A study recently published online in the New England Journal of Medicine showed a significant reduction in nocturnal hypoglycemia in people with type 1 diabetes who were using an integrated insulin pump and continuous glucose monitoring system that automatically shut off when it detected preset low glucose levels.
The trial, conducted at 19 research sites across the country, including the Naomi Berrie Diabetes Center, was funded by Medtronic Inc to test its MiniMed insulin pump with Threshold Suspend, what it calls the automatic shut-off feature built in to the device. Participants in the in-home trial called ASPIRE (Automation to Simulate Pancreatic Insulin Response) were randomly assigned the MiniMed insulin pump either with or without Threshold Suspend.
Ellen Greenberg, the lead research coordinator for type 1 diabetes clinical trials at the Berrie Center said: “It’s an important and necessary first step toward the ultimate goal of developing a fully closed loop system where a pump and a sensor can talk to each other and adjust for low blood sugars without compromising glucose control. That’s a very good thing.”
Hypoglycemia, or low blood sugar, can be life threatening for people with type 1 diabetes, especially at night when they may be unaware of any symptoms while they sleep. The condition can result in confusion, unresponsiveness and, in severe prolonged cases, even coma or in very rare cases, death. Research has indicated that, on average, a person with diabetes will experience more than one hypoglycemic 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.
Medtronic’s MiniMed with Threshold Suspend, is a first generation artificial pancreas system currently under review by the FDA and expected to be approved sometime this year. It is already available commercially outside the United States.
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