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.
