Medtronic has enrolled first patient as part of the Aspire (Automation to Simulate Pancreatic Insulin Response) study of the MiniMed Paradigm x54 System featuring low glucose suspend automation.
Aspire is a multi-center, randomized, investigational device exemption (IDE) study designed to assess the efficacy of the MiniMed Paradigm x54 System low glucose suspend function in reducing the duration and severity of hypoglycemia (low blood glucose).
Low glucose suspend is a feature available commercially in Medtronic’s Paradigm Veo System in more than 35 countries outside of US. It works by automatically suspending insulin delivery temporarily if patients’s blood glucose levels become too low.
Medtronic said that its MiniMed Paradigm Real-Time Revel system is the integrated insulin pump with continuous glucose monitoring system cleared by the FDA. With this the company has designed a semi-closed loop system that not only features insulin delivery and CGM sensors, but also advanced software algorithms that enable the low glucose suspend automation.
The integrated system and low glucose suspend automation are the first key steps towards the creation of an artificial pancreas.
Satish Garg, professor of medicine and pediatrics at Barbara Davis Center for Childhood Diabetes, said: “The new low glucose suspend integrated system is intended to close the treatment loop, ultimately reducing the risk of hypoglycemia even when a person is asleep or unable to react.”
Katie Szyman, president of the diabetes business and senior vice president at Medtronic, said: “The commencement of the Aspire study is the result of extensive interaction between Medtronic and the FDA to identify the clinical data required for FDA approval of our low glucose suspend integrated system, an innovation we believe has the potential to transform the way diabetes is managed.
“Building on our commercial success with the Veo in Europe, we look forward to the opportunity of bringing yet another new and important ‘first’ to US patients for whom hypoglycemia is a significant and constant concern.”