ASPIRE In-Home Study Published in New England Journal of Medicine and Presented at American Diabetes Association Annual Scientific Sessions
Study results published in the New England Journal of Medicine and presented at the American Diabetes Association (ADA) 73rd Scientific Sessions report that using an automatic suspending of insulin feature of a sensor-augmented insulin pump from Medtronic, Inc. (NYSE: MDT) safely reduces nocturnal hypoglycemia without affecting glycated hemoglobin level (HbA1C).
Low Glucose Suspend– a first-of-its-kind automated insulin pump feature unique to the MiniMed® Veo 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 Mr. Milind R Shah, Vice President, South Asia and Managing Director, India Medtronic Private Limited.
"This data is very important because it provides strong evidence that sensor-augmented insulin pump therapy with automated insulin shut off 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 (insulin pump with integrated continuous glucose monitoring): one with insulin 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 an automated action is taken by the pump.
“ASPIRE In-Home met both its safety and efficacy endpoints and it provides additional clinical validation for Threshold Suspend and Low Glucose Suspend, the first diabetes technologies to automatically take action based on sensor glucose values,” said Joydipta Mukherjee, Diabetes Business Unit Head -South Asia at Medtronic.
“The study results are important as we continue to move toward our goal of developing a fully automated system, or artificial pancreas, which will one day require very minimal interaction from the patient.”
Dr. Vijay Viswanathan, Managing Director, M.V. Hospital for Diabetes and Diabetes Research Centre, Royapuram, Chennai, India, commented, “The efficacy of insulin pumps to manage diabetes is a well known fact but when a patient experiences hypoglycemia or low blood glucose levels, it’s essential for the pump to go on an auto –shut off mode. This is one feature that the medical fraternity was looking forward to and it seems like our wait has finally come to an end. The first-of-its-kind Low Glucose Suspend feature, exclusive to MiniMed Veo insulin pump works by suspending insulin delivery for up to two hours when an individual’s sensor glucose value reaches a preset low sensor level. Insulin delivery can be resumed by the patient at any time. With this new technology, Diabetes management even during phases of hypoglycemia will become much more simple and easy to manage”.
Summary of New England Journal of Medicine Publication..
Patients with type 1 diabetes and documented nocturnal hypoglycemia were randomly assigned to receive a sensor-augmented insulin-pump therapy with or without the Threshold Suspend feature for three months. The primary safety outcome was change in HbA1C, a measurement that shows an individual’s average blood glucose control over a three month period. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. AUC is a standard way to summarize two key parameters of hypoglycemic events – the magnitude and the duration. Reported results:
· The mean AUC for nocturnal hypoglycemic events was 37.5 percent lower in the Threshold Suspend group.
· Nocturnal hypoglycemic events occurred 31.8% 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% lower in the threshold-suspend group than in the control group.
· There was no change in HbA1C in either group.
· No serious adverse events occurred in the Threshold Suspend group.
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 Low Glucose Suspend
The first-of-its-kind Low Glucose Suspend feature, exclusive to MiniMed Veo insulin pumps, works by suspending insulin delivery for up to two hours when an individual’s sensor glucose value reaches a preset low sensor level. Once the threshold is met, the insulin pump will alarm and suspend all insulin delivery for two hours. Insulin delivery can be resumed by the patient at any time.
About Medtronic
India Medtronic Pvt. Ltd. is a wholly owned subsidiary of Medtronic, Inc. that markets, services and distributes Medtronic products in India. India Medtronic is headquartered in Mumbai, and has regional offices in Delhi, Baroda, Ahmedabad, Kolkata, Hyderabad, Kochi, Bangalore, Chennai and Pune.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.
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