A critical step for the future development of an artificial pancreas for diabetics and hypogycemics has been launched by Medtronic, Inc. (NYSE:MDT). Medtronic, located in Minneapolis, just finished the first enrollment of patients for an experimental device exemption (IDE) clinical trial of its innovation Predictive Low Glucose Management (PLGM) technology.
Medtronic, a global leader in medical technology, will perform a clinical trial to evaluate the safety of its next-generation integrated insulin pump and continuous glucose monitoring (CGM) system, the only technology available in the U.S, which works by sensing the glucose levels and starting insulin delivery when an acceptable minimum value is reached. Moreover, when the patient does not react to the Threshold Suspend alarm on the device, the PLGM technology enables the insulin pump to automatically stop the administration of insulin when glucose levels are restored. This technology is designed to better manage the challenges of hypoglycemia (low blood sugar), which can lead to a state of confusion, unresponsiveness and, in severe cases, to death, and rebound hyperglycemia (high blood sugar) that are associated to external insulin therapy in patients with diabetes. During this trial there will be the enrollment of 84 subjects in eight investigational centers in United States.
“Safely managing hypoglycemia without causing a rebound hyperglycemic episode is a key challenge in managing diabetes,” said Ronald Brazg, M.D., FACE clinical assistant professor of medicine, Division of Metabolism and Endocrinology at the University of Washington, and director of Rainier Clinical Research Center, which is one of the participating centers in this trial, in Medtronic press release. “This important study leads the industry-wide effort to close the diabetes treatment loop with tools that help achieve better glycemic control.” added Dr. Ronald Brazg.
“This study marks yet another important milestone toward the goal of an artificial pancreas. As we continue to lead the world with advances in insulin delivery, sensor technology and algorithms, we will be more able to help people with diabetes enjoy greater freedom and experience better health,” said Alejandro Galindo, vice president and general manager of the Intensive Insulin Management business at Medtronic.