The Juvenile Diabetes Research Foundation has announced a partnership with Animas Corp. and DexCom Inc. to develop a first-generation automated system for managing type 1 diabetes, as well as a collaboration with Becton, Dickinson and Co. to develop novel products that would work with insulin pumps to enhance insulin delivery.
The JDRF will provide $8 million over the next 3 years to Animas, a Johnson & Johnson company that manufactures insulin pumps. DexCom, a manufacturer of continuous glucose monitoring (CGM) devices, will supply that part of the technology for the system. The money will fund clinical trials of efficacy and safety, with the first-generation system expected to be ready for regulatory review within 4 years, Alan Lewis, Ph.D., JDRF president and CEO, said in a telephone briefing.
While the ultimate goal is to develop a fully automated “closed-loop” system to regulate blood glucose levels, the initial version of the system would still require some input from the user and therefore would only be partially “closed.” It would consist of the insulin pump and the CGM—which are currently available but operate separately—with a computer program that would wirelessly link the two components, enabling the device to automatically increase insulin delivery upon detection of hyperglycemia and shut off delivery when hypoglycemia occurs, subsequently resuming delivery when glucose levels return to normal.
Although the patient would still need to manually instruct the pump to deliver insulin at certain times—particularly at meals—the system would improve overall control by minimizing the amount of time a patient spends out of target glucose range, which is typically more than 70% even among the most sophisticated patients with type 1 diabetes, said Aaron Kowalski, Ph.D., the JDRF's assistant vice president and director of glucose control research.
In a follow-up interview, Dr. Kowalski said that this development partnership is in addition to JDRF's ongoing annual $4-$5 million funding of academic research in closed-loop insulin delivery systems involving devices made by all of the leading pump and CGM manufacturers.
The JDRF also announced that it will provide $4.3 million over the next several years for the nonexclusive collaboration with Becton Dickinson.
Becton Dickinson will use the foundation's funds for research and development of new products aimed at delivering insulin from pumps via either infusion sets or patch-pump configurations, with the goal of minimizing pain, kinking, occlusions, and site infections. The program will also aim to speed insulin action, a JDRF statement said.
One facet will utilize Becton Dickinson microneedles, which speed subcutaneous insulin uptake at the delivery site. Microdelivery technology development will initially focus on improved glucose control. Ultimately it targets the technology of a closed-loop artificial pancreas system utilizing insulin pumps and continuous glucose sensors, with communication between the two devices.
More information about all of JDRF's initiatives is available at www.artificialpancreasproject.com
A first-generation automated insulin delivery system would consist of an insulin pump and a continuous glucose monitor that are linked wirelessly with a computer program.
Source Courtesy JDRF (Juvenile Diabetes Research Foundation)