Wednesday, March 23, 2011

Developing the Artificial Pancreas

A new strategic plan to guide diabetes-related research over the next decade was announced by NIH. The plan led by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), identifies research opportunities with the greatest potential to help millions living with or at risk for diabetes and its complications. Total costs of diabetes, including medical care disability and premature death reached an estimated $174 billion in 2007 in just the U.S.

The new strategic plan entitled “Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report” was developed by the Diabetes Mellitus Interagency Coordinating Committee” (DMICC). The Coordinating Committee facilitates communication and collaboration on diabetes research across the federal government by focusing on ten areas of diabetes research. Input for the strategic plan came from stakeholders both public and private, health advocacy groups, and external scientists who are leaders in the diabetes research field.

One research area is looking for bioengineering approaches to develop an artificial pancreas to improve management of diabetes. An artificial pancreas is a system that mimics as closely as possible the way a healthy pancreas detects changes in blood glucose levels and responds automatically to secrete the appropriate amounts of insulin. An artificial pancreas is based on mechanical devices that require at least three computers, a Continuous Glucose Monitoring (CGM) system, insulin delivery system, and a computer program that can adjust insulin delivery based on changes in glucose levels.

Scientists have taken the first steps to develop a mechanical artificial pancreas. Today, mechanical CGMs are now being used clinically so that diabetics can view real-time glucose levels, see fluctuations in levels, and be alerted when the levels become too high or too low.

These mechanical CGMs combine a continuous glucose sensor with a unit displaying glucose levels. The sensors are inserted under the skin for up to three to seven days and transmit readings of glucose levels in the tissue fluid every 1 to 5 minutes to a receiver carried by the individual.

Today, although current glucose sensors remain less accurate than traditional blood glucose meters, they offer people with diabetes an opportunity to spend more time in the close to normal glucose range without increasing the risk of brain injury from severe hypoglycemia.

The plan stresses the need to develop new sophisticated technological tools and instruments to treat diabetics and suggests looking for telemedicine technologies to find solutions. The thought is that software developers should work with investigators to develop algorithms to provide advice on diabetes management decisions, develop accelerometers to track physical activity to help make diabetes management decisions, and further develop sophisticated global positioning system technology to locate people if they need assistance.

To continue working towards developing and perfecting new monitoring devices that will work towards development of the artificial pancreas, NIH in February 2011 and last May issued Funding Opportunity Notices to do further research to develop the artificial pancreas.

In February 2011, RFA-DK-10-012 was issued by NIDDK to focus on major unanswered questions on Type 1 diabetes research that were mentioned in the NIDDK report “Autoimmunity, Imaging, and Biomarker Development, Diabetic Complications, and Engineering the Artificial Pancreas.” The FOA “Type 1 Diabetes Impact Award” is scheduled to be a $30 million five year program.

The FOA has a section on engineering the artificial pancreas and asks for researchers to develop a closed-loop artificial pancreas system which will combine the principles of engineering, nanotechnology, universal design, computer science, and informatics.

Last year, in May 2010, a FOA was also released by NIDDK and NICHD for a SBIR grant application. The FOA was entitled “SBIR to Develop New Therapeutics and Monitoring Technologies for Type 1 Diabetes Towards an Artificial Pancreas” (RFA-DK-10-008). The research supports innovative technologies to advance progress towards an integrated, long term automated glucose regulated insulin delivery system or artificial pancreas.

The strategic plan to guide diabetes-related research over the next decade is available for downloading at http://diabetesplan.niddk.nih.gov/. Printed copies will be available from the National Diabetes Information Clearinghouse beginning April 1, 2011 at 1-800-860-8747 or by email at ndic@info.niddk.nih.gov.