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|Medtronic Insulin Pump with Threshold Suspend Reported to Safely Reduce Nocturnal Hypoglycemia Without Increasing A1C|
ASPIRE In-Home Study Published in New England Journal of Medicine and Presented at American Diabetes Association Annual Scientific Sessions
CHICAGO - June 22, 2013 - Study results published today in the New England Journal of Medicine and to be presented at the American Diabetes Association (ADA) 73rd Scientific Sessions report that the Threshold Suspend feature of a sensor-augmented insulin pump from Medtronic, Inc. (NYSE: MDT) safely reduces nocturnal hypoglycemia without affecting glycated hemoglobin level (HbA1C). Threshold Suspend - a first-of-its-kind automated insulin pump feature unique to an investigational MiniMed® integrated system - automatically suspends insulin delivery temporarily when sensor glucose values reach a pre-set low level. It is also an important step toward Medtronic's ultimate goal to develop a fully automated artificial pancreas for people with diabetes.
"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 Richard M. Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis and past president of medicine and science, American Diabetes Association. "These data are very important because they provide strong evidence that sensor-augmented insulin pump therapy with a Threshold Suspend feature can reduce hypoglycemia at home - and it can do it safely, without increasing the patients' risk for long-term complications by raising their A1C."
Under an investigational device exemption (IDE) granted by the FDA, the ASPIRE In-Home study compared two MiniMed sensor-augmented insulin pumps (integrated insulin pump with continuous glucose monitoring): one with the Threshold Suspend feature and one without. While a MiniMed integrated insulin pump with continuous glucose monitoring has been proven to provide better glucose control than multiple daily injections without increasing hypoglycemia, this is the first, large in-home study to show the results of the integrated system when Threshold Suspend is incorporated.
"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 Francine Kaufman, M.D., 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."
Summary of New England Journal of Medicine Publication
In addition, the ASPIRE In-Home: Rationale, Design, and Methods of a Study to Evaluate the Safety and Efficacy of Automatic Insulin Suspension for Nocturnal Hypoglycemia will be online on June 23, 2013 by Journal of Diabetes Science and Technology.
About Threshold Suspend
To view a larger image of the MiniMed integrated system, click here.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Automation to Simulate Pancreatic Insulin REsponse
 Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010;363:311-320.
 The mean AUC of nocturnal hypoglycemia was 37.5% lower in the Threshold Suspend Group than the Control Group (980±1200 vs. 1568±1995 mg/dL x min, respectively, p<.001)
 Nocturnal hypoglycemic events occurred 31.8% less frequently in the threshold-suspend group than in the control group (1.5±1.0 vs 2.2±1.3 per patient-week, P<0.001)
 The mean AUC of day and night hypoglycemia events was 31.4% lower in the Threshold Suspend Group than the Control Group (798±965 vs. 1164±1590, p<.001
 Four patients in the Control Group had a severe hypoglycemia event.