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Our most
advanced sensor,

Guardian Sensor 3.

Manage glucose levels with a smarter CGM (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3. Guardian Sensor 3 may be used as part of the MiniMed®640G system for ages 2 and up. Sensor is indicated for use on arm and abdomen.

Sensor Improvements:


MORE CONSISTENT PLATING:
  • Reduces variability and increases consistency
  • Similar to metal plating of jewelry

ELECTRODE DESIGN:
  • Improved performance
  • Increased number of electrodes allows for sensing along the entire length of sensor
  • Better distribution of the “work”; more robust

ADDITIONAL TAPE BARRIER LAYER:
  • Increased comfort, reduced skin irritation
  • Ensures maximum patch adhesion to the body
  • More comfortable to wear

Guardian Sensor 3


Conditions and MARD

Ages 7-13 Abdomen Arm
Conditions MARDª
3-4 calibrations/day 9.84%* 8.79%*
2 calibrations/day 10.46%* 9.14%*
Ages 14 and up Abdomen Arm
Conditions MARDª
3-4 calibrations/day 9.6%* 8.7%*
2 calibrations/day 10.5%* 9.1%*
Enlite Sensor Guardian Sensor 3
Available age 7 and up Available age 2 and up

Indications

The sensor is a component of Medtronic Continuous Glucose Monitoring Systems and is indicated for continuously monitoring glucose levels in persons with type 1 diabetes. The sensor is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices.

The sensor is indicated for:

  • Ages 2 or older when used as part of a system with Guardian Connect
  • Ages 2 or older when used as a part of a system with the MiniMed 640G insulin pump
  • Ages 7 or older when used as part of a system with the MiniMed 670G insulin pump

The indication for children under the age of 18 is limited to those who are supervised by a caregiver. The caregiver must be at least 18 years of age.

Warnings

Important Safety Information: Guardian® Sensor 3

The Guardian™ Sensor (3) is only intended to be used by patients (aged 2 years and older) with type 1 diabetes.

Health care professionals and consumers should be aware about the limitations of available scientific evidence for use of this device in any other groups of patients who require diabetes management.

Nevertheless it would not be unreasonable to allow the clinical data derived from type 1 diabetes to be adduced to other forms of diabetes which are truly insulin dependent or deficient, including severe insulin deficient secondary diabetes, and some with cystic fibrosis related diabetes, where the achievement of adequate glycaemic control may benefit from continuous glucose monitoring or continuous subcutaneous insulin infusion.

During times of rapidly changing glucose (more than 0.1 mmol/L (2 mg/dL) per minute), interstitial fluid glucose levels as measured by the Guardian™ Sensor (3) may not accurately reflect blood glucose levels. Under these circumstances, check the Sensor glucose readings by conducting a fingerstick test using a blood glucose meter.

In order to confirm hypoglycaemia or impending hypoglycaemia as reported by the Guardian™ Sensor (3), conduct a fingerstick test using a blood glucose meter.

Do not ignore symptoms that may be due to low or high blood glucose. If you have symptoms that do not match the Guardian™ Sensor (3) reading or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter. If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.

Read this entire user guide before attempting to insert the sensor. The one-press serter (MMT-7512) does not work the same as other Medtronic insertion devices. Failure to follow directions or using a different serter may result in improper insertion, pain, or injury.

The sensor is designed to work with approved transmitters only. It prevents connection with transmitters and recorders that are not compatible with the sensor. Connecting your sensor to a transmitter or recorder that is not approved for use with the sensor may cause damage to the components. Refer to your system user guide for a list of compatible products.

Do not make therapy decisions based on sensor glucose values because sensor glucose and blood glucose (BG) values may differ. If your sensor glucose is low or high, or if you feel symptoms of low or high blood glucose, do the following prior to making therapy decisions. Confirm your blood glucose with your meter using a fingerstick blood sample.

Taking medications with acetaminophen or paracetamol, including, but not limited to Panadol™*, fever reducers, or cold medicine, while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen or paracetamol active in your body and may be different for each person. Always use BG meter readings to verify your glucose level before making therapy decisions, including when you could have acetaminophen or paracetamol active in your body. Always check the label of any medications to confirm whether acetaminophen or paracetamol is an active ingredient.

Do not expose your sensor to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields as the performance of the sensor has not been evaluated under those conditions and may be unsafe. If your sensor is inadvertently exposed to a strong magnetic field, discontinue use and contact your local representative for further assistance.