Please keep in mind that the FDA has a period for review. This process can take some time and we will provide updates when available.
Any customer using MiniMed™ 770G system will get access to future innovations, when available, at no charge through October 27, 2022.*
2020 |
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1st real-time CGM + smart^ pen (real-time MDI decision support) |
2020 |
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1st automated§ insulin pump system approved for ages 2 and up (MiniMed™ 770G system) |
2018 |
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1st stand-alone Smart* CGM with predictive alerts |
2017 |
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1st system to automatically adjust background insulin |
2016 |
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InPen launched and FDA clearance issued† |
2015 |
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1st technology to help reduce lows** |
2009 |
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1st technology to help reduce severe lows* |
2006 |
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1st system to integrate pump & CGM |
All referenced product innovations are in development or still being designed. Such innovations are not FDA-approved and will require FDA review prior to such approval.
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 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 SmartGuard™ Auto Mode for people who require less than eight units or more than 250 units of total daily insulin per day. A total daily dose of at least eight units, but no more than 250 units, is required to operate in SmartGuard™ Auto Mode.
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
The InPen requires a prescription. It is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.
For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
For additional product and important safety considerations, see User Guide and http://bit.ly/InPenSafety.
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