The Sansum Diabetes Research Institute is pleased to announce that a historical event for the treatment and cure of diabetes occurred this week at its research center in Santa Barbara, with a groundbreaking, 45-hour medical research study on the artificial pancreas.
The clinical trial began Monday and ended Wednesday. This significant milestone study was the largest in the United States, featuring five diabetes mellitus patients (deemed the “Fantastic Five” for their willingness to participate) who are supported by the AP in a semi-outpatient environment.
For the first time, the patients, not the researchers, were in control of this medical device, which runs automatically, reacting and delivering precise amounts of insulin when the body needs it, exactly like a normal human pancreas. Clinical trial participants were able to move about freely outside the confines of the research setting for short periods of time.
This research was part of a major collaborative effort funded by the Juvenile Diabetes Research Foundation focused on developing the artificial pancreas. Research partners for this study were UC Santa Barbara’s Chemical Engineering Department/Center for BioEngineering and the University of Virginia Center for Diabetes Technology.
In observing the trial patients, Dr. Lois Jovanovič, chief scientific officer at the Sansum Diabetes Research Institute, said, “It’s stunning to see the changes, the transformations these patients experience, while using the AP. They are no longer tethered to uncomfortable instrumentation, such as IV poles and medical devices, and are no longer confined to our inpatient setting. The AP components are held inside a small fanny pack that goes around the subjects’ waists. The ‘Fantastic Five’ are at liberty to attend to activities associated with daily living. You can plainly see they are more comfortable and confident about managing their diabetes; their blood sugar control and insulin levels are automatically ‘managed by machine.’ This trial is significant because it means we have turned the corner on diabetes mellitus treatment by making strides to restore people with diabetes to a normal, active lifestyle with improved management of their condition.”
According to Dr. Howard Zisser, director of clinical research and technology at Sansum Diabetes, “The device automates insulin delivery for people with Type 1 diabetes. It consists of a continuous glucose sensor, an insulin pump and a controller that decides in real-time how much insulin to deliver. Our trial is exceeding our expectations. It’s exciting to see patients operating the systems themselves as we monitor them remotely from the lab. They are not confined to the test laboratory; they have the liberty to move around our three-story facility and even take a walk outside.”
He added: “Another milestone will hopefully be the approval of a low glucose suspend system that will automatically stop insulin for short periods if someone’s glucose is low and they don’t respond to alarms. This system is widely available outside the United States.”
— Sarah Ettman-Sterner is the director of communications for the Sansum Diabetes Research Institute.