New device for treating hypoglycemia launched globally

Sep 3 2009

At this year’s annual meeting of the International Society for Pediatric and Adolescent Diabetes (ISPAD) in Ljubljana, Slovenia, Medtronic, Inc. (NYSE: MDT) announced the global launch of a novel technology designed to provide additional protection against the risks associated with hypoglycemia. This new device, now available in more than 50 countries outside of the United States, can automatically suspend insulin delivery when the device senses that glucose levels have fallen to or below a user-selected threshold. This feature is intended to reduce the severity of low blood sugar (hypoglycemia) in situations where patients ignore or are unable to treat hypoglycemia. A dangerous and often frequent occurrence in diabetes management, hypoglycemia can be one of the most frightening aspects of living with type 1 diabetes. If left untreated, hypoglycemia can cause loss of consciousness, seizure, coma, or even death.

Research indicates that, on average, a person with diabetes will experience more than one low blood sugar event every two weeks. Additionally, each year, nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycemia, requiring urgent treatment by a healthcare professional. A third of diabetes patients suffer from hypoglycemia while asleep, which may impair their ability to recognize or act to prevent a serious episode. An estimated 33 percent of diabetes-related deaths are a result of acute complications such as hypoglycemia. While some patients can experience “warning signs” before a hypoglycemic event (such as feeling shaky, sweating, tingling in the lips, confusion and irritability), others may not experience any warning signs at all.

“The Paradigm Veo is the biggest step thus far in our commitment to closing the loop on diabetes management,” says Chris O’Connell, president of the Diabetes business and senior vice president at Medtronic. “While not a cure for diabetes, we believe this automatic feature offers added protection, greater confidence and may lower the risk of injury associated with hypoglycemic events. Equally important, it will give patients and family members more peace of mind.”

The Paradigm Veo System includes an insulin pump with a continuous glucose monitoring (CGM) system (provided by means of a separate sensor and transmitter). The patient uses readings from the monitor in conjunction with occasional confirmatory fingerstick blood glucose measurements to understand their current glucose level. Based on these results, the patient then programs the insulin pump to deliver an appropriate amount of insulin. Insulin combats high blood sugar, a key cause of heart disease and other long-term complications in type 1 diabetes. However, if data transmitted from the sensor show the patient’s glucose levels have dropped below a defined threshold, the device alarms to alert the patient. If these alarms are ignored, the insulin pump automatically suspends insulin delivery for up to two hours. This helps to protect against potentially dangerous hypoglycemic events.

“This latest technology is a significant breakthrough that will help people with diabetes to control their condition. In order to reduce the long-term risk of diabetes-related complications, which can cause blindness, kidney failure and heart attacks, patients should manage their glucose levels to as near normal as possible. Unfortunately, aggressive glucose control can increase the risk of severe hypoglycemia, which can render a patient unconscious—and if recurrent—can have very serious consequences,” says Prof. Dr. Tadej Battelino, head of the Department of Pediatric Endocrinology at Ljubljana’s University Children’s Hospital. “For the first time, a mechanical device can now warn the patient of this dangerous situation. The Paradigm Veo alerts patients if their glucose levels drop too low, and stops the delivery of more insulin if they don’t respond to the alert. Having this safety feature may allow patients greater control over severe hypoglycemia.”

The Paradigm Veo will be launched in more than 50 countries across Europe, Asia, Africa, Canada and Latin American. Medtronic is working closely with the U.S. Food and Drug Administration (FDA) on plans to commercialize the product in the United States.