In March, we announced FDA approval of the world’s first Smart1 CGM, the Guardian Connect system. This all new continuous glucose monitor is specifically designed to provide valuable insights – right on your smartphone – so you can take action2 against highs and lows. If you inject insulin or manage diabetes with oral medication, I’m excited to announce that the Guardian Connect CGM system is available for purchase, for those who use an iOS device (Android available in the future).
Why Introduce a Smart CGM for People Using Insulin Injections? Because We Are Inspired by You!
The Guardian Connect Smart CGM was developed based on your feedback: This is why we’ve introduced the Guardian Connect Smart CGM. It’s also why we’ve partnered with IBM Watson Health (who are experts in using artificial intelligence to solve life’s everyday challenges) to develop the Sugar.IQ diabetes assistant. This first of its kind diabetes assistant is exclusively available with the Guardian Connect system and uses CGM information and smart algorithms to give you insights about what’s impacting your diabetes. Only with the Sugar.IQ assistant, you can see hidden patterns you’ve never noticed before, track your favorite foods to see how they affect your glucose levels3 and, just as important, you’ll receive encouragement to inspire you when things are going well. These insights empower you to manage your diabetes better than ever before and 89%4 of the people who tried the Sugar.IQ assistant liked the insights they received. We’re inspired by all people living with diabetes, wherever you are on your journey. Thousands of people worldwide have shared with us the importance of tools to help you understand your glucose and empower you to act on that information. We know people who prefer to manage diabetes with injections or pens deserve access to smart diabetes technology. Technology that provides valuable information and insights to help them make better diabetes management decisions.
A New Chapter for Medtronic
While we’re known for bringing together insulin pumps, glucose monitors and advanced algorithms to automate insulin delivery, we’re excited to enter a new chapter here at Medtronic. A chapter that provides multiple options for people living with diabetes. Depending on your needs, you and your healthcare team might decide the MiniMed 670G system, or the Guardian Connect CGM or even our i-Port Advance Injection Port is best for you. All of these options allow you to manage diabetes on your terms, which is most important. It also allows you to seamlessly switch therapies throughout your journey should you choose to do so. And, as the leader in innovation, we’re always working on what’s next to bring better technology to people living with diabetes.
What’s Next for Guardian Connect?
Even though we’ve just introduced the Guardian Connect CGM system, we’re already working on what’s next:
- Providing access for Android users is our first priority.
- We’re continuing to partner and innovate to bring even more smart tools to people with diabetes.
- We are launching a program to make it easy to transition from Guardian Connect to a MiniMed insulin pump system should you choose that path in the future.
What’s Next for Insulin Pump Systems?
We are listening to those who have chosen automated insulin delivery (i.e. the MiniMed 670G system) and want remote monitoring via smartphone as part of these systems. The Guardian Connect system is a key milestone to providing Bluetooth connectivity and smartphone access to customers using our insulin delivery systems. With Bluetooth-enabled CGM, we have one of the key components for the system, and we’re working hard to connect our insulin pumps and meters via Bluetooth as well. As we have an update we’ll let the community know. We’re also working on improvements to the system and expanding access for those interested in automated insulin delivery systems.
So, while we’re inspired by people like John and Nicky who use the MiniMed 670G system, we’re also inspired by people like Brett and Sara who choose to manage diabetes with pens and the Guardian Connect CGM system.
Our vision is to be a company for all people living with diabetes at all times throughout their journey. We’ve heard that you want to focus on your life, instead of your diabetes and we’re here to help you take one step at a time.
I personally am very honored to help you step-by-step in your journey.
1Smart CGM predicts future high and low sensor glucose events up to 60 minutes in advance and provides access to Sugar.IQ insights that can inform users of clinically relevant glucose patterns.
2The 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.
3The 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 glucose monitoring devices. All therapy adjustments should be obtained using a home blood glucose meter and not on values provided by the system.
4Medtronic data on file
5The 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. All therapy adjustments should be based on measurements obtained using a home blood glucose meter and not on values provided by the system.
698.5% low glucose detection rate based on Guardian™ Sensor 3 technology. With threshold and predictive alerts enabled within the 30 minute period before or after your blood sugar goes below 70 mg/dL.
7Users from outside of the U.S., using an earlier version of the Guardian™ Connect App. Low episode is defined as ≤70mg/dL in sensor glucose level; high episode as ≥180mg/dL in sensor glucose level.
Important Safety Information
The Guardian™ Connect 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 www.medtronicdiabetes.com/importantsafetyinformation.
The Sugar.IQ™ Diabetes Assistant
The Sugar.IQ™ app (MMT-8100) helps manage diabetes by facilitating the logging and display of meal entries and sensor glucose (SG) data, tracking meal log entries, reporting insights of how meals affect glucose levels, and supporting good choices and trends with motivational messages. The app serves as an additional display for real-time CGM data from the Guardian Connect system through the CareLink Personal™ software. It is not intended to provide medical advice and should not be relied upon for such purpose. The app is not intended to replace the real-time display of the CGM data on the Guardian Connect app, control any functions of the connecting device, calculate insulin or other drug doses, or modify data or control functions of the Guardian Connect system. All therapy decisions should be made by the app user based on blood glucose (BG) measurements obtained from a BG meter. Changes to treatment should only be made in consultation with a healthcare professional (HCP). For complete details, consult the user guide at http://www.medtronicdiabetes.com/download-library.
The 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, fourteen 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.
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
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