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June 27, 2013
Doretta Royer 315 464-4833

Insulin pump tested at Upstate represents ‘major advance’ toward artifical pancreas

SYRACUSE, N.Y. — Upstate Medical University researchers joined diabetes researchers across the country in reporting that an investigational MiniMed® integrated insulin pump system with automatic insulin suspension safely reduced nighttime hypoglycemia for people with diabetes without increasing average blood glucose.

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 findings are the result of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) clinical trial funded by Medtronic Inc. The Upstate Joslin Diabetes Center was one of 19 U.S. sites to participate in the study whose findings were published online in The New England Journal of Medicine (NEJM) and presented at the American Diabetes Association (ADA) 73rd Scientific Sessions, held June 21 to 25 in Chicago, Ill.

Ruth Weinstock, M.D., Ph.D., served as principal investigator of Upstate’s study.

“Severe hypoglycemia is a dangerous acute complication of insulin therapy,” said Weinstock, SUNY Distinguished Service Professor of Medicine and medical director of the Upstate Joslin Diabetes Center.  “The ability of this new insulin pump and continuous glucose monitoring system to reduce hypoglycemia is a major advance.”

ASPIRE is the first, large in-home study to show the results of the integrated system when Low Glucose Threshold Suspend is incorporated. Threshold Suspend is a first-of-its-kind automated insulin pump feature. It automatically suspends insulin delivery temporarily when sensor glucose values reach a pre-set low level.  It is also an important step toward the ultimate goal to develop a fully automated artificial pancreas for people with diabetes.

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. Participating in the study were 247 patients with type 1 diabetes with documented nocturnal hypoglycemia. They were randomly assigned either a sensor augmented insulin pump with or without threshold Suspend for three months. Results, as reported in the New England Journal of Medicine, are:

• The mean AUC (area under the curve) for nocturnal hypoglycemic events was 37.5 percent lower in the Threshold Suspend group. AUC is a standard way to summarize two key parameters of hypoglycemic events – the magnitude and the duration.

•  Nocturnal hypoglycemic events occurred 31.8 percent less frequently in the Threshold Suspend group than in the control group. •  The mean AUC for combined daytime and nighttime hypoglycemic events was 31.4 percent lower in the Threshold Suspend group than in the control group.

• There was no change in HbA1C in either group. HbA1C is a laboratory test that shows the average level of blood sugar (glucose) over the previous three months. ·

• No serious adverse events occurred in the Threshold Suspend group.

Threshold Suspend is available commercially outside the United States in the MiniMed® Veo™ system (known as Low Glucose Suspend in this product). The feature is also a part of the MiniMed® 530G with Enlite, a first-generation artificial pancreas system currently under review at the FDA. Threshold Suspend works by suspending insulin delivery for up to two hours when an individual’s sensor glucose values reach a preset low level. Once the threshold is met, the insulin pump will alarm and suspend all insulin delivery for up to two hours. Insulin delivery can be resumed by the patient at any time.

Caption: Ruth Weinstock, M.D., Ph.D., right, and Clinical Research Coordinator Suzan Bzdick, R.N., with the MiniMed insulin pump.

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