Minimed 670G System - P160017/S031
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 the FDA's approval.
Product Name: Minimed 670G System
PMA Applicant: Medtronic MiniMed, Inc.
Address: 18000 Devonshire Street, Northridge, CA, 91325
Approval Date: June 21, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017S031a.pdf
What is it? The Medtronic MiniMed 670G System is the first FDA approved hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user's glucose reading in users seven years of age years and older. This device was approved on September 28, 2016 under P160017 for users aged 14 years and older.
How does it work? The Medtronic MiniMed 670G System consists of a continuous glucose monitor (CGM) that measures the user's glucose levels for up to seven days, an insulin pump that delivers insulin to the user, and a glucose meter used to calibrate the CGM.
The MiniMed 670G System is able to decrease or stop insulin delivery when it detects the user's glucose is low, or increase the insulin delivery when the system detects the user's glucose levels are high with no input from the user. The glucose sensor contains a wire that is inserted under the skin on the abdomen and measures glucose values in the tissue fluid. The glucose values are wirelessly sent to the insulin pump, and displayed along with glucose trend information, alerts, and alarms on the pump screen. The insulin pump delivers a prescribed dosage of insulin through an infusion set. The insulin pump can automatically adjust the delivery of insulin using a mathematical equation, or algorithm that incorporates information from the CGM.
The system has two modes; Manual Mode and Auto Mode. While in Manual Mode, the system can be programmed by the user to deliver basal insulin at a preprogrammed constant rate. The system will automatically suspend delivery of insulin if the sensor glucose value falls below or is predicted to fall below a predetermined threshold. The system will also automatically resume delivery of insulin once sensor glucose values rise above or are predicted to rise above a predetermined threshold. While in Auto Mode, the system can automatically adjust basal insulin by continuously increasing, decreasing, or suspending delivery of insulin based on CGM values (different from Manual Mode where basal insulin is delivered at a constant rate). Although Auto Mode can automatically adjust basal insulin delivery without input from the user, the user must still manually deliver insulin therapy during meals.
When is it used? The Medtronic MiniMed 670G 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 seven years of age and older. The system requires a prescription.
The CGM component of the MiniMed 670G System is not intended to be used directly for making manual insulin therapy adjustments, but rather to provide an indication of when a glucose measurement should be taken.
What will it accomplish? People with diabetes can use the glucose information from the CGM to help determine patterns in their glucose levels. The MiniMed 670G 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 insulin delivered from the pump to help keep their glucose levels at a safe level. The 670G System provides additional diabetes management assistance by automatically adjusting basal insulin delivery based on changes in glucose levels. When used along with a blood glucose meter to obtain a more accurate reading of actual glucose levels, a continuous glucose monitoring and insulin pump system can also help people with diabetes make long-term adjustments to their treatment plan to keep glucose levels in a safe range.
Data supporting the approval of this device included results of a study with 123 participants with type 1 diabetes. The clinical trial included an initial two-week period where the system's hybrid closed loop was not used followed by a three-month period during which trial participants used the system's hybrid closed loop feature as frequently as possible. This clinical trial showed that the device is safe for use in persons fourteen years of age and older with type 1 diabetes
When should it not be used? The MiniMed 670G System should not be used in:
- People who require less than a total insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely
- Children under 7 years of age because the device may not be safe in children requiring less insulin.
- Anyone unable or unwilling to:
- Perform a minimum of four blood glucose tests per day.
- Maintain contact with their healthcare professional.
- Carry the Medical Emergency Card provided with the system when traveling. The Medical Emergency Card provides critical information about airport security systems, and pump usage on an airplane.
- People whose vision or hearing does not allow recognition of pump signals and alarms.
Patients should always remove their pump, sensor, transmitter, and meter before entering a room that has x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make the devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over delivery and severe hypoglycemia.
Patients should not expose their pump to a magnet, such as pump cases that have a magnetic clasp.
Patients seven to thirteen years of age should not fully rely on the use of a low sensor glucose (SG) value for "Alert on Low" or "Alert before Low" for alerts set at 50 mg/dL and 60 mg/dL. A low sensor glucose alert may not reflect the user's true blood glucose at these levels, or may not alert. Do not ignore symptoms of low glucose. Patients should always confirm their sensor glucose readings with their blood glucose meter, and treat according to the recommendations of their healthcare professional. Solely relying on these sensor glucose alerts and readings for treatment decisions could result in missing severe hypoglycemia (low blood glucose) events.
Additional information (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness Data and labeling are available online.