Medtronic plc, the global leader in medical technology, announced the US commercial launch of its MiniMed 630G system with SmartGuard technology FDA approved for the treatment of people with diabetes mellitus sixteen years of age and older. The MiniMed 630G features a new insulin pump hardware platform and new user-friendly design that combines personalized diabetes management with industry-leading clinical performance. The MiniMed 630G system is the newest member of the MiniMed family-the most prescribed integrated insulin delivery system brand in the world.
After interviewing more than 1,000 people with diabetes and testing user-experience, the enhanced features of the MiniMed 630G system were finalized to take into account what matters most to those with diabetes. This collaborative process with the patient community resulted in a new, user-friendly pump design that is waterproof, has remote bolus functionality, and features a high-definition, full-color screen that supports easy navigation and enables increased customization with more intuitive menus.
The MiniMed 630G system exclusively uses the Contour Next Link 2.4 blood glucose meter from Ascensia Diabetes Care to provide blood glucose test results that have been shown to be highly accurate. The meter automatically transmits blood glucose results to calculate boluses using the Bolus Wizard calculator and to calibrate the CGM sensor, which helps prevent manual entry errors. It also allows patients to discreetly give themselves a bolus of insulin remotely from the meter, providing added convenience to help patients manage their diabetes effectively.
"This latest innovation demonstrates Medtronic's vision to transform diabetes care to enable greater freedom and better health through a commitment to continually improving both outcomes and user experience," said Alejandro Galindo, president of the Intensive Insulin Management business at Medtronic.
The MiniMed 630G system combines its proprietary SmartGuard technology featured in the MiniMed 530G system with a brand new user-friendly design. The new pump platform fully integrates continuous glucose monitoring (CGM) and SmartGuard technology, which is designed to trigger an alarm when the CGM sensor glucose level reaches a preset low threshold and suspends insulin delivery if the user is unresponsive to the alarm. SmartGuard technology is the only feature available in the U.S. that takes action against lows, and is the only system proven to reduce the frequency of nighttime low episodes by a third.
Data from the ASPIRE In-Home Study published in the New England Journal of Medicine, demonstrated that SmartGuard technology not only reduces the number of low events per week by 30 percent but also shortens the length/intensity of those events at night by 37.5 percent without increasing A1C (a measure of average blood sugar levels over three months). These results were validated with real-world data from the company's CareLink Personal software that included an analysis of 3,770,311 days of patient data, which demonstrated SmartGuard technology users experience about half as many nighttime lows than those using a pump and sensor alone. MiniMed integrated insulin pump therapy with CGM has also been proven to provide better glucose control than multiple daily injections without increasing hypoglycemia (low blood sugar).
"Low blood sugar at night is of particular concern, when up to 75 percent of severe hypoglycemia occurs and patients are unlikely to be aware of symptoms while they are asleep," said Satish Garg, M.D., Editor-in-Chief of Diabetes Technology and therapeutics and professor of pediatrics and medicine and director of the adult diabetes program at the University of Colorado Denver, Barbara Davis Center for Childhood Diabetes. "The ability to automate the suspension of insulin at night is an important feature as prolonged hypoglycemia could be life-threatening."