Medtronic is reporting successful results from an in-clinic study of its the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) in diabetics who are subject to having bouts of hypoglycemia.
Low Glucose Suspend technology was developed to prevent hypoglycemia by automatically stopping basal insulin infusion when a patient’s glucose reading reaches a critically low level.
Some details of the study results from Medtronic’s announcement:
The ASPIRE study showed that people with diabetes using the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation spent less time below 70 mg/dL – the low glucose value at which insulin was suspended. In addition, the study group’s average drop in blood glucose values remained higher compared to patients using conventional insulin pumps (mean nadir YSI 59.5 – 5.72 vs. 57.6 – 5.69 mg/dL, p=0.015). In addition, the LGS suspension did not result in rebound hyperglycemia (high blood sugar). Over half of the glucose values with LGS-ON at the end of observation were in the normal range (70-180 mg/dL) and none were in the hyperglycemic range (>250 mg/dL).
ASPIRE, sponsored by Medtronic, is a multi-center, randomized, investigational device exemption (IDE) study designed to assess the efficacy of the MiniMed Paradigm System Low Glucose Suspend function in reducing the duration and severity of hypoglycemia. Subjects fasted overnight and exercised until their venous glucose value was <70 mg/dL. The in-home phase of ASPIRE is now enrolling.
Medtronic’s MiniMed Paradigm® REAL-Time Revel™ System, currently available in the United States, is the second generation of the only insulin pump integrated with continuous glucose monitoring (CGM) approved by the FDA. With the addition of LGS, Medtronic has designed a first-of-its-kind semi-closed loop system, which is available commercially in the Paradigm® Veo™ System in more than 50 countries outside of the United States.
Press release: Study of Next Step Toward Artificial Pancreas From Medtronic Meets Efficacy Endpoints
Abstract in Diabetes Technology & Therapeutics: Reduction in Duration of Hypoglycemia by Automatic Suspension of Insulin Delivery: The In-Clinic ASPIRE Study
