New Study: Investigational Artificial Pancreas Device Safely Reduced Nighttime Hypoglycemia
The Mills-Peninsula Health Services Diabetes Research Institute in San Mateo, California, was the lead site and David C. Klonoff, M.D., was study chair of a national, multicenter study called ASPIRE (Automation to Simulate Pancreatic Insulin REsponse), an in-home clinical trial of the integrated MiniMed insulin pump with automatic insulin suspension, a feature called Threshold Suspend which is unique to MiniMed insulin pump systems. The trial was conducted at multiple investigational centers across the United States to determine the safety and efficacy of Threshold Suspend.
This clinical trial is the first, large in-home study to show the results of the integrated system when Threshold Suspend is incorporated. The trial compared two MiniMed sensor-augmented insulin pumps (integrated insulin pump with continuous glucose monitoring): one with the Threshold Suspend feature and one without.
The results of the study were published online in The New England Journal of Medicine (NEJM) and were presented at the American Diabetes Association (ADA) 73rd Scientific Sessions Meeting in Chicago, June 21-25, 2013. The article, entitled, “Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia,” reports the outcomes of the first in-home pivotal trial of a closed loop product for management of type 1 diabetes.
“This was a historic study because it was the first randomized controlled trial of a commercial product for outpatients that features automatic control of insulin delivery,” Dr. Klonoff explained. “Some day when a fully automatic artificial pancreas product becomes available for patients with diabetes, we will look back to this successful study as equivalent to the Wright brothers’ flight on the path to space travel.”
Hypoglycemia, or low blood sugar, can be life-threatening for people with type 1 diabetes, especially at night when they are likely to be unaware of any symptoms while they sleep. The condition can result in confusion, unresponsiveness and — in severe prolonged cases — even coma or 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.
The trial was funded by Medtronic, Inc., world leader in advanced diabetes management solutions and the manufacturer of the integrated MiniMed insulin pump with Threshold Suspend. The study was conducted at 19 sites across the United States with participation from 247 patients with type 1 diabetes and documented nocturnal hypoglycemia. Participants were randomly assigned either a sensor augmented insulin pump with (121) or without (126) Threshold Suspend for three months.
The Medtronic Veo is approved in Europe and is currently seeking approval from FDA to be marketed in the United States. If Veo is approved, then it will be the first closed loop product on the market in the United States.
Dr. Klonoff is also an author on a methods article about the ASPIRE In -Home study that appeared in Journal of Diabetes Science and Technology in May 2013. He also serves as an editor for this bi-monthly, peer-reviewed scientific e-journal.
The Mills-Peninsula Diabetes Research Institute is a leading facility for diabetes technology research, including work on closed loop systems. When a closed loop system becomes fully automatic, like a human pancreas, then it will be known as an artificial pancreas. Dr. Klonoff is an Advisor to National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) for their artificial pancreas research programs.
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