Medtronic announces FDA approval for MiniMed 770G insulin pump system

We’re excited to announce the next innovation in Medtronic Diabetes technology. On September 1^st, 2020, Medtronic received FDA approval for the MiniMed^TM 770G system! This new insulin pump system builds on the MiniMed^TM 670G system, providing smartphone connectivity and an expanded age indication to ages 2 and up. 

  With the MiniMed^TM 770G system, you get the same great technology you know and love from the MiniMed^TM 670G system, but now with the ability to see your sugar levels from your (or a care partner’s) smartphone. Here’s what you can expect:

• For people on the MiniMed^TM  770G system, the MiniMed^TM  Mobile app mirrors the pump screen to allow you to see your pump and continuous glucose monitoring (CGM) data on your personal phone. You’ll also receive notifications from your system with alerts or alarms when you’re heading out of range. The MiniMed^TM  Mobile app works on both iPhone and Android devices.
   
• For care partners, the CareLink^TM  Connect app provides visibility to pump and CGM data so they can view sugar levels in real time, even when not close by. The app also allows care partners to receive text notifications if sugar levels are out of range.
   
• Smartphone connectivity allows those living with diabetes and their care partners to view insulin delivery and bolus information on their mobile device.
   
• The MiniMed^TM  770G system is also enabled for future software upgrades, once such software upgrades are available. Customers will be offered a software upgrade at no charge through December 2021.¹
   
• We’re also excited to share this new system is approved for ages 2 and older!
   
• The MiniMed^TM  770G has SmartGuard^TM  Auto Mode, which means it automatically adjusts² background insulin every five minutes, 24 hours a day, based on your unique insulin needs. The goal of this automated insulin delivery is to help maximize the time glucose levels are within the target range and to help minimize highs and lows.
   

The MiniMed^TM  770G system includes an insulin pump, a CGM system (with Guardian^TM  Sensor 3), diabetes management software (CareLink^TM  Personal software), the MiniMed^TM  Mobile app, CareLink^TM  Connect app, and a blood glucose meter (Roche Accu-Chek Guide Link meter). For more information on compatible devices, infusion sets, and other products, check out the technical specifications here. 

Watch this video below for a message from our group president. 

To learn more about the MiniMed^TM  770G system and request more information, check it out here.  The MiniMed^TM  770G system will be available for purchase in the coming months. 

¹ Program eligibility requirements and terms and conditions apply. Subject to change. 
² Refers to SmartGuard Auto Mode. Some user interaction required. Individual results may vary. 
Actor portrayal in these photos.

IMPORTANT SAFETY INFORMATION: MINIMED™ 770G SYSTEM WITH SMARTGUARD™ TECHNOLOGY

The MiniMed™ 770G system 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 type 1 diabetes mellitus in persons two 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™ 770G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose (SG) values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. 

The Medtronic MiniMed™ 770G system consists of the following devices: MiniMed™ 770G insulin pump, the Guardian™ Link (3) transmitter, the Guardian™ Sensor (3), one-press serter, the Accu-Chek^® Guide Link blood glucose meter, and the Accu-Chek^® Guide test strips. The system requires a prescription. 

The Guardian™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3). 

All therapy adjustments should be based on measurements obtained using the Accu-Chek^® Guide Link blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek^® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. 

WARNING: Do not use the MiniMed™ 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 770G system. 

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 770G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library.