MiniMed 780G System – P160017/S091
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: MiniMed 780G System
PMA Applicant: Medtronic MiniMed, Inc.
Address: 18000 Devonshire Street
Northridge, CA, 91325
Approval Date: April 21, 2023
Approval Letter: Approval Order
What is it?
The Medtronic MiniMed 780G System is an automated insulin delivery system that helps people ages 7 and older manage their diabetes by detecting trends and tracking patterns in glucose levels through continuous monitoring, then using an insulin pump to automatically deliver insulin, and adjust the amount of insulin delivered, as needed.
How does it work?
The MiniMed 780G glucose sensor wire is inserted under the skin on the abdomen to measure glucose values in the body’s tissue fluid. Glucose values are sent wirelessly using Bluetooth low energy (BLE) to the insulin pump and displayed along with glucose trend information, alerts, and alarms on the pump screen. The insulin pump delivers a calculated dose of insulin through an infusion set.
The MiniMed 780G System can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels. People with diabetes can use the glucose information from the continuous glucose monitoring to see patterns in their glucose levels and use the insulin delivered from the pump to help keep glucose at safe levels.
The system provides additional diabetes management assistance by automatically adjusting insulin delivery based on changes in glucose levels. When used along with a blood glucose meter for more accurate readings of actual glucose levels, which can help users make long-term adjustments to their treatment plans with the goal of keeping glucose levels in a safe range.
When is it used?
The Medtronic MiniMed 780G system is intended to continuously measure glucose levels and automatically adjust the amount of insulin delivered to manage type 1 diabetes mellitus in adults and children 7 years of age and older. The system requires a prescription.
The continuous glucose monitoring component of the MiniMed 780G System is not intended to be used directly for making manual insulin therapy adjustments. Instead, it provides an indication of when a blood glucose measurement should be taken.
What will it accomplish?
Data from a clinical trial and real-world evidence showed that MiniMed 780G System is safe for use in children and adults 7 years of age and older who have type 1 diabetes. The clinical trial included 329 participants between the ages of 7 and 75 with type 1 diabetes who used the Advanced Hybrid Closed Loop algorithm and the Guardian Sensor 3 with the insulin pump.
Real-world evidence came from a continued access study with 176 participants, including people whose use of the MiniMed 780G System was their first experience with a hybrid closed loop system, as well as people who had previous experience with the Advanced Hybrid Closed Loop algorithm through prior use of the MiniMed780G System with Guardian Sensor 3 and/or Guardian 4 Sensor.
When should it not be used?
The MiniMed 780G System should not be used by:
- People who can’t see, hear, or recognize pump signals, alerts, or alarms.
- People who are unwilling or unable to stay in contact with their healthcare provider.
Additionally:
- Do not use the MiniMed 780G System near x-ray, magnetic resonance imaging (MRI), diathermy, or computed tomography (CT) scan equipment. Remove the pump, sensor, transmitter, and meter before entering a room that includes this equipment.
- Do not expose the pump to a magnet, including any pump cases with a magnetic clasp.
Additional information (including warnings, precautions, and adverse events):