Medtronic received the go-ahead to begin an at-home U.S. trial of its Low Glucose Suspend technology that aims to prevent hypoglycemia by automatically stopping basal insulin delivery when measured glucose reaches a critically low level.
The pump technology is already available in Europe on the company’s Paradigm Veo insulin pump.
This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) 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.
“FDA review of the ASPIRE IDE application was conducted through an interactive review process that involved frequent communication with the FDA review team, allowing issues to be resolved quickly and avoiding any unnecessary delays during the review. We appreciate the valuable input provided by members of the FDA’s Artificial Pancreas Working Group,” added Dr. Kaufman.