UVA-developed artificial pancreas approved by FDA
CHARLOTTESVILLE, Va. (CBS19 NEWS) -- The U.S. Food and Drug Administration (FDA) approved an artificial pancreas system from the University of Virginia Center for Diabetes Technology, according to a press release.
The device is called Control-IQ and it monitors and regulates blood glucose levels automatically for type 1 diabetes patients.
"We are excited that our decade-long research, which recently culminated in a large-scale clinical trial published in the New England Journal of Medicine, has been successfully translated to the clinical practice," said UVA Center for Diabetes Technology Director Boris Kovatchev, Ph.D. "This is a new-generation interoperable automated glucose control system, which allows seamless integration of a continuous glucose sensor, insulin pump, and a smart control algorithm."
The release stated Control-IQ tracks blood glucose levels with the continuous glucose monitor Dexcom G6 CGM and delivers hormone insulin automatically as needed.
That means people with diabetes can be freed from testing their blood sugar levels by a fingerstick multiple times a day as well as multiple daily injections of insulin.
The device is programmed with an algorithm to adjust the recipient's insulin dose by using glucose monitoring information.
Researchers found Control-IQ to be more effective in controlling blood glucose levels in type 1 diabetes patients than existing treatments, as the device improved blood glucose control throughout the day and overnight, according to the release.
There were 168 participants age 14 or older with type 1 diabetes who were randomly assigned to use the device or sensor-augmented pump (SAP) therapy with an insulin pump that did not adjust insulin automatically and a continuous glucose monitor.
The researchers found users of the device significantly increased the amount of time with their blood glucose levels in the target range and the SAP group remained unchanged over six months. Artificial pancreas users compared with the SAP group showed improvements in several diabetes control measures.
Severe hypoglycemia events did not occur in either group throughout the study. Diabetic ketoacidosis occurred in one participant using the artificial pancreas because of a problem with the equipment that delivers insulin from the pump, according to the release.
Kovatchev thanked everyone that supported the development of the artificial pancreas system. This included Paul and Diane Manning of Charlottesville, UVA Strategic Investment Fund Project No. 88, JDRF's Artificial Pancreas Project, Frederick Banting Foundation of Richmond, National Institute of Diabetes and Digestive and Kidney Diseases and National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases.
"We are thankful to everyone that supported the development of the artificial pancreas," said UVA endocrinologist Sue Brown, MD. "Artificial pancreas systems can help people with type 1 diabetes improve blood sugar control while also making it easier for them to manage their blood sugar levels."
Brown was the lead investigator of the clinical trial that tested Control-IQ according to the release.
Control-IQ was manufactured by Tandem Diabetes Care.