Medtronic has reported positive efficacy results for its MiniMed Paradigm Real-Time Revel system from the in-clinic Automation to Simulate Pancreatic Insulin Response (ASPIRE) study.
The FDA-approved MiniMed Paradigm system integrates the insulin pump, continuous glucose monitoring (CGM) and therapy management software.
The MiniMed revel system, featuring low glucose suspend (LGS) automation, works by automatically suspending insulin delivery if the sensor glucose value is equal to or below the low threshold value.
The ASPIRE trial is a multicentre randomised investigational device exemption (IDE) study, designed to evaluate the efficacy of the MiniMed Paradigm system low glucose suspend function in reducing the duration and severity of hypoglycemia.
The MiniMed Paradigm system met its efficacy endpoints and showed a 19% reduction in time spent below the low glucose threshold in diabetic patients in the study. The study group's average drop in blood glucose values also remained higher compared to patients using conventional insulin pumps.
Medtronic chief medical officer and Global Clinical Affairs for the Diabetes business vice president Francine Kaufman said achieving the endpoints of the in-clinic ASPIRE study will aid FDA approval and bring low glucose suspend 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 commercialise an artificial pancreas," Kaufman added.
Currently, the Paradigm system, which is commercially available outside the US, is limited to investigational use in the US. With the addition of LGS, Medtronic has designed a semi-closed loop system, which is available commercially as Paradigm Veo system in more than 50 countries outside the US.
Headquartered in Minneapolis, US, Medtronic offers medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Image: Medtronic World Headquarters, Fridley, Minnesota. Photo: Bobak Ha'Eri.