Great news, everyone! Today I’m thrilled to share that the FDA has approved the MiniMed® 630G system with SmartGuard™ technology. This advanced diabetes system provides better glucose control[i], protective action and personalized management so you can focus less on managing highs and lows and more on what matters most to you –whether that’s time with your loved ones, pursuing a big career goal, traveling the world or all of the above!
What’s so exciting about the MiniMed 630G system? Let’s find out.
MiniMed 630G is a new insulin pump combined with our Enlite® sensor. The system includes SmartGuard, our exclusive technology that takes action to reduce the risk of diabetes complications ii. The system automatically stops delivering insulin when your sensor glucose hits a preset low level and you don’t respond to the alarm. SmartGuard is available in both MiniMed 630G and MiniMed 530G systems (you may recognize this as Threshold Suspend.)
A new, improved pump design
The MiniMed 630G system also has a brand new (and improved) pump design with many more personalization options to make the system more convenient and tailored to how you manage your diabetes. You can customize alerts and alarms and we’ve introduced more user-friendly menus. The new system also includes that full-color screen and waterproofing you’ve been asking us for! This new design incorporated extensive patient feedback and user testing from people with diabetes, so we can’t wait to hear what you think.
A new meter
The MiniMed 630G system exclusively uses the CONTOUR®NEXT LINK 2.4 Meter to provide highly accurate blood glucose testing and to automatically transmit blood glucose results into the pump to eliminate manual entry errors when using the Bolus Wizard® calculator or calibrating the sensor. It’s similar to the CONTOUR NEXT LINK meter that comes with our MiniMed 530G system and is the only meter FDA approved for use with the new system. It also allows you to discreetly give a manual or a pre-set bolus of insulin remotely from the meter – another feature that many of you have told us would be beneficial to you.
Just one more step
Here at Medtronic Diabetes, our vision is to transform diabetes care, together for greater freedom and better health. This new system demonstrates Medtronic’s focus on making diabetes devices more convenient and simple to use as well as delivering better clinical outcomes. We’re certainly not done yet. Innovation is a journey and we’re constantly working on improving the products we have today as well developing new ones. In the meantime, we can’t wait to hear what you think of this latest step to help you live your exceptional life.
Part of a family
The MiniMed 630G system joins our family of diabetes management products, including our MiniMed 530G system which we will continue to provide. The MiniMed 530G system is popular for its ability to be used with MiniMed Connect mobile accessory, which allows people with diabetes to discreetly view CGM data on their smartphones as well as remote monitoring for their care partners. So, we’re offering both products to meet the different lifestyle needs of people with diabetes. Like the MiniMed 530G system, the MiniMed 630G system is approved for people age 16 and older.
We expect to start shipping in a few weeks and we’ll be sure to keep our community updated. To learn more about the product in the meantime, visit our website.
Important Safety Information
The MiniMed 530G and 630G systems with SmartGuard technology are intended for the delivery of insulin and continuous glucose (CGM) monitoring for the management of diabetes mellitus in persons 16 years of age or older who require insulin. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy.
The systems are 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 Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter.
WARNING: The Threshold Suspend/Suspend on Low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend/Suspend on Low feature, it is important to read the information in the MiniMed System User Guide and discuss proper use of the feature with your healthcare provider.
A confirmatory fingerstick via a CONTOUR®NEXT LINK portfolio meter*, is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK portfolio meter*, to ensure the glucose result shown agrees with the glucose results shown on the meter. Additional, warnings, precautions and contraindications apply. See www.medtronicdiabetes.com/support/download-library/user-guides and www.medtronicdiabetes.com/importantsafetyinformation for details.
*The CONTOUR®NEXT LINK 2.4 Meter is used with the MiniMed 630G system. The CONTOUR®NEXT LINK Meter is used with the MiniMed 530G system.
[i] Bergenstal R, Tamborlane W, Ahmann A, Buse J. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. New Engl J Med. 2010;4(363):311-320
[i][i] The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993:977─986.
, MiniMed 630g