GUARDIAN™ SENSOR 3 Continuous Glucose Monitoring System

Manage glucose levels with a smart continuous glucose monitoring (CGM) system, powered by Guardian™ Sensor 3.

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Overview

BENEFITS OF CGM

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Real-time glucose readings to compatible devices

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Early notification of oncoming lows and highs throughout the day and night

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Visibility to the direction your patients' glucose levels are going

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Visibility of time spent high, low, and within a glucose range of 70–180 mg/dL

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Insights into how food, physical activity, medication, and illness impacts your patients' diabetes1

GUARDIANTM SENSOR 3 POWERS OUR PUMP AND CGM SYSTEMS

Smartguard™ Pump Technology

Integrated with our latest advancement in insulin pump therapy, the Guardian™ sensor 3 enables different levels of automation that fit your lifestyle:

Sugar.IQ™ Smart Assistant with IBM Watson™ CGM Technology

Only Guardian™ Connect CGM powered by Guardian™ Sensor 3 works with the Sugar.IQ™ personal diabetes assistant (available for iOS/Apple devices only), which supercharges your understanding of daily glucose patterns and the factors affecting them1 for a fuller picture of your patients’ diabetes.

Guardian Sensor 3 sitting next to a smartphone displaying a screen from the Sugar.IQ App.

GUARDIANTM SENSOR 3

The Guardian Sensor 3 powers the Guardian Connect system with the Sugar.IQ app.
  • Our most accurate sensor with a MARD of 8.7%.
  • Easy insertion with one-press serter and flexible design make it comfortable to wear every day.
  • Continuously measures your patients glucose levels.

Ages 7 to 13

Conditions Abdomen MARD Buttocks MARD
3-4 calibrations/day 9.84% 8.79%
2 calibrations/day 10.46% 9.14%

Ages 14 and Up

Conditions Abdomen MARD Arm MARD
3-4 calibrations/day 9.6% 8.7%
2 calibrations/day 10.6% 9.1%

WEBINARS    

On-demand videos offer practical tips from clinical experts for using Medtronic Diabetes therapies to help you support patients.

 

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USER GUIDES AND MANUALS

Browse our library to find reference materials for your Medtronic Diabetes products.

 

VISIT LIBRARY
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Refers to Auto Mode. Some user interaction required. Individual results may vary.

MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values.

Arm sensor insertion site, 3-4 calibrations/day. Approved for ages 14-75 years.
1

The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices. All therapy adjustments should be based on measurements obtained from standard blood glucose monitoring devices and not on values provided by the system.

Important Safety Information: Guardian™ Connect CGM System
The Guardian™ Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The system requires a functioning mobile electronic device with correct settings. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at http://www.medtronicdiabetes.com/support/download-library/user-guides and http://www.medtronicdiabetes.com/importantsafetyinformation.

For proper instructions on inserting the Guardian™ Sensor 3, visit the support webpage for inserting your sensor.

Important Safety Information: MiniMed™ 670G System
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, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 670G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitor sensor glucose values, and can suspend 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 Guardian™ Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. 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. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode.

WARNING: Medtronic performed an evaluation of the MiniMed™ 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and 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™ 670G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library.

Important Safety Information: MiniMed™ 630G System with SmartGuard™ Technology
Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. The MiniMed™ 630G or MiniMed™ 530G system are not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The SmartGuard™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia. Before using the SmartGuard feature, it is important to read the SmartGuard™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.

See www.medtronicdiabetes.com/importantsafetyinformation and the appropriate user guides for additional important.

Important Safety Information: CareLink™ Personal Therapy Management Software
The CareLink™ software is intended for use as a tool to help manage diabetes. The purpose of the software is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink™ reports. The reports provide information that can be used to identify trends and track daily activities-such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. There are two versions of Medtronic MiniMed™ CareLink™ Therapy Management Software available - CareLink™ Personal and CareLink™ Pro.

Contraindications
The CareLink™ software should not be used for the treatment of medical conditions other than diabetes.

Warnings/Precautions
The software is intended to be used by or with advice from a healthcare professional familiar with the management of diabetes.
System results are not intended to produce medical advice and should not be relied upon for such purpose.
Patients should monitor their blood glucose levels at least 4 - 6 times a day.
Patients should not make any changes to their treatment without consulting their healthcare professional first.
See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/carelink

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