Medtronic has presented the results of the in-clinic Automation to Simulate Pancreatic Insulin REsponse (ASPIRE) study.
The multi-center, randomized, investigational device exemption (IDE) study was designed to evaluate the efficacy of the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) function in reducing the duration and severity of hypoglycemia.
The study met the efficacy endpoints and showed a 19% reduction in time spent below the low glucose threshold in patients using the MiniMed Paradigm System featuring LGS automation, compared to conventional pump therapy.
Medtronic diabetes business global clinical affairs CMO and vice president Francine Kaufman said achieving the endpoints of the in-clinic ASPIRE study is an important milestone toward the US Food and Drug Administration (FDA) approval and bringing LGS technology to the US market.
"We are excited about this first step and are committed to advancing the insulin delivery, sensor technology, and closed loop algorithms to commercialize an artificial pancreas," Kaufman added.
The LGS feature of the integrated insulin pump and continuous glucose monitor works by automatically suspending insulin delivery if the sensor glucose value is equal to or below the low threshold value.
The company said it has presented the ASPIRE study results, which were published online, in the March edition of Diabetes Technology & Therapeutics