Devices & Diagnostics

Medtronic reports positive results for insulin pump trial

Medtronic Inc. (NYSE: MDT) reported that a clinical trial showed its insulin pump system with a sensor helped patients with type 1 diabetes control their glucose levels better than multiple daily injections. Adult and pediatric patients in the study achieved better glucose control without an increase in hypoglycemia, which occurs when a patient’s blood sugar […]

Medtronic Inc. (NYSE: MDT) reported that a clinical trial showed its insulin pump system with a sensor helped patients with type 1 diabetes control their glucose levels better than multiple daily injections.

Adult and pediatric patients in the study achieved better glucose control without an increase in hypoglycemia, which occurs when a patient’s blood sugar is too low. Patients using the pump also showed a reduction in glycated hemoglobin (A1c), or blood sugar levels, according to a statement.

The company calls its sensor-augmented insulin pump therapy the MiniMed Paradigm Real-Time Revel System. Medtronic’s Revel technology received sales and marketing clearance from the Food and Drug Administration in March. The company says Revel is the first system to integrate sensors with an insulin pump by alerting patients when their glucose levels fall out of a desired range.

The results of the study were published online in The New England Journal of Medicine.

“This study clinically validates our sensor-augmented pump system, the foundation upon which we are building a closed-loop system or artificial pancreas,” said Dr. Francine Kaufman, a vice president with Medtronic’s diabetes business.

The holy grail of medical device makers targeting the vast diabetes market is a fully automated “closed-loop” system in which sensors monitor glucose levels, advanced software crunches the data and feeds it to pumps that deliver the right dose of insulin.

Medtronic and other top industry players are racing to develop the first such system, or artificial pancreas, which would be extremely lucrative for two simple reasons: First, each artificial pancreas system could cost around $10,000.  Second, millions of people around the world suffer from diabetes and the number is likely to rise as more developing nations adopt the U.S.’ signature high-calorie, low-exercise lifestyle.

Medtronic’s strategy is to roll out gradual improvements to Revel until it becomes a fully closed-loop system. The next step is to develop a system that can automatically shut down insulin therapy for two hours if blood sugar levels fall too low. Then the company will create a system that maintains a specific glucose range followed by a system that works independently at night and, finally, day.

MiniMed Paradigm® REAL-Time Revel™ System