*Investigational. Not approved by the FDA for any use and not commercially available in the US.
Those using the MiniMed™ 770G system can get access to our MiniMed™ 780G software when available, at no cost, without switching their pump. Rest assured, the software upgrade will be available to you for at least 1 year from time of MiniMed™ 780G system approval.
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.
The Extended infusion set is the first and only infusion set approved for twice the wear+, up to 7 days, which allows you to reduce the number of set changes and gives your favorite sites more time to heal.
+ Clinical evaluation document: Clinical evaluation report for the extended wear infusion set. 2019. 10937618DOC. (2) Zhang JY, et al. Advances in Insulin Pump Infusion Sets Symposium Report. Journal of Diabetes Science and Technology 2021; DOI: 10.1177/1932296821999080 (3) Ilany et al. Clinical Study of a New Extended Wear Infusion Set Diabetes. 2020;69(Supplement 1):994-P (4) Ilany J, et al. Abstract 416 - Clinical study of a new extended wear infusion set design. 13th ATTD International Conference.
February 2020
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.
The Extended Infusion Set is indicated for up to 7 days of wear for the subcutaneous infusion of insulin from an infusion pump. It is NOT indicated for intravenous (IV) infusion or the infusion of blood or blood products. Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set. If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air in the infusion set. Prime completely. Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication. If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin. Regularly replace the infusion set as indicated in the instructions for use, or per the insulin labeling, whichever duration is shorter.