Medtronic Australasia Pty Ltd.
97 Waterloo Road North Ryde, NSW 2113
Phone: 1800 777 808

Overview of Guardian Connect

How does Guardian™ Connect work?

The Guardian Connect system measures glucose in the body and sends it to the Guardian Connect app approximatively every five minutes (about 288 readings a day). The transmitter communicates with the mobile app via Bluetooth connection. The mobile app utilises wireless connection to send data to CareLink Personal. Your care partners can also access your information from the CareLink website on most smartphones, tablets, or computers. These must be connected to the internet to receive information. Care partners can also elect to receive SMS messages for any applicable alerts.

Does Guardian Connect work with Insulin Pumps?

No. Insulin pumps operate on a radio frequency signal between the transmitter and the pump. This differs to the Guardian Connect system which operates on bluetooth low-energy (in order to pair with your iphone).

Do I need a prescription to obtain Guardian™ Connect?

Your healthcare professional will need to sign the order form for the Guardian Connect system.

Where can I buy Guardian™ Connect?

Guardian™ Connect will be available on the MiniMed eShop as a subscription. Please note - your healthcare professional will need to sign an order form before you can be granted access to purchase a subscription. A Medtronic representative will be in touch with you on how to purchase the subscription via the MiniMed eShop as an exclusive deal.

How long will it take me to get initially set up?

Depending on the person, it is estimated that it will take two hours to set up the Guardian Connect system. It is estimated to take approximately one hour to insert your sensor the first time, pair your transmitter, and set up the app. Once inserted, it will take up to approximately two hours for the sensor to warm up.

How many calibrations are required with the Guardian™ Connect?

Guardian Connect will require a calibration at least every 12 hours, and may prompt additional calibrations to improve sensor performance.

Is Guardian™ Connect available for children?

Yes, there is no age restriction to use Guardian Connect.

How does CGM differ from Flash Glucose Monitoring?

The Guardian Connect System is real-time Continuous Glucose Monitoring with sensor glucose readings provided every five minutes. Flash does not provide a continuous transmition or display of data, but relies on patients scanning the sensor. CGM is prescribed to patients who are hypo prone, hypo unaware, poorly controlled, or with significant glucose variability. The key benefits of CGM for these patients are ensuring excursions are detected by the system and that the patient can be alerted in real time, especially for hypos, to reduce excursions. Flash doesnt monitor glucose values continuously, cannot pick-up any excusrsions in real time nor inform the patient. The patient has to scan to see the data, and may notice most of the excursions after they have already happened , without being able to act on them. With Guardian Connect, you have reassurance of knowing that you will get automatic alerts of highs and lows so you can act promptly.

Who do I need to see for training?

You should consult with your healthcare provider to ensure you receive the correct product training. You can also review the Guardian Connect training modules located on the Medtronic website: Guardian Connect

SENSOR & TRANSMITTER

What is a glucose sensor?

A glucose sensor is a tiny electrode that measures your glucose levels. It sits under the skin in your interstitial fluid. Glucose sensors are easily inserted using an automatic insertion device: a needle is used to insert the glucose sensor. The needle is then removed leaving just the tiny flexible electrode under the skin. The glucose sensor is then connected to a transmitter so that readings can be transmitted to your compatible iOS device for downloading to software.

Do I still need to do fingerstick readings if I use glucose sensors?

Using glucose sensors does not replace the need for fingerstick measurements. You still need to use your blood glucose meter to confirm a Continuous Glucose Monitoring (CGM) reading before treating or to calibrate the CGM system.

What are the highest and lowest glucose alarm thresholds that I can set?

High alarm thresholds can be set as high as 22.2 mmol/L and the minimum low alarm threshold can be set as low as 2.2 mmol/L. High and low threshold ranges can be customised and you should discuss your personal threshold levels and alert settings with your healthcare professional. The high and low glucose alarms have to be at least .6 mmol/L apart. Remember, if you set your high glucose limit at 10 mmol/L, then you cannot set your low glucose limit greater than 9.4 mmol/L. Conversely, if you set your low glucose limit at 2.8 mmol/L then you cannot set your high limit lower than 3.4 mmol/L

How long do glucose sensors last? Do they expire?

Each glucose sensor can be worn for up to 6 days at a time. Glucose sensors have a 6­month expiration date from the time they are manufactured. The expiration date is on the outside of the glucose sensor box and on each individual glucose sensor package.

What type of batteries does the transmitter use?

The transmitter has a self­contained battery, which can be recharged using the charger supplied, but cannot be changed. As it has a self­contained battery, the transmitter should be disposed of, or recycled, in accordance with local governing ordinances and recycling guidelines.

What is the warranty of the transmitter?

The transmitter comes with a 12 month warranty.

Do I need to refrigerate my glucose sensors?

The Enlite™ glucose sensor can be stored at temperatures ranging between 2˚ and 30˚Celsius without the need for cooling. Glucose sensors must not be frozen.

Where should I wear a glucose sensor?

This can depend on what you’re wearing, your desired comfort level, individual preference or experience. While many people choose the abdominal area, some people prefer the upper buttocks, as this location is less likely to be bumped or affected by clothing at the waistline. See the Enlite User guide for recommended locations of insertion.

How often do I need to charge the transmitter?

You should charge your transmitter before inserting your sensor. A fully charged Guardian Connect transmitter will last at least six days without recharging. You should also charge your transmitter until the green light displays (could take up to two hours).

How do I pair my transmitter with my iOS device?

You can easily pair your transmitter with your iOS device if your Bluetooth is turned on. In the Sensor Set up page of the Guardian Connect app, you can click ‘Pair Transmitter.’ The app will search for nearby transmitter and display the applicable device. You can select the device to pair, click on the device number, and pair within just a few moments.

How does the transmitter send data to my mobile device?

The transmitter sends data to the mobile device via your phone’s Bluetooth connection. The Guardian™ Connect system requires Bluetooth 4.0 and above. You can still use your headsets and other Bluetooth connected while using Guardian™ Connect.

What is the distance the transmitter can be from the app to transmit data?

The transmitter must be within 6 meters of the mobile device (similar to range between Bluetooth headset and phone) to properly transmit data.

If my transmitter is out of range of my iOS device, what happens to the data?

If the transmitter is out of range from the iOS device, your transmitter will continue to calculate and record sensor glucose until next required calibration. The sensor glucose values will display on your app when you reconnect.

Is the transmitter waterproof?

It is waterproof up to 2.5 meters for up to 30 minutes.

How will I know if my transmitter battery is running low?

If your transmitter battery is running low, you will get an alert on your mobile app when you have one day of battery life. You can also refer to the System Status menu of the Guardian Connect app to see how much battery life is left. Always charge your transmitter before inserting your sensor to ensure your transmitter has enough battery life to last for six days.

What happens if you get a calibration prompt and it’s not an ideal time to calibrate (ie child at school)?

If you receive a calibration prompt, you will either need to take the calibration OR the app will stop taking readings until the next calibration is entered.

Are calibration Blood Glucoses represented in the graph different to other Blood Glucose entries?

They will look the same on the graph, but if you tap the icon, you will be able to see whether it was a calibration or just a Blood Glucose check.

What is the maximum range that the transmitter/sensor needs to be to the phone?

The Bluetooth connectivity between the transmitter and mobile device is up to 6 meters. If out of range,

Why might I need to calibrate more than two times per day?

The Guardian Connect system monitors your sensor readings throughout the day to ensure your sensor glucose readings remain accurate.  The system may sometimes request that you do an extra calibration if it detects that the accuracy of your sensor could be improved.

The time to next calibration displayed in the app will typically reflect any changes in calibration timing.  In some cases, the system may bring forward the next calibration, to happen at 6 hours instead of 12 hours. In other cases, the system may detect a need to calibrate immediately to maintain accuracy, and you will receive a “Calibrate Now” alert without seeing any prior change in time to next calibration.

If you do not calibrate when prompted, the Guardian Connect app will stop displaying your sensor readings until you have entered a valid calibration.

What happens if you get a calibration prompt and it’s not an ideal time to calibrate (i.e. child at school)?

If you receive a calibration prompt, you will need to take the calibration or the app will stop taking readings until the next calibration is entered. A way to avoid any inconvenient timing is to plan the day and calibrations according to your schedule.

Are calibration blood glucoses represented in the graph different to other blood glucose entries?

They will look the same on the graph, but if the user taps the icon, they will be able to see whether it was a calibration or just a blood glucose check.

GUARDIAN™ CONNECT APP

How can I download the Guardian™ Connect app?

You can download the Guardian Connect app here. You can download it for no cost.

What mobile phones and OS is it compatible with?

The Guardian Connect app is compatible with iOS9 and above. The app will be compatible with the following hardware devices: iPhone 4S iPhone 5 iPhone 5C iPhone 5S iPhone 6 iPhone 6 Plus iPhone 6S iPhone 6S Plus iPhone SE iPod Touch (5th generation) iPod Touch (6th generation) iPad 3 iPad 4 iPad Air iPad Air 2 iPad Pro iPad Mini iPad Mini 2 iPad Mini 3 iPad Mini 4

Why is this only available for iPhone?

We are working to add Android functionality in the near future; however at this time the app is only compatible with iOS devices.

What data is sent from the transmitter to the app?

Every five minutes while your transmitter and mobile device are in the operating range (up to 6 meters), the transmitter will send the most recent sensor glucose reading from your sensor. If you travel out of range, the data will backfill once you are back in range as long as the calibration is not timed out.

What data does the app send to CareLink®?

Approximately every five minutes while your transmitter and mobile device are in range (6 meters) and while you are in Wi­Fi or cellular range, the mobile app will send the most recent sensor glucose reading from your sensor and any un­cleared alarm. Every 24 hours, your mobile device will send full details from your phone, including sensor glucose readings and graphs, alerts, and event markers. You can choose to deactivate such option within your app by turning off the ‘Sync to CareLink’ setting.

How much data is stored or used?

Storage required to install the Guardian Connect app on your iOs device is around 17MB.Then the app sends data to CareLink via your mobile device’s cellular data or Wifi connection. It uses the equivalent amount of data as does downloading 10 MP3s per month (or about 1MB per day).

Can I view my Guardian™ Connect data on Apple Watch?

At this time, you cannot view your Guardian™ Connect data on your Apple Watch.

What do I do if I am not hearing any alerts on my device?

When the Guardian Connect app is not open, or your device is locked, the style and appearance of alerts depends on the notification settings on your mobile device. Do not turn off notifications or enable the Do Not Disturb setting on your mobile device. Doing so may result in missing important alerts requiring your immediate attention. Do not force the Guardian Connect app to quit. Doing so will stop transmission of sensor glucose data, and you will not receive any alerts. If the app is running in the background on your mobile device, you will still receive sensor glucose data and may still receive alerts depending on your mobile device's notification settings.

What if I am traveling and my data plan does not cover, will I still be able to transmit data?

As long as Bluetooth is on, your app will still be able to show data. You should refer to your carrier for more information on cellular data while traveling with your iOS device. If you are worried about data charges, you can disable CareLink uploads while you are traveling.

If I am out of cellular or Wi­Fi range, what happens with the alerts?

You will still receive your alerts on your phone. If you have cleared your alerts before coming back in range, your care partner will not be alerted via SMS message. If the alert is still displayed on your screen when you come back in range, your care partner will be notified via SMS message. While your care partner will not be able to see the data or receive SMS messages while you are out of range, the app will store the data and upload to CareLink when you are back in range.

If you put your phone in low power mode – does Guardian Connect still work?

Yes it will still work as long as the device is up and running.

Can the user silence/snooze the ‘calibration alarms’ that are set?

No, calibration alarms cannot be snoozed. Low and high alerts can be snoozed for up to three hours.

Why won’t this system connect my pump to my phone?

Guardian Connect is a standalone continuous glucose monitoring system designed for people using multiple daily injections. Guardian Connect will not communicate with insulin pumps. It is recommended that you consider a sensor augmented pump if you are interested in CGM.

If you put your phone in low power mode – does Guardian Connect still work?

Yes, it will still work as long as the device is on and still and operating correctly.

CARELINK® PERSONAL

Do I need to have a CareLink® account?

To use Guardian Connect, you do need a CareLink account. You do not necessarily have to send your information to CareLink and/or to enroll any care partners, but you do need to have a CareLink account in order to use Guardian Connect. You will be prompted to sign up for a free CareLink account when your first set up Guardian Connect

How many people may I share my data with?

You can share your data with up to five people.

Do my care partners need to have an Apple device?

No, care partners do not need to have Apple devices in order to access Guardian Connect data. Care partners can access the CareLink Connect tab data from any internet­connected device (any phone, computer, or tablet with internet connectivity).

Will my care partners get an SMS message for every alert or alarm?

When care partners set up their CareLink accounts, they have the ability to specify for which alerts they wish to receive SMS messages. Care partners can also choose to set a delay period between when the alert is triggered in the app and when they receive the SMS message. This delay period was designed to allow the person with diabetes to take action to bring their sensor glucose levels within range before the care partner is notified.

How quickly are SMS messages sent to your care partner?

If the transmitter and iOS device are within range and you are in cellular or wireless network, the SMS should be sent within one minute from the time that the alert has triggered from within the app (unless you care partner has set a delay).

Who pays for the SMS sent to care partners?

Medtronic pays for the service of the SMS message to be sent from CareLink to the care partner. Please refer to carrier for information on charges for received SMS messages.

Can a care partner follow more than one person with Guardian™ Connect?

Yes, care partners can follow more than one person using Guardian Connect. Care partners will need to have unique logins for each CareLink account in order to follow more than one person. Care partners can also receive SMS messages for more than one person using Guardian Connect. The name of each person will be prominently displayed in the relevant SMS messages.

How do I remove someone from seeing my data?

Within your CareLink Connect tab, you will be able to remove care partner from seeing your data.

How will CareLink® Personal help my healthcare professional?

If you have the ‘Sync to CareLink’ setting turned on, you will no longer have to manually upload your data to CareLink. This means that you’ll save time during your office visits because you will not need to download your data while in the office. Furthermore, having more details about your diabetes will allow you to have productive conversations with your healthcare professional about your treatment options.

I am a parent to multiple children with diabetes; can I see all of their information in one place?

At this time, you cannot see all information in one place. You’ll need to have separate credentials to login to each of your children’s CareLink accounts.