Scientists are getting closer to developing an artificial pancreas for patients with diabetes and a new computer-simulated system created by California researchers should bring the artificial pancreas even closer to the market.
The system, created by researchers at the University of California at Santa Barbara, Sansum Diabetes Research Institute (Santa Barbara) and Stanford Medical Center (Palo Alto), is designed to help scientists evaluate an investigational artificial pancreas comprised of an insulin pump and a continuous glucose monitor. Research about the system was published in this month's issue of Diabetes Technology & Therapeutics.
Specifically, the investigational artificial pancreas is comprised of the OmniPod Insulin Management System from Insulet (Bedford, Massachusetts) including the OmniPod insulin pump and Personal Diabetes Manager that controls it and a continuous glucose monitor, in this case either the FreeStyle Navigator from Abbott Diabetes Care (Alameda, California) or the DexCom STS7 from DexCom (San Diego). The new system includes an algorithm that automates the interaction between the pump and monitor, and facilitates the running of a variety of tests and challenges to the software and component devices. The UC Santa Barbara-developed software and algorithms are also being used with a number of other pumps and monitors in developing additional systems, according to the researchers.
Howard Zisser, MD, director of clinical research and diabetes technology at the Sansum Diabetes Research Institute, told Medical Device Daily that the new system provides a testing platform where researchers can test all of the components together, as opposed to testing each component individually. Hopefully, he said, that will help with the regulatory process of the artificial pancreas.
"I think it's nice for [FDA] to see everything operating as one ... it really helps to have everything in one system that we can test the whole system," Zisser said. "You don't want to have a system that the components work but when you plug them all together they don't work and that is one of the concerns of the FDA ... what happens when they start communicating together?"
The research is part of the artificial pancreas project, which is funded by the Juvenile Diabetes Research Foundation (New York) and is being conducted by an international group of diabetes research centers. The project's first goal is to integrate an insulin pump and continuous blood glucose monitor to closely replicate a healthy pancreas for patients with Type I diabetes patients whose pancreases no longer produce insulin, which is used by the body to control blood glucose levels. An artificial pancreas will allow for tighter and automated control of blood glucose levels, which would significantly help to avoid the long-term complications of the disease.
"While we still have a ways to go, this new system brings us much closer to making the artificial pancreas a reality for Type I diabetes patients," said lead author Eyal Dassau, PhD, diabetes team research manager at UC Santa Barbara. "This achievement is vital we now have a way, prior to patient trials, to fully verify and validate that an artificial pancreas can efficiently operate in the variety of conditions reflective of a large group of patients with this disease."
Zisser said the new system would help streamline the preclinical trials. "We plan to begin using it in the next several months," he added.
The other advantage of using the new system is that it is "plug and play," Zisser said. "We're going to be adding more pumps, more sensors, as they come on line."