The University of Virginia Leads Breakthrough Study on Artificial Pancreas Leading to FDA Approval

The University of Virginia Leads Breakthrough Study on Artificial Pancreas Leading to FDA Approval

The U.S. Food and Drug Administration (FDA) has approved an artificial pancreas system that is based on the technology from the University of Virginia Center for Diabetes Technology (UVA Center). The system automatically monitors and regulates blood glucose levels for Type 1 diabetes patients.

With a large-scale recent clinical trial backing the Virginia-based advancement, the results were published in the prestigious New England Journal of Medicine.

What is the system?

Called Control-IQ, this represents an advanced, next-generation automated glucose control system enabling “seamless integration of a continuous glucose sensor, insulin pump, and a smart control algorithm,” reported Boris Kovatchev, director of the UVA center. 

What is the benefit of the system?

Overall superior care management for Type 1 diabetes patients. The system frees up people form testing their blood sugar levels multiple times per day by a fingerstick and from delivery by multiple daily injections.

Who manufactured the system?

Tandem Diabetes Care

What is UVA’s contribution?

The pump in the system is programmed with an algorithm developed at UVA that uses glucose monitoring information to adjust the recipient’s insulin dose automatically. They also conducted the studies.

Why did the FDA approve the system?

They found that the multi-center clinical trial (again the results published in NEJM) found that the new pancreas system was more effective than existing treatments at controlling blood glucose levels in Type 1 diabetics. The study evidenced that the system improved blood glucose control throughout the day and overnight.

Study Summary

One hundred sixty-eight participants (14 and up) with Type 1 diabetes were randomly assigned to either the artificial pancreas system or sensor-augmented pump therapy with a continuous glucose monitor and insulin pump that did not automatically adjust insulin throughout the day. The investigators found that the users of the artificial pancreas system significantly increased the amount of time with blood glucose levels in the target range. In contrast, the time in range in the sensor-augmented pump group remained unchanged over six months.

The artificial pancreas patients experienced improvements across several diabetes control measures, including time with high and low blood glucose as compared with the sensor-augmented pump group.

The University of Virginia Health System News reports there were no hypoglycemia events in either group in the study. The study team found that in the group using the artificial pancreas, one patient developed diabetic ketoacidosis—where the blood becomes too acidic—which resulted from the equipment that delivers the insulin from the pump.

Who funded the overall research and development of the system?

· Paul and Diane Manning, Charlottesville, VA

· The Frederick Banting Foundation of Richmond

· JDRF’s Artificial Pancreas Project

· UVA Strategic Investment Fund No. 88


Lead Research/Investigator

Dr. Sue Brown