Thursday, November 10, 2011
Medtronic, Inc. last week announced U.S. Food and Drug Administration approval of an investigational device exemption protocol to conduct an in-home clinical trial for the ASPIRE 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. Low Glucose Suspend works by automatically suspending basal insulin delivery temporarily if glucose levels become too low.
