GuardControl Study Shows Improved Glycemic Control in Type 1 Diabetes Using REAL-Time Continuous Glucose Monitoring
Largest Clinical Trial to Validate Benefit of Medtronic REAL-Time Continuous Glucose Monitoring
Minneapolis –November 27, 2006 – Data from the GuardControl Trial, the first international, large-scale, multi-center, randomized clinical outcome trial conducted to evaluate the use of Medtronic REAL-Time Continuous Glucose Monitoring (CGM) technology for improved diabetes management, was published today in Diabetes Care. The study demonstrated that patients using Medtronic REAL-Time CGM had better control of their blood glucose than patients using fingersticks only.
The 12-week international study demonstrated clinically meaningful reductions in HbA1c as early as one month, which continued for up to three months in poorly controlled patients with type 1 diabetes. Patients who monitored their glucose levels continuously using the Medtronic Guardian® RT Continuous Glucose Monitoring System experienced a one percentage point reduction in HbA1c levels, versus a 0.4 percentage point reduction in the control group using traditional intermittent blood glucose testing (fingersticks) alone. After three months of continuous use, 26 percent of patients experienced an HbA1c reduction of at least two percentage points.
“The GuardControl Trial confirms that real-time continuous glucose monitoring and alarms can positively impact diabetes management and metabolic control,” said Dr. Dorothee Deiss, diabetologist and trial investigator from Children’s Hospital Charité, Humboldt-University, Berlin, Germany. “Patients struggle constantly to maintain control over their diabetes to prevent short- and long-term complications. Now they have a clinically proven technology to get much more insight into their glycemic control, and to help them better self-manage their diabetes"
An HbA1c measurement reflects a patient’s average blood glucose control over a two-to-three month period. Clinical trials have shown that for every one percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications, and a significant reduction in healthcare costs. Maintaining near-normal blood glucose control can reduce kidney complications up to 56 percent, nerve disease up to 60 percent, eye disease up to 76 percent and cardiovascular damage by 42 percent, thereby improving health and extending life for many diabetes patients.
The study used the Medtronic Guardian RT Continuous Glucose Monitoring System. The Guardian RT System displays glucose readings every five minutes, and sounds an alarm when glucose levels reach high or low glucose limits preset by the clinical professional. This comprehensive information is extremely valuable for assessing diabetes management, and allows patients to take immediate action to improve their glucose control. Special software is designed to download glucose data to a computer where graphs can be displayed and interpreted.
Eight centers in Germany, France, Sweden, Italy, the United Kingdom, Slovenia and Israel tested a total of 162 type 1 patients (81 adult and 81 pediatric). All study participants tested their blood sugar using a traditional blood glucose meter, and were randomized into three trial arms: (the control group) self-monitoring patients using an unlimited number of fingerstick measurements from a traditional glucose meter; patients using REAL-Time CGM continuously; patients using the REAL-Time CGM for a three-day period every other week. Study participants either used an insulin pump or took three or more injections per day to administer insulin therapy.
Medtronic recently developed the next generation Guardian® REAL-Time System that will be available in select global markets this winter. The MiniMed Paradigm® REAL-Time System, the world’s first integrated insulin pump and continuous glucose monitoring system, is available in the United States and more than 20 other countries around the world.
In type 1 diabetes, the pancreas does not produce insulin, which is needed to control glucose. Insulin takes the sugar from the blood into the cells to fuel the body. Diabetes is reaching epidemic proportions worldwide. According to the International Diabetes Federation, approximately 194 million adults have diabetes worldwide, and this number is expected to reach 333 million by the year 2025. Maintaining near normal glucose levels is critical for diabetes patients wishing to live longer, healthier lives.
About the Diabetes Business at Medtronic
The diabetes business at Medtronic (www.medtronic-diabetes.com) is the world leader in diabetes management. The company’s products include insulin pump therapy, continuous glucose monitoring systems, related disposable products and diabetes management software.
Medtronic, Inc. (NYSE: MDT) (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.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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