We heard you: a message from Que Dallara

I wanted to personally reach out regarding the recent approval of our Simplera Sync™ sensor. While this should have been a moment of celebration, I understand many of you were disappointed by our communication. Over the past few days, I’ve had the privilege of speaking with many of you and listening to your concerns.

I know you’re eager to access our Simplera Sync™ sensor, but supply is limited. This means making tough decisions. Our teams are working to ramp up supply, but inventory will remain limited. Because of that, we'll have a waitlist and as a customer, you'll have the option to be included. This change means we will not be prioritizing new hardware customers.

We’re also refreshing our CGM portfolio by partnering with Abbott. We plan to launch this CGM in the U.S. first and today, we announced an important milestone towards making this a reality — we submitted for FDA clearance.

If you choose to wait for the Abbott CGM^†, you will be enrolled in our Innovations Program so that you can place your order first once we receive FDA clearance. You will then be able to software upgrade or purchase a new pump in order to use either Simplera Sync™ or the Abbott CGM. But, to make this possible, we have to wait to get FDA clearance and we need to increase our Simplera Sync™ supply, too.

Whichever option you choose, there’s no action needed now. What’s important is that the choice is yours. When we’re ready to start taking Simplera Sync™ orders in early fall, we’ll let you know details on how to choose. And when we can, we’ll provide a comparison of refreshed sensor options with more details so you can decide what’s best for you.

Please know we’re working tirelessly to deliver an updated CGM experience. We’re grateful for your patience — and your feedback. Thanks for the opportunity to do better.

Frequently asked questions
 

1. If I have a pump with Medtronic today, will I be able to get Simplera Sync™ when it launches?
   If you have a MiniMed™ 780G pump, you can join the waitlist for Simplera Sync™ though supplies are limited. If you are moved off of the waitlist, you will need to upgrade your existing pump's software.
    
2. What if I want to wait for the Abbott CGM^†?
   If you choose to do that, you’ll be first in line to place your order once we receive FDA clearance.
    
3. How long until you get FDA clearance so you can launch the Abbott CGM^†?
   We don't have a specific timeline to share, as the submission is with the FDA. 
    
4. Is the Abbott CGM^† the Libre sensor?
   It will be based on Abbott’s most advanced CGM platform.
    
5. Do I have to choose which one to get on?
   When orders open in the early fall, you can either join the waitlist for Simplera Sync™ or wait for the Abbott CGM†.
    
6. How do I get on the waitlist for Simplera Sync™ today?
   We haven’t opened the waitlist yet, but we’ll share more details and next steps as we get closer to taking orders this fall.
    

Footnote
† Investigational. Not cleared by the FDA for any use and not commercially available in the US.
 

Important safety information: MiniMed™ 780G system with SmartGuard™ technology with Simplera Sync™ sensor
 

The MiniMed™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at 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™ 780G System includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
 

The Simplera Sync™ sensor can be used one time and has a life up to 6 days, followed by a grace period of 24 hours. During the grace period, the sensor will continue to work as it did during the first 6 days, to allow the patient to change their sensor more flexibly. However, some sensors may not survive the full wear period for a variety of reasons. Please be prepared to replace the sensor during the grace period to ensure sensor glucose values continue to be monitored.
 

The Simplera Sync™ sensor is not intended to be used directly to make therapy adjustments while the MiniMed 780G is operating in manual mode. All therapy adjustments in Manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Simplera Sync™ sensor. The Simplera Sync™ sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Simplera Sync™ sensor in the abdomen or other body sites, including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.
 

The Medtronic MiniMed™ 780G System consists of the following devices: MiniMed™ 780G Insulin Pump, Simplera Sync™ sensor, the Accu-Chek™ Guide Link blood glucose meter, and the Accu-Chek™ Guide Test Strips. The system requires a prescription from a healthcare professional.

WARNING: Do not use the MiniMed™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 780G system.
 

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.
 

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. 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 https://www.medtronicdiabetes.com/important-safety-information#minimed-780g-simplera-sync and the appropriate user guide at https://www.medtronicdiabetes.com/download-library.