New Insulin Pump Reduces Risk of Nighttime Hypoglycemia for Individuals with Diabetes

A new study based on a novel insulin pump feature produced by Medtronic, Inc. shows that it safely reduces nighttime hypoglycemia without affecting HbA1C levels, a measurement indicative of a person's average blood glucose control.

The Threshold Suspend, as it's called, represents a first-of-its-kind automated insulin pump capable of stopping insulin delivery temporarily when glucose values reach a pre-set low level.

"Hypoglycemia can be catastrophic for people with diabetes, especially at night when patients are likely to be unaware of symptoms because they are asleep," said Dr. Richard M. Bergenstal, executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis and past president of medicine and science, American Diabetes Association.

The effects of hypoglycemia can range from dizziness and seizures to coma and death.

The study, he further explained, is an important step in proving that the new feature can reduce the dangerous condition without increasing long-term complications - a necessary step for entrance into the U.S. market.

Conducted under an investigational device exemption (IDE) granted by the FDA, the study, entitled ASPIRE, compared two MiniMed pumps - one with the Threshold Suspend feature and one without - randomly assigned to 247 patients with type 1 diabetes and documented nocturnal hypoglycemia.

The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events, which is a standard way to summarize the magnitude and duration of hypoglycemic events.

After three months of research, scientists found that the mean AUC for nocturnal hypoglycemic events was 37.5 percent lower in the Threshold Suspend group, occurring nearly 32 percent less frequently and leading to a 31.4 percent decrease in events combined for both day and nighttime.

Furthermore, there was no change in the HbA1C in either group and no serious adverse events occurring in the those trying the new automated feature.

"ASPIRE In-Home met both its safety and efficacy endpoints and it provides additional clinical validation for Threshold Suspend, the first diabetes technology to automatically take action based on sensor glucose values," said Dr. Francine Kaufman, vice president of global medical affairs of the diabetes business at Medtronic. "The study results are important as we continue to move toward our goal of developing a fully automated system, or artificial pancreas, that will one day require very minimal interaction from the patient."

And most importantly, according to those at Medtronic, the success of the new feature puts the company another milestone closer to their expressed end goal of a fully automated artificial pancreas for those living with diabetes.