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Panel Concludes Artificial Pancreas for Type 1 Diabetes Safe for Outpatient Testing

Kathleen Blanchard's picture

Diabetes experts have convened to present recommendations for oupatient testing of the artificial pancreas technology system for treatment of type 1 or juvenile diabetes that would eliminate the need for frequent insulin injections and blood testing. A panel of experts from the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH), leading clinicians and industry experts outlined a plan for testing the system outside of hospital and controlled settings that they concluded should move forward.

Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies from the Juvenile Diabetes Research Foundation International (JDRF) says,

"An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease. In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from type 1 diabetes."

Artificial Pancreas Safely Tested in Controlled Settings

Artificial pancreas technology has been safely tested in hospital and controlled settings and the scientists say it's time to move testing to the "real world". Jeffrey Brewer, President and CEO of JDRF said, "We believe a safe and effective first generation artificial pancreas system is possible with today's technology, even as we continue to encourage development of improved devices. Experts at today's FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients,"

The conclusion of the panel was that the artificial pancreas technology is ready for testing outside of controlled settings. Included in the presentation was an outline of which subset of patients should be included, how to safely move studies from inpatient to testing in the "real world", and recommendations for ensuring safety of the patients entered in studies.

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Robert Sherwin, M.D., Yale University, who chaired the panel, says he "believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings."

Other experts speaking at the workshop included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.

"The incidence of type 1 diabetes is on the rise. Today's tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it's time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease," added Mr. Brewer.

Development of the artificial pancreas device began in 2005 to help individuals living with type 1 diabetes manage the disease. The device automatically detects blood sugar levels to deliver needed therapy, potentially eliminating the need for frequent blood glucose testing and insulin injections; improving quality of life.

There is no cure for type 1 diabetes that is thought to be an autoimmune disorder. The JDRF has worked with university-based mathematicians, engineers, and diabetes experts to develop the artificial pancreas system that uses computer algorithms to help patients living with type 1 diabetes maintain tight blood sugar control that can prevent long term complications of the disease.


Artificial Pancreas Project