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FDA approves Medtronic MiniMed Paradigm System IDE

The US Food and Drug Administration (FDA) has approved Medtronic's Investigational Device Exemption (IDE) application to conduct clinical trial for the Automation to Simulate Pancreatic Insulin REsponse (ASPIRE) study of the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation to treat Type 1 diabetes.

The multi-center, pivotal in-home, randomized study is designed to assess the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump.

The study 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 is to show that home use of LGS is safe and is not associated with glycemic deterioration, as measured by a change in HbA1C.

The second study aims to show that home use of LGS is associated with a reduction in nocturnal hypoglycemia when patients fail to respond.