Healthcare Industry News: LifeScan
News Release - September 8, 2008
Major Study Reinforces the Power of Medtronic Device for Better Diabetes ManagementPersonal Continuous Glucose Monitoring Further Validated by Independent Study Published in the New England Journal of Medicine
MINNEAPOLIS--(HSMN NewsFeed)--Results of the largest ever Continuous Glucose Monitoring (CGM) study were published online today by the New England Journal of Medicine. The study demonstrated that Personal CGM therapy significantly reduced the average blood glucose levels (A1c) of adult patients with type 1 diabetes, validating the growing body of clinical evidence in support of Personal CGM therapy and its ability to substantially improve diabetes management and glucose control. Studies have shown that reducing A1c can result in reduced risk of long-term side effects associated with diabetes, including blindness and kidney disease.
The multicenter, 322-patient trial, funded by the Juvenile Diabetes Research Foundation (JDRF), found that after six months adults using Personal CGM realized a statistically significant 0.53 percent absolute reduction in A1c as compared to the control group. All patients in the study experienced statistically significant absolute reductions in A1c levels ranging from 0.5 to 0.7 percent when Personal CGM was used at least six days a week. Moreover, improvements in A1c occurred without an increase in severe hypoglycemia (low blood sugar).
“Medtronic applauds the JDRF for funding studies that will build on the growing body of evidence in support of Personal CGM therapy to improve diabetes outcomes,” said Chris O’Connell, president of the Diabetes business at Medtronic, Inc (NYSE:MDT ). “This study emphasizes that patients can achieve greater diabetes control without the fear of increased hypoglycemia risk. Advanced diabetes management solutions like Personal CGM are revolutionizing diabetes therapy, and Medtronic is proud to partner with the JDRF and other diabetes organizations in support of all efforts to improve patient outcomes.”
In addition to successfully meeting statistical significance for the primary endpoint of absolute A1c reduction, the adult cohort in the study – patients 25 to 72 years old – also successfully met all secondary endpoints with statistical significance (including A1c of less than 7.0 percent, A1c of less than 7.0 percent with no severe hypoglycemia, greater than 10.0 percent relative reduction in A1c and greater than 0.5 percent absolute reduction in A1c).
Younger patient populations did not see a statistically significant reduction in A1c. However, patients in those study arms used the Personal CGM device less often than prescribed (50 percent of the time or less). All patients, regardless of their age, experienced A1c reductions when they used the device at least six days a week. The most compliant study arm – adults 25 to 72 years old – used the device more than 85 percent of the time and subsequently saw the greatest improvement in A1c. These findings expand upon the results of previous studies – like the Star 1 Study – demonstrating that more consistent use of Personal CGM results in more significant reductions in A1c.
Significant Unmet Need
Despite the growing body of evidence in support of Personal CGM, the vast majority of type 1 patients who could benefit from this therapy do not have access to it. A major reason for this discrepancy is the lack of widespread health insurance reimbursement. Medtronic has always supported the pursuit of strong clinical evidence to demonstrate the need for advanced diabetes management therapies like Personal CGM, and the company believes that this study will benefit efforts to secure insurance reimbursement for appropriate candidates.
“We are confident that the JDRF study results will aid physicians’ efforts to bring Personal CGM to more patients,” said O’Connell. “In fact, healthcare insurers are already seeing value in this technology. Many have policies for Personal CGM devices, and new coverage decisions are being made regularly.”
Medtronic currently markets the world's only integrated diabetes management system that combines Personal CGM with insulin pump therapy, the MiniMed Paradigm® REAL-Time System. Medtronic also offers a unique stand-alone Personal CGM device – the Guardian® REAL-Time System.
Products and supplies used in the JDRF CGM Study were donated by or purchased at a discounted rate from Medtronic, Inc., Abbott Diabetes Care, DexCom and LifeScan, Inc. Subjects were allowed to choose from any manufacturer.
About the Diabetes Business at Medtronic
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.
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.
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 25, 2008. Actual results may differ materially from anticipated results.
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