management into the palm of the hand.
The Accu-Chek Combo insulin pump system is not cleared for use in the US, and all research using the Accu-Chek Spirit Combo will be conducted in Europe.
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Roche Diabetes Care (http://www.accu-chek.com)
JDRF Artificial Pancreas Project (http://www.artificialpancreasproject.com/)
Sansum Diabetes Research Foundation (http://www.sansum.org/)
Doyle Research Group at UCSB (http://thedoylegroup.org/)
US FDA’s Role in the Development of an Artificial Pancreas
Source: press release