FDA approves the Guardian™ Connect system, the world’s first “smart cgm” to help people outsmart their diabetes
I’m thrilled to share some great news – we just received FDA approval for a new category of smart, standalone CGM, the Guardian™ Connect system! What’s more, people using this system have exclusive access to the groundbreaking Sugar.IQ™ smart diabetes assistant.
Louis Dias recently wrote about our culture of listening at Medtronic. As we’ve listened to you, one of the things you’ve taught us is that every person’s journey with diabetes is unique and that you need different types of technologies to support you at different times during this journey. That’s why we created the Guardian™ Connect system.
As proud as we are of our world-leading automated insulin delivery systems, we know plenty of people living with diabetes prefer multiple daily injections (MDI) to insulin pump therapy. But, for those of you on MDI we’ve also heard that you want valuable information to help you make better, more informed decisions about your diabetes so you can focus on your life. To do that, we created not just another continuous glucose monitor (CGM), but a smart standalone CGM.
So how is Guardian™ Connect a Smart CGM?
Smart monitoring with the power to predict
The Guardian™ Connect system continuously measures your glucose levels and delivers them right to your smartphone every 5 minutes. More importantly, it’s the only standalone CGM system that uses smart technology to predict where your glucose levels are headed. It alerts you from 10-60 minutes in advance that you’re predicted to hit a low or high glucose threshold that you’ve previously set. This means you only receive alerts when you actually need them and allows you to take action before a low or high is likely to happen. It’s all about being proactive vs. reactive and outsmarting your highs and lows so that you can focus on living your life, not watching your glucose levels.
Smart insights to keep you on track*
Guardian™ Connect is the only CGM that comes with access to the Sugar.IQ™ smart diabetes assistant. Using the same supercomputer technology that can predict global weather patterns, Sugar.IQ™ analyzes your glucose, insulin, food and other data to offer you tips and insights that help you make more confident, data-backed decisions. This one-of-a-kind technology, supercharges your understanding of daily glucose patterns and the factors affecting them. Have certain foods that cause havoc on your diabetes? Are there certain days or times of the week where your glucose goes high or low? Sugar.IQ™ helps you uncover these hidden patterns so that you can confidently make small adjustments that will have a big impact on your day.
Smart Glucose Sensor
The Guardian™ Connect system includes the Guardian™ Sensor 3, our most advanced glucose sensor and the best sensor on the market at detecting lows. We know how worrisome lows can be and this sensor has a 96% low detection rate**, so you can worry less and do more of what you love.
How does it work?
The system consists of a small sensor you insert in your abdomen and can be worn for up to 7 days. It measures glucose levels from fluid under the skin and attaches to a slim, discreet Bluetooth® transmitter that sends readings to an app on your smartphone (initially only available for iOS users). Within the user-friendly app, you can see your glucose readings continuously and set up customizable alerts and alarms. If you like, you can also keep your loved ones connected to your care with automatic text alerts and access to our CareLink™ system.
Availability
The Guardian™ Connect system and the Sugar.IQ™ smart diabetes assistant will begin shipping in the U.S. this summer. If you’d like to be first in line to receive Guardian Connect or speak with a representative, you can add your name here. The product will initially only be compatible with iOS smartphones, iPod and iPad. We’re working on Android compatibility, and will keep our community updated.
IMPORTANT SAFETY INFORMATION:
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 assistant 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.
**Values at 70 mg/dL. Guardian Sensor 3 data from Summary of Safety and Efficacy Data. Dexcom G5 data from product User Guide. With threshold and predictive alerts (for Guardian Connect system).
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Medtronic DiabetesMedtronic Diabetes is dedicated to helping people get more out of life by creating innovative technologies and providing extraordinary support so you can manage diabetes on your own terms.
Blog comments
Frank, the Guardian Connect system is intended for people who wish to use MDI or pens as their therapy of choice. We do understand that connectivity with our insulin pump systems is important and the release of the Guardian Connect system is proof that we've made the first big step with Bluetooth capabilities in our transmitter. We're not working on the rest of the system and making sure everything works together seamlessly.
Hallo, when will "Medtronic Guardian Connect" for Android be released?
Chris, we understand the need to support Android smartphones, and are working on an Android version for Guardian Connect. Unfortunately, at this time we don’t have a timeline to share. We will make sure to keep our community updated.
Will the device be covered for our Medicare patients?
Laura, after reviewing the Centers for Medicare and Medicaid Services (CMS) decision on CGM coverage as well as how it applies to the Guardian Sensor 3, Medtronic is pursuing new, non-adjunctive labeling. We believe this will enable reimbursement for Medicare patients who use Medtronic CGM. However, at this time we do not have a timeline to share of when this might happen.
any update on codes or labels for medicare coverage?
Great question, Heather. Currently, there are no new updates on Medicare reimbursement for our sensors, but please know we are committed to seeing this process through. In the meantime, we do offer payment plans and financial assistance options. If you'd like to learn, please give us a call at 800.646.4633 option #4.
What a disappointment it is not working with the 670G. I may not be long for Medtronic ones other closed loop systems are available
I just starting using the 670G monitor and I really don’t like it. It is too heavy, big and bulky. I have decided to go back to my old monitor (uses Enlite sensors).
I am surprised that Minimed hasn’t received complaints about this. I feel like it is a step back...try putting it under your shirt at your waist...it bulges out. Forget about wearing a dress. It is very uncomforatable.
The system many be advanced but the monitor is terrible!
I'm sorry you feel this way, Deborah. The main reason for the increase in size over our previous Paradigm series pumps is to accommodate the AA battery which is required to properly power the pump and color screen.
The overall increase from the Paradigm 3.0 mL size of pumps is only a 17% volume difference.
Has it been approved for Medicare yet? I’m anxiously waiting. Tired of going low ast the drop of a hat. It would be nice to have some warning
Not yet, Rosemary. We are working closely with the FDA to receive updated labeling to continue pursuing Medicare coverage. I don't have a timeline to share, but we'll be sure to let our community know.
I really hope that Medtronic is moving quickly to get this moving on the 670g. We have seriously considered moving to a different system given how difficult monitoring is for our 8-year old. Currently with the 670g we have to have multiple phone calls and texts to manage her numbers throughout the day. Due to this both my husband and I have had to change jobs and have endured significant negative experiences. We did not experience this when we could remote monitor. It is very, very frustrating and really not an improvement over MDI. In fact, her A1C was better when we were doing MDI with high monitoring remotely, than it has been on this particular pump.
For my daughter that recently had a couple of scary lows and she is caring for her baby. Thankfully, last time, her infant son cried enough to get his father to check on them. My daughter wasn't responsive. This sounds like a terrific way to prevent such an event and I hope we can get it into action soon.
Did your daughter's Endocrinologist reduce her insulin dosage(s), basal and or insulin carbohydrate ratio after the birth of your grandchild?
It so frustrating to be left behind the competition when using the 670G and wanting to see numbers on your phone or watch. The closed loop of the 670G is awesome, but having to pull my pump out to see my blood sugar numbers just adds wear and tear on the tubing. I would like to see results and not just 'we are working on it'.
I agree with Jason H above. Making the entire pump Bluetooth will open it up to security risks. When my doctor told me the blue tooth CGM was approved I thought it would be a mixed mode where only data would be exchanged over Bluetooth and the rest of the communications would remain as it is.
Looks like a hack system of using some kind of small/tiny computer to use the current tester that talks to the pump to get data on your phone is going to be needed.
I feel the company cares about the closed loop technology but not the user experience/usability of the 670G.
I’m sorry you’re frustrated, Tim. We certainly care about our customer’s experiences and are always looking on ways to improve them. We know that having connectivity is an important feature and we look forward to having this option available with our pump systems. Unfortunately, we don’t have a time frame on when this will be available or what features would be included. We're making sure we take the time to develop this feature correctly to create the best customer experience and to ensure patient safety. We will make sure to update our community as soon as we we’re able.
Was wondering if anyone else is having trouble with the duration of the guardian sensor. My son's sensor generally only last 4-5 days. We live in Florida and just recently found out the sensor is not waterproof for more than 30 min. (that is essentially a daily 5 min shower.). Because Medttonics states they last up to 7 days, most insurance allow 5 sensors per month so they have to last 6days or you will run out. Getting insurance to agree to more is difficult as Medtronics thinks they last a week????
This sensor is big and bulky. Requires a gap in monitoring between changes as the battery has to be charged. Also the insertion is awkward. Very disappointed we changed to Medtronics. .
I'm sorry to hear this, Marlene. This is certainly not the experience we have come to expect based on feedback from our customers using the MiniMed 670G system. I would like to connect you with a senior teammate, who may be able to help. Please send your son's name and a phone number you can be reached at and we'll get you connected with a teammate.
So the comment policy link doesn’t work! Just like most of the garbage you are trying to relate on this blog.
I'm sorry you're having trouble. I took a look and our policies link is working as expected. If you have questions or need help with anything, please email us at dhelp@medtronic.com.
Oh so it works for you (Medtronics) but not for anyone else (users, Medtronics customers) so you consider it to be fine and insist that it is my trouble. Sounds typical of Medtronics’ approach to customer satisfaction.
Not at all, Heath. We're here to help in any way we can. If you'd like to discuss this in more detail, please send us an email and we'll see what we can do to help.
What pump/cgm combination do you recommend for someone on Medicare?
Hi, Mark. Our MiniMed 630G pump is approved for use by our customers on Medicare. Currently, Our CGM products are not covered by Medicare guidelines, but we are with the FDA for updated labeling. If you'd like to learn more or discuss your options, please give our therapy specialists a call at 800.646.4633, option 3.
I start on Medicare next month and am sooooo disappointed. My out of pocket expense to continue using the 670G and Monitor will be over $1000/mth. I cannot afford this and do not qualify for Medtronics assist program. WHEN will medicare cover the CGM? Any updates? I'm considering just paying for a different system?
Hi, Susan, thanks for your comment. I don’t have a timeline on when Medicare will provide CGM coverage, but we are actively working with the Centers for Medicare and Medicaid services to establish coverage consistent with other healthcare insurance companies. We suggest that you talk with your health care team, so they can advocate for CGM coverage on your behalf.
If you call Medtronic they have no info and will not know anything until all of. Sudden the FDA lets them know then Voila. This should have taken place long ago. I do not believe the 670G sensors will ever be covered by Medicare. Terrible. We are doing appeals to Medicare and BC/BS. I know some people have won these appeals.
I'm sorry you're disappointed, Sally. We know how important these technologies are and work extremely hard to ensure access to as many of our customers as we can. Please know, our teams are unable to share updates until our products and services have been approved by the FDA. We are committed to working with our customers, the Centers for Medicare and Medicaid Services and the FDA and securing coverage. We appreciate your feedback and hope you'll stay tuned for updates.
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