Register now to receive over 30 days of predictive alerts and continuous glucose monitoring straight to your smartphone.
Fill out the form below to join our CGM Evaluation program
You will receive 1x Guardian™ Connect transmitter, 1x box (5 each) of Guardian™ Sensor (3), 1x One-press Serter and associated training materials. You must also download the Guardian™ Connect app from the App store on your compatible iOS device.
Terms of the Evaluation
- Acknowledgement I am participating in the Evaluation voluntarily.
- This waiver serves as a notification that I am receiving product listed, hereinafter referred to as the “System”, at no charge
- 1x Guardian™ Connect transmitter, 1x box (5 each) of Guardian™ Sensor (3), 1x One-press Serter and associated training materials
- I will not provide the Medtronic System, in whole or in part, provided to me through the Evaluation to a patient, a healthcare professional or other individual, including, but not limited to those individuals living with diabetes.
- The System is intended for single-patient use. I will not allow it to be shared or otherwise repurposed by or with healthcare professionals or individuals, including but not limited to individuals living with diabetes.
- I understand that the System is loaned to me for the duration of the Evaluation only and agree to return the System and all unused product to Medtronic, upon completion of the Evaluation, and no later than thirty (30) days after the completion of the Evaluation period. I understand that I will be invoiced $599 for the System in the event that I do not return the System to Medtronic in accordance to foregoing.
- I understand that should I wish to continue using the Guardian™ Connect CGM system after the evaluation and sign-up as a Medtronic Guardian™ Connect CGM customer, I may keep the transmitter, serter, charger and test plug. However, I am responsible for purchasing sensors after the evaluation period ends. There is a 1-year warranty on the transmitter which will start on the day I receive product.
- I have not received any compensation to participate in this Evaluation and do not expect to receive any compensation from Medtronic or any other party for my participation in this Evaluation. My participation is solely for training and education for the System.
- I will be asked to complete a post evaluation survey on my experience with the System. I agree that the feedback captured in this survey may be used by Medtronic for marketing and education purposes, however any published information will not include my name or any information that could personally identify me.
- I hereby release Medtronic Canada ULC, its principals, directors, officers, agents, employees or affiliates from any and all liability of any nature for any and all injury or damage (including death) as a result of my use of the System and my participation in this Evaluation.
Risks
Potential risks and discomforts that may occur during this Evaluation are associated with potential reactions to the physical presence of the sensor, and could include skin irritation, bruising, redness, allergic reaction to the tape, bleeding at the insertion site and insertion site infection. If irritation of the insertion site is noted, the sensor should be removed.
GUARDIAN™ CONNECT CGM SYSTEM
- Do not use the Guardian™ Connect System for pediatric patients until you have thoroughly reviewed (with your Healthcare Professional), the system alert performance in the Guardian™ Connect Application User Guide and the sensor accuracy performance in the Guardian™ Sensor (3) Performance document. Discuss with your Healthcare Professional how to best set up your Guardian™ Connect System alerts to reduce the risk of missing low blood glucose or high blood glucose events.
- In the pediatric clinical study (3-18 years of age), larger differences were observed between the Guardian™ Connect System and actual blood glucose values compared to those differences observed in the adolescent/adult clinical study (14-75 years of age), particularly at low glucose levels.
- In the pediatric clinical study, a significant percentage of low glucose events were not detected by the Guardian™ Connect System. Do not rely solely on the Guardian™ Connect System alerts to detect low glucose.
- In the pediatric clinical study, the Guardian™ Connect System triggered a high percentage of false low glucose and false high glucose alerts. The Guardian™ Connect System is not intended to make therapy adjustments: always check your capillary blood glucose before making therapy adjustments.
- In the pediatric clinical study, enabling the ‘Alert Before Low’ and ‘Alert Before High’ predicted alerts significantly reduced the percentage of missed low blood glucose and missed high blood glucose events, but also significantly increased the percentage of false low glucose and false high glucose alerts. Do not ignore alerts from your Guardian™ Connect System. Always follow your treatment instructions from your Healthcare Professional when responding to an alert from your Guardian™ Connect System.
