Summary: 670 Q&a

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• 1 Sensor

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• IS GUARDIAN SENSOR 3 ANY SMALLER THAN THE PREVIOUS GLUCOSE SENSOR?

  Yes, Guardian Sensor 3 represents our smallest sensor yet. The volume of the Guardian Sensor 3 sensor is 80% smaller for the inserted portion as compared to the Enlite sensor.

• WHAT CAN I DO SO THAT I DO NOT GET ADDITIONAL CALIBRATIONS REQUESTED BY THE SYSTEM?

  The following are the reasons behind diagnostic calibrations and troubleshooting tips:
  
  • Taping: If the patient has not securely taped the sensor to his/her body, the system will detect that the sensor is straying and he/she will receive diagnostic calibration requests more frequently.
  
  • Physiology: Some people will be more prone to diagnostic calibration requests based on their unique physiology. There are no clear indicators to identify who will be more prone to receive diagnostic calibration requests.
  
  • Inconsistent calibration schedule: To ensure best possible sensor accuracy, it is recommended that the patient calibrates at consistent intervals throughout the sensor lifetime.

• WHICH SYSTEMS IS IT COMPATIBLE AND NOT COMPATIBLE WITH?

  Guardian Sensor 3 is only labeled for use with:
  
  ▪ MiniMed 670G system with Guardian Link 3 transmitter
  
  Guardian Sensor 3 is NOT labeled for use with:
  
  ▪ MiniMed® Paradigm pump systems ( 523/723, Revel and MiniMed 530G) and MiniLink transmitter
  ▪ MiniMed 630G System and Guardian Link transmitter 
  
  ▪ There is a lock out feature on Guardian Sensor 3 and Guardian Link 3 to only allow our newest and most advanced CGM technology to work with the MiniMed 670G system.
  
  ▪ The Guardian Sensor 3 CGM system uses a Radio Frequency (RF) communication protocol that is not compatible with the Paradigm pump platform.

• I’VE MIXED UP MY NEW AND OLD (ENLITE) SENSORS. HOW CAN I TELL WHICH ONE I’M SUPPOSED TO USE FOR MY MINIMED 670G?

  The MiniMed 670G system only works with the Guardian Sensor 3 and Guardian Link 3 transmitter and will not communicate with the Enlite sensor and Guardian Link transmitter. Page | 14 For Internal Use Only | No External Distribution | 940M16364-011 20170117 You can identify the right sensor by looking at the sensor box label as shown below. Also the individual sensor packaging includes a series of numbers on the back. The product number MMT- 7020 represents the correct sensor for your MiniMed 670G system. Please only use these sensors with your new pump.

• WILL THE NEW SENSOR ALLOW FOR DOSING OFF OF CGM READINGS LIKE PATIENTS NOW CAN WITH DEXCOM?

  Guardian Sensor 3 is the only sensor that has been approved for automated insulin dosing system without user interaction. While the system requires confirmatory fingersticks prior to meals, unlike Dexcom, the MiniMed 670G system with the Guardian Sensor 3 is able to keep sensor glucose levels in range automatically.
  
  Dexcom’s dosing claim does not simplify diabetes management, rather it further complicates it. Per Dexcom’s published guidelines, the patient is asked to use different trend arrows to adjust bolus estimates. It is complicated with lots of mental math and memorizing trend arrows, creating greater mental burden.

• IS THERE A CLINICAL REFERENCE FOR THE OTHER MARDS RECENTLY SHARED WHICH DO NOT CORRESPOND WITH THE PUBLISHED JAMA MARD OF 10.3%?

  The overall Mean Absolute Relative Difference (MARD) between the sensor and the reference YSI values is 10.5% with median ARD of 7.7%, with minimum calibrations (every 12 hours). Calibrating three to four times a day results in a MARD improvement of approximately 0.9%2 ( MARD = 9.64%).

• CAN THE GUARDIAN SENSOR 3 BE USED BY PEDIATRIC PATIENTS?

  The Guardian Sensor 3 is labeled for age 14 and above with the MiniMed 670G system. It is not labeled for use with other products.

• HOW DOES THE GUARDIAN SENSOR 3 ACCURACY COMPARE TO MY BG METER ACCURACY?

  Guardian Sensor 3 accuracy is measured by MARD and when used with MiniMed 670G System and 3-4 calibrations per day is 9.64%4 . Additional information on sensor performance can be found in our user manuals.
  
  Blood Glucose meter accuracy is reported in the manufacturer’s user guide. For more information on your meter’s measurement, please refer to your user guide.

• WHERE IS THE NEW ENZYME OF THE SENSOR PLACED PHYSICALLY ON THE SENSOR?

  Guardian sensor 3 includes major design improvements, including new enzyme coating, that led to the improved accuracy and performance.
  
  The following are the major improvements:
  
  1. New sensor electrode coating – new enzyme coating used to improve stability and sensitivity
  
  2. Selective enzyme deposition – implemented to improve sensor performance and longevity

• HAS DAY 1 PERFORMANCE IMPROVED FOR THE GUARDIAN SENSOR 3? IF SO, HOW WAS THIS ACCOMPLISHED?

  Yes, day 1 performance has improved. Day 1 MARD for Enlite was 13.0%, and has been improved to 11.7% for Guardian Sensor 3.
  
  This has been accomplished through changes to the sensor design and the new sensor calibration algorithm. For example, the sensor calibration algorithm has a new compensation feature specifically focused on day 1 performance. This same feature may request a diagnostic calibration for optimal performance.