Medtronic has announced that the results of the in-clinic ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study met its efficacy endpoints and showed a 19% reduction in time spent below the low glucose threshold in patients using the MiniMed Paradigm System featuring Low Glucose Suspend automation, compared to conventional pump therapy. The low glucose suspend (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 Paradigm® Veo™ System featuring low glucose suspend is commercially available outside the United States but limited to investigational use in the U.S.
The ASPIRE study showed that people with diabetes using the MiniMed Paradigm System featuring Low Glucose Suspend 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).
Hypoglycemia can be one of the most frightening aspects of living with diabetes because it can result in confusion, unresponsiveness, loss of consciousness, coma and – in rare cases – even death. Research has indicated that, on average, a person with diabetes will experience more than one low blood glucose event every two weeks. In addition, each year nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycemia.
The ASPIRE study results have been published online and in the March edition of Diabetes Technology & Therapeutics.