Tuesday, January 10, 2012

Artificial Pancreas Advancing

Advancing the development and use of an artificial pancreas, developing anti-obesity drugs, and exploring immune-based diabetes treatments will spearhead the Decade of Discovery’s research programs in coming months. Last year, the Minnesota Partnership for Biotechnology and Medical Genomics launched the “Decade of Discovery” to conquer diabetes.

The goal is to optimally treat and ultimately cure Type 1 and Type 2 diabetes through a multi-sector, coordinated initiative that will draw on Minnesota’s expertise in research, care delivery and public health. The Decade of Discovery along with leaders from the University of Minnesota and Mayo Clinic announced awards totaling $1.86 million in state funding for three projects under the auspices of the Minnesota Partnership.

Advancing the artificial pancreas is one of the research projects. The artificial pancreas works by combining a continuous glucose monitor and an insulin pump complete with sophisticated computer software to provide automatically the right amount of insulin at the right time.

Funding for $500,000 was awarded for a project called “The Chip” to explore and develop a specialized electronic chip that will improve glucose monitoring and provide a critical component to the artificial pancreas being developed by Mayo Clinic.

The chip will be a new type of sensor to transmit data wirelessly and be able to function in more locations in the body than current sensors. It may also last longer than current sensors and because it is made from grapheme may also be useful in detecting other diabetes factors such as lactate or ketone molecules. Based on a device concept invented at the University of Minnesota, the new sensor should be more reliable, stable, accurate, and make the artificial pancreas possible.

The other two research projects awarded will do research to develop an anti-obesity drug but this means that the researchers will need to discover new molecular targets for the drugs. The other research project will target insulin-specific T cells in an effective way to cure Type 1 diabetes in mice. In the coming year, the research team will test and validate mouse models containing human diabetes cells against various factors.

Another research project is ongoing with Boston University and Massachusetts General Hospital (MGH) to find the cure for Type 1 diabetes and make automated blood glucose control a reality. So far, engineers from Boston University have develop a closed-loop artificial pancreas blood glucose control system that uses frequent measurements of blood glucose concentration along with subcutaneous delivery of both rapid-acting insulin and glucagon as directed by a computer algorithm.

Previous artificial pancreas designs did not include the capability to administer glucagon. The artificial endocrine pancreas automatically makes a new decision about insulin and glucagon dosing every five minutes. The system is being tested in people with Type 1 diabetes at MGH with results recently published in “Science Translational Medicine”.

JDRF, researchers, clinicians, policymakers, and patients have called on the FDA to advance the development of an artificial pancreas. Also, over 100,000 people in the diabetes community signed JDRF’s petition which urged the FDA to adopt clear guidance. In addition, leading clinical organizations specializing in diabetes care are urging FDA to ensure that the development of an artificial pancreas is not delayed by unnecessary regulatory roadblocks.

On the regulatory front, on December 1, 2011, FDA issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat Type 1 diabetes. To facilitate development of the device, the draft guidance provides flexible recommendations for design and testing that meets statutory requirements for safety and effectiveness. When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.