We are in the midst of a groundbreaking 45-hour medical research study on the artificial pancreas (AP.) The clinical trial began Monday, June 25th and ends today on June 27th. This significant milestone study is 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, are 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 are able to move about freely outside the confines of the research setting for short periods of time. This research is part of a major collaborative effort funded by the Juvenile Diabetes Research Foundation focused on developing the artificial pancreas. Our research partners for this study are the University of California, 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 Sansum Diabetes states that “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.”
Dr. Zisser went on to say that “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.”