UVA’s Artificial Pancreas:FDA Approved – University of Virginia
Based on technology from the University of Virginia Center for Diabetes Technology, an artificial pancreas system was developed which can monitor and regulate blood glucose levels in Type 1 diabetes patients automatically. This technology is now approved by the U.S. Food and Drug Administration(FDA).
The director of the UVA center, Boris Kovatchev said “This was our decade-long research and we are excited that it has been successfully translated to the clinical practice after recently culminating in a large-scale clinical trial published in the New England Journal of Medicine. The technology is a new-generation interoperable automated glucose control system, that can allow seamless integration of a continuous insulin pump, glucose sensor, and a smart control algorithm.”
Tandem Diabetes Care manufactured the artificial pancreas system and this is called Control-IQ. This system uses a continuous glucose monitor to track blood glucose levels and delivers the hormone insulin as needed automatically. The delivery of insulin by multiple daily injections and testing blood sugar levels multiple times a day by fingerstick is no longer needed as this system frees people from painful treatment ways.
Better Managing Type 1 Diabetes
An algorithm developed at UVA is programmed
in the pump that can automatically adjust the recipient’s insulin does by using the glucose monitoring information.From a multicenter clinical trial published in the New England Journal of Medicine, FDA approval followed as it was seen that compared to the existing treatments available in controlling blood glucose levels in people with Type 1 diabetes, this new artificial pancreas system was more effective. Throughout the day and overnight, the system was seen to improve blood glucose control, in the study.
In the study, there were 168 participants with Type 1 diabetes, age 14 or older, assigned randomly to use either the sensor-augmented pump therapy with a continuous glucose monitor and insulin pump that did not automatically adjust insulin throughout the day or the artificial pancreas system.
Researchers found that in the sensor-augmented pump group, the amount of time with their blood glucose levels in the target range remained unchanged over six months while the artificial pancreas system users significantly increased the amount of time with their blood range. There were also improvements seen in the Artificial pancreas users in many diabetes control measures, including time with low and high blood glucose, compared with the group using the sensor-augmented pump. In either of the groups, no severe hypoglycemia events occurred during the study. Only one instance, due to a problem with equipment that delivers insulin from the pump, one participant in the artificial pancreas group had diabetic ketoacidosis, in which the blood becomes too acidic.
Development of the Artificial Pancreas
Dr. Sue Brown, UVA endocrinologist and the lead investigator of the clinical trial that tested Control-IQ said, ” To everyone who supported the development of the artificial pancreas, we are deeply thankful. With the artificial pancreas system, blood sugar control can be improved in people with Type 1 diabetes and also their blood sugar levels can be easily managed.”
Editor’s Note: UVA’s Artificial Pancreas:FDA Approved, UVA’s Artificial Pancreas:FDA Approved
