MiniMed™ 780G System - Focus on your life, not your levels

IMPORTANT SAFETY INFORMATION

The MiniMed™ 780G system is intended for the 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 and is indicated for use by patients age 7 to 80 years, whose total daily dose of insulin is 8 units per day or more. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed ™ 780G system includes SmartGuard™ technology, which can be programmed to provide an automatic adjustment of insulin delivery based on continuous glucose monitoring (CGM) and can suspend the delivery of insulin when the sensor glucose value falls below, or is predicted to fall below, predefined threshold values. The system requires a prescription.

The Medtronic MiniMed™ 780G system consists of the following devices: MiniMed™ 780G Insulin Pump, the Guardian™ Link (3) Transmitter, the Guardian™ Sensor (3), One-press Serter, and the Accu‑Chek® Guide Link meter. The Guardian ™ Sensor (3) is intended to detect trends and track patterns, and for use by the MiniMed™ 780G system to adjust basal insulin rates and provide auto correction boluses while the SmartGuard™ feature is active. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site (palm) or from a control solution test. Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or 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™ 780G system has not been studied in pregnant women.


Warning: When the MiniMed™ 780G system is not using the SmartGuard™ feature, pump functions are operating in manual mode.
In manual mode, the sensor glucose readings from Guardian™ Sensor 3 are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick/BG meter reading may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian™ Sensor 3 in manual mode.