FDA Grants Medtronic Approval to Conduct In-Home Study of Insulin Pump with Low Glucose Suspend

October 28, 2011

The U.S. Food and Drug Administration (FDA) has  given Medtronic approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE (Automation to Simulate Pancreatic InsulinREsponse) study of the MiniMed Paradigm® System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for type 1 diabetes management. 

This is the second phase of the ASPIRE study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic’s newest continuous glucose sensor, the Enlite™ sensor, will be tested as part of the overall system.

ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF in the actual use environment and by the intended use population with type 1 diabetes. The first study objective is to demonstrate that home use of LGS is safe and is not associated with glycemic deterioration, as measured by a change in HbA1C. The second study objective is to demonstrate that home use of LGS is associated with a reduction in nocturnal hypoglycemia when patients fail to respond.  Hypoglycemia is a common occurrence and concern in diabetes management and can result in confusion, unresponsiveness and — in severe cases — even death.

Medtronic’s MiniMed Paradigm® REAL-Time Revel™ System, currently available in the United States, is the second generation of the only insulin pump integrated with continuous glucose monitoring (CGM) cleared by the FDA. With the addition of LGS, Medtronic has designed a first-of-its-kind semi-closed loop system that not only features insulin delivery and CGM, but also advanced software algorithms that enable the Low Glucose Suspend automation.  Low Glucose Suspend works by automatically suspending basal insulin delivery temporarily if glucose levels become too low as defined by the patient and his or her healthcare provider. It is a feature available commercially in Medtronic’s Paradigm® Veo™ System in more than 50 countries outside of the United States. The CGM-integrated system and Low Glucose Suspend automation are the first key steps towards the creation of an artificial pancreas. 

Hypoglycemia can be one of the most frightening aspects of living with diabetes. Research has indicated that, on average, a person with diabetes will experience more than one low blood glucose event every two weeks. In addition, each year nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycemia.

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