FDA Approves World’s First Combo Insulin Pump And Glucose Monitor For Diabetes; Device Alerts Users When Glucose Gets Too High Or Low

For people with insulin-dependent diabetes, trying to control their blood glucose, or blood sugar, can be a stressful juggling act. Managing the disease often requires several daily insulin injections, taking up to 10 blood samples a day, coordinating the use of multiple medical devices and being mindful of how diet, exercise and medication can affect blood-sugar levels.

Medtronic’s Paradigm REAL-Time System incorporates a glucose sensor, a transmitter, a “smart” insulin pump and a glucose meter to provide patients with better control, flexibility and health.

Chris Jarvis, a member of the 2004 Canadian Olympic Rowing Team and a marathon runner, knows firsthand about the challenges associated with diabetes. He has type 1 diabetes, which means his body doesn’t produce insulin on its own. Some days, during races, Jarvis used to take up to 15 fingerstick measurements to check his blood sugar. For many years, he used two separate devices to control his diabetes, one to monitor his glucose and another to administer insulin into his body.

Most recently, however, Jarvis has been using a new federally approved device-the only one of its kind in the world-that has given him much more control over his diabetes.

Developed by Minneapolis-based medical technology company Medtronic, Inc., the MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System integrates an insulin pump and continuous glucose monitoring system to deliver insulin to the body day and night while at the same time continuously checking glucose levels, and sounding an alarm (or vibrating) if levels get dangerously high or low. This new device provides Jarvis with the confidence he needs to continue leading a healthy life.

“It gives you a real sense of comfort knowing exactly what’s happening inside of your body, rather than trying to guess with only a couple of fingersticks,” Jarvis says. “It’s just a quick touch of a button and you see where your blood sugar is.”

This new therapy option helps patients, like Jarvis, gain tighter control over their disease and understand how their diet, exercise, medication or lifestyle may affect their blood sugar. Armed with this knowledge, patients can take immediate corrective or preventive action to maintain healthy glucose levels.

Dr. Irl Hirsch, medical director, University of Washington Diabetes Care Center, Seattle, says that many patients with insulin-dependent diabetes still give themselves multiple daily injections of insulin and rely solely on blood draws-four to 10 per day-from fingersticks to measure their blood-sugar levels. The new system changes all this because it constantly delivers insulin to the body and continuously-almost 300 times a day-provides users information on what their glucose level is and whether it’s heading up or down.

“If you have insulin-dependent diabetes, you need to make sure you’re getting the right amount of insulin, and you need to keep a close eye on your glucose levels,” Hirsch says. “The insulin pump and continuous glucose monitor is a major breakthrough because it’s the only device in the world that helps you do both.”

Studies have shown that multiple daily insulin injections aren’t as effective as insulin pumps in controlling diabetes. Fingersticks alone miss more than 60 percent of low-glucose events, and that’s a real danger for people with diabetes. If blood sugar gets too high or low, patients can lapse into a coma and die within just a few hours. Over time, not maintaining normal blood-sugar levels can lead to blindness, stroke, amputations, heart disease and kidney disease.

“With the MiniMed Paradigm REAL-Time System, I control my diabetes; it doesn’t control me,” Jarvis says.