How to upgrade to the MiniMed™ 780G system

MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ 4 Sensor

The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven 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^™ 780G System includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose 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^™ 780G System consists of the following devices: MiniMed^™ 780G Insulin Pump, the Guardian^™ 4 Transmitter, the Guardian^™ 4 Sensor, One-press serter, the Accu-Chek^™ Guide Link blood glucose meter, and the Accu-Chek^™ Guide Test Strips. The system requires a prescription from a healthcare professional.

The Guardian^™ 4 Sensor is intended for use with the MiniMed^™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ (4) sensor is indicated for up to seven days of continuous use. 

The Guardian^™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ 4 sensor. The Guardian^™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. 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 https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library.

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 values (SG) 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 https://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library