Every once in a while it’s a good thing to stand back, take a look at where you have been and gather your strength to go forward. So today we are going to review what is happening with the Juvenile Diabetes Foundations Artificial Pancreas Project.
Started in 2005 as a research project, it has become a high stakes partnership between industry and science to develop a runner-up to a cure. The Artificial Pancreas Project aims to develop a machine that combines the insulin delivery accuracy of an insulin pump with the blood glucose detection capabilities of a continuous monitoring device in a closed loop system that has a rudimentary brain.
In this type of setup the two devices talk to each other and, using mathematical algorithms, determine how much insulin to automatically deliver into your system.
Presto! You, the middle man, are taken out of the equation (which is the way most of us would like it). After all, in people without diabetes all of those minute calculations take place behind the scenes and happen quite well without mindful input. Having a closed loop system would help those with type 1 (or type 2 patients with end stage beta cell destruction) lower the ever-present, everyday diabetes stress.
Hospital-based trials using these devices have shown them to be effective in controlling blood glucose levels and reducing overnight hypoglycemia in people with type 1.
In June of 2011, the ties that bind efficacy and efficiency came together in a study that showed that Medicare would actually save over 1.9 billion over 25 years as a result of the reductions in diabetes complications stemming from the device’s projected ability to improve glucose control.
Next, the Project participants need to figure out how well the device works in out-patient and real-use situations. The Food and Drug Administration (FDA) gave the project a shot in the arm with its December 2011 guidance paper on accelerating the development and availability of artificial pancreas technology.
The paper is a first step in clearing the way for fast track development. And just this March, JDRF has responded to the FDA document with suggestions of its own—they want the FDA to take a broader view in its definition of allowable clinical trials and to formally recognize “Time in Range” (for blood glucose) as a primary study endpoint.
The FDA’s positive response to the technology has spurred expansion in the medical device market. Companies such as Abbott, Medtronic, Dexcom and Roche are competing to bring higher end sensors and delivery devices to market.
And Joslin has already started to make use of this technology in research on insulin dosing—a team headed by Howard Wolpert, M.D., studied the amount of insulin needed to cover meals high in fat versus low in fat, with the closed loop as the system to maintain glucose control.
The next two years should be exciting as more refined sensor technology becomes available for everyday use—bringing us a step closer to a life altering technologies
Further information on the artificial pancreas project can be found at www.jdrf.org.