Medtronic has received an Investigation Device Exemption from the FDA to conduct the first in-home clinical trial of a closed loop system for Type 1 diabetes management.
The MiniMed Paradigm system features low glucose suspend (LGS) automation and the study represents a step forward in the development of an artificial pancreas, according to Medtronic.
The in-home clinical trial is the second phase of Medtronic’s ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of an inpatient clinical study. Medtronic’s newest glucose sensor, the Enlite sensor, will be tested with the LGS feature in the MiniMed Paradigm insulin pump in the in-home trial, according to the company. The ASPIRE study will compare hypoglycemic events with and without the LGS in a Type 1 diabetes population.
“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 company stated. “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.”