I am thrilled to announce the U.S. launch of the MiniMed 630G system with SmartGuard technology – our most advanced pump platform for people with diabetes in the country. This latest innovation was developed through a collaborative process with the patient community, who provided feedback on features that matter most to people with diabetes. This patient-centered design process resulted in a new, user-friendly pump that is waterproof, has remote bolus functionality, and features a high-definition, full-color screen. This means people with diabetes can spend less time managing their diabetes, and more time doing what they love.
As a company, we are committed to developing the world’s most advanced diabetes solutions to help people better manage their diabetes, and achieve the best outcome with the least burden. Our MiniMed family of pumps continues to be the most prescribed integrated insulin delivery system brand in the world and we are pleased to be able to introduce this latest addition to further demonstrate this commitment.
The MiniMed 630G system builds on our previous-generation MiniMed 530G system by combining our proprietary SmartGuard technology with a completely new user-friendly hardware platform. To inform the design, we interviewed more than 1,000 people with diabetes and tested user-experience to ensure we were addressing the needs of users.
Our newest innovation combines personalized diabetes management with industry-leading clinical performance with SmartGuard technology – the only feature in the U.S. that takes action to prevent lows. This unique feature has not only demonstrated that it reduces the number of low events1 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).2,3 We understand the challenges people with diabetes face managing blood sugar levels at night – particularly when they’re asleep – so this technology was developed with that need in mind.
We’re very proud to be able to introduce a system that reflects the feedback of people in the diabetes community, and this is just one of many products planned for commercialization that demonstrate our commitment to patient-centered innovation.
1 < 65 mg/dL, measured in sensor glucose values.
2 Based upon limited sample size and duration of ASPIRE In-Home study.
3 Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010;363:311-320.
IMPORTANT SAFETY INFORMATION
The MiniMed 630G system with SmartGuard™ is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 630G system includes SmartGuard, which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.
The MiniMed 630G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 630G system.
The MiniMed 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the SmartGuard suspend on low alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.
WARNING: Do not use the suspend on low feature to prevent or treat low glucose. The suspend on low feature is designed to suspend insulin delivery when you are unable to respond to the suspend on low alarm. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional. Using suspend on low to prevent or treat low glucose may result in prolonged hypoglycemia.
Please visit www.medtronicdiabetes.com/importantsafetyinformation for more details.
Tags: automated technologies
, continuous glucose monitoring
, diabetes management
, glucose control
, insulin pump
, MiniMed 530G system
, MiniMed 630G system
, SmartGuard technology
, Threshold Suspend