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Alert: Product and Recall NoticesFDA 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.
Learn More
Want to learn more about Guardian™ Connect and Sugar.IQ™ from the people who helped develop it? Join us tomorrow at 4pm PST/7pm EST for a special Facebook Live! We’ll be taking questions live and would love to hear from you!
In the meantime, you can also find more information about Guardian™ Connect here and Sugar.IQ here.
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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About Author
Editorial Team
LOOP Blog Editorial TeamAt Medtronic Diabetes our vision is to transform diabetes care together for greater freedom and better health. Each word in that statement is important – including the one “together”. We’re a group of passionate people working hard to make a big positive impact on the lives of those with diabetes. But we can’t do it alone. Collaboration is key. With healthcare providers, academic institutions, non-profits and other companies. And, most importantly, with you – the people who live with diabetes every day.
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.
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.
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.
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.
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.
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?
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.
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 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.
What a disappointment it is not working with the 670G. I may not be long for Medtronic ones other closed loop systems are available
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.
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.
With Apple getting ready to release its 4th gen. watch , using laser in the band to read bg levels with no sensor and given the fact that a 5 pack of Guardian 3 sensors run around $ 600 retail … why would someone get the Medtronics stand alone CGM system that is not integrated with pump for ease of us ? Given that the Medtronics system still recommends that one use a SEPARATE BG test (finger stick) to bolus / test. Technology and high cost of sensors makes a $ 600 watch and band set up very cheap when you consider that one is locked into a monthly purchase of sensors from Medtronics 🙁 Medtronics has had years to consider these features and integrate such into its pumps. My gut instinct tells me it just wants to phase these in for future $profits$ ……
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.
Hopefully software development for use with the 670G will integrate the readings to a smartwatch and or blue tooth to your vehicle for audio alerts. The safety increase would be obvious especially while driving a vehicle. Hate receiving alerts on the pump while strapped in a seat-belt not being able to know what conditions are causing the warnings, low, high BG’s or low battery, etc.. without having to pull over. Some might struggle to un-clip the pump to see it. This would definitely increase the likelihood of an accident.
Can someone tell me if the Medtronic 630 CGM uses the same sensors and number as the 670 G insulin pump? Is there a page where I can compare the two? Thanks.
Bea, our MiniMed 630G system uses our Enlite sensor, while our MiniMed 670G system uses the Guardian Sensor 3 sensors. You can check out our website at http://www.medtronicdiabetes.com to learn more about our family of products and submit your information to be connected with a teammate. As far as which pump is best for your daughter, that’s going to be based on her needs and the recommendation of her healthcare provider.
Hello – just so I understand the new product coming out is not compatible with the 670g pump and CGM sensor already available? This new product is a different type of sensor for the non pumpers that are using vials and syringes? Is this correct?
Pam, the Guardian Sensor 3 is used to power both our MiniMed 670G CGM and the Guardian Connect, however, the transmitter for each CGM is different. You are correct that the Guardian Connect is designed for those on MDI and not insulin pump therapy.
Is it anticipated that this new product will be covered by Medicare?
At this time, Denis, Medicare does not cover our CGM, but we are working with the Centers for Medicare and Medicaid Services to establish coverage consistent with other national plans.
Hi Karrie,
Please update on Medicare coverage of the Guardian Sensors and test strips as of December 27, 2018?
If Medicare does not cover them advantage plans will not.
What can you tell us?
Thanks for reaching out, Sally. At this time we are still working with Medicare and the FDA for updated labeling, which we hope to use as a path to secure Medicare coverage. Unfortunately, I do not have a timeline to share. We’ll be sure to keep our community updated with news as it becomes available.
For a person considering a new pump and wanting to use a cgm, what is your current recommendation?
I hope the price will be reduced. My flyer stated a very steep price for it.
Michelle, we certainly understand. The individual out of pocket expense will vary based on your insurance coverage. We’ll have more specifics once the Guardian Connect is available.
Will my insurance cover this
Hi Jason, we have a team of people here who can help check with your insurer to see if Guardian Connect system is covered. We work with many providers nationwide and can often help with the process and paperwork. If you’d like to get updates on the Guardian Connect system including coverage information, please complete the form here: http://bit.ly/2FLEGeo.
When you talk about stand alone CGM. Does this mean it will work without being integrated in one of the Medtronic pumps ? What is have a back up receiver if the phone is not working?
That is correct, Mark. This is a standalone CGM that does not integrate with an insulin pump. If for any reason your phone is not working, you would not have access to your Guardian Connect app, as there is not a separate receiver.
The current supply of Guardian sensors cannot meet the current demand. I’m not sure why Medtronic is adding more customers to the mix when current customers has supplies on back order. What is the pan for this?
Sarah, we’ll always prioritize our current customers and make sure that they have sensors available before we add anyone new to our systems. We’ll begin shipping the Guardian Connect system later this summer to make sure that we have enough supply to take care of current customers and future customers.
This doesn’t seem like new news. What am I missing? I thought the FDA approval came early in 2017, and the 670G starting going to certain people later summer.
Paul, the Guardian Connect system is for those who are not on insulin pump therapy and manage their diabetes with multiple daily injections. It’s a Smart standalone CGM system that helps people by giving predictive alerts and insights from the Sugar.IQ diabetes assistant. However, it is not integrated with our insulin pump system.
Thank you for the clarification. So, the Guardian Connect is the stand alone CGM. And, the Guardian Sensor is the one that works with the insulin pump?
The Guardian Sensor 3 is the approved sensor for use with both the CGM for the MiniMed 670G system and the standalone Guardian Connect. The transmitters for each CGM are different.
I presume this, like every other product pronised by medtronic to European customers will a) take years to appear and b) never be properly supported on Android?
Make the SDK open source and allow those who know how to write code do so – you make great medical products but you’re years behind – even carelink is 10yrs behind the curve and isnt supported on most current browsers now – forcing users to maintain unsecure browsers or stop using the site completely. This historical data and the fantastic reporting it provides is critical to long term sucessful management of my diabetes but its getting harder to access the site.
I presume that, like any other critical post i have made in the past, this will not be posted, but am happy to also discuss offline.
I have a CGM machine for.my Diabetes it work well with my insulin l hate we can .use it with my phone
But it’s only available for the 670g so there’s that. Hope the Medtronic team is successful in its attempts to get the Guradian approved for the 630g and allows the 630g users to use the app as well.
Will these transmitters be sent out free of charge like the 67G if you had the 630G? Can we swap them?
Chance, our Guardian Connect is intended for use by customers still taking MDI and adding the benefit of CGM to their diabetes management. This CGM is not integrated with your insulin pump system.
Will the smartphone data link be available for current 670G pump users? This is such a valuable tool for easy access to SG data both for users and loved ones. Miss the 530G pump only for that reason. Thanks,
Not at this time, Ken. Although the Guardian Connect system and the MiniMed 670G system both use Guardian Sensor 3, the transmitter is not the same. We’re committed to offering a family of products so each individual living with diabetes has the best technology to meet their personal needs and we’re continuing to work on providing new solutions.
We know you are not going to shares time lines or any relevant details about adapting this technology for the 670g population but is Medtronic, preparing the necessary infrastructure and support to facilitate what ever roll out to accommodate all the 67gg users? The minimed pathway program was a nightmare!! Do not squander this time, get your ducks in a row now!
Yes, we are, Dan!
For my daughter Kristen Johnston
Sounds great but when will we be able to monitor SG using a smartphone when we use the 670g in automode? It is a pain connecting and disconnecting the pump countless numbers of times a day just to see the screen with the SG readings. Thx.
Fred, this is an important feature we are working to develop, but we unfortunately are not able to share timelines.
So what is the charge for this and how far out do you expect Android devices to be added?
Doris, more details on the price and avaibilitiy will be provided later this summer. 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.
Can you please tell me if there is an app out yet for Android users?
Thanks
Thanks for checking in, Lisa. 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.
Can I add the app to my phone if i already have the 670g?
Spencer, the Guardian Connect app communicates with a different transmitter than the one provided with the MiniMed 670G system. We understand the value of connected care and are working hard to make apps like the one used with Guardian Connect, available to our customers using our insulin pump systems.
This is such great news!! We want to know what our sons BS numbers are after school or at practice, but don’t want to keep texting him about it, since he gets frustrated with us:) The the Guardian Connect would be a wonderful addition to helping us know his numbers. Please tell me this works with the Medtronic 670? We already have the Guardian Sensor 3 that works with our 670, will we have to get a new sensor?
Robin, at this time, our MiniMed 670G customers will not have access to the Guardian Connect app. It communicates with a different transmitter than the one provided with the MiniMed 670G system, but we are working to make this technology available for our pump systems.
I love my 670G, but am really surprised (and disappointed) Medtronic has not put connectivity for those of us already using their pumps at the top of the product development priority list. We continue getting the stock “we’re working on it…” and “no timeline to share…” responses. It seems rather illogical that MiniMed has already developed and obtained FDA approval for a stand-alone CGM with the features (tragically) absent from the 670G, yet still hasn’t provided any official information or timeline as to when connectivity will be available for the existing pump system (which is supposed to be state-of-the-art). There is no reason 670G users shouldn’t, at the very least, already be able to exchange our current 670G transmitters for an updated one that adds a Bluetooth module to the existing system. This should be similar to the module released for the old platform, yet included into the transmitter so we don’t have to carry around an extra keychain-like device. The needed technology is already present in existing Medtronic devices – there is no reason we should still be waiting.
Bradley, thanks for sharing your feedback. A Bluetooth enabled insulin pump system contains multiple components, including a CGM transmitter, blood glucose meter and a pump. The approval of the Guardian Connect Bluetooth transmitter completes one of the milestones in achieving pump connectivity. We’ve also selected a Bluetooth meter partner. Our work is now focused on having all components work together seamlessly. Once done we will need regulatory approval as well. Please know we’ve heard loud and clear that having connectivity is important and we look forward to bringing this technology to you in the future.
Why would the entire pump system need bluetooth connectivity? Couldn’t Medtronic develop a CGM transmitter that includes the radios the 670G utilizes as well as Bluetooth radios for smartphone/app support? You referenced a “Bluetooth enabled insulin pump system”. I interpret this as implying that smartphone support is never coming to the 670G and that Medtronic expects us to upgrade to a new pump system in order to obtain this functionality. It this a fair assumption?
I don’t think that’s a fair assumption at this time, Jason. While we can’t speak to what the final approved product will be, we working to make remote monitoring available. As not all customers use CGM, having Bluetooth technology built into each component provides our customers with the widest range of options possible. We appreciate the feedback from our community and will provide updates as we have them.
Having experienced the 670G for 3 weeks now, I would like to add some comments. Yes, you have heard that connectivity is important loud and clear but….. I will not have another new pump until Mid-August 2014 (our health care system provides one pump, free of charge, every 60 months. So we need a solution for this pump…not only for the next one. Additionally, when you make pumps do not think as engineers, think as users (example: given that I wear the pump on my waist belt, I get to see the screen always upside down!).
We appreciate the feedback, Pierre and this has been shared with our development team.
I concur with Bradley and Spencer posts and questions. Adding another affirmative that connectivity is a strong desire. We got the 670G for our 12 year old assuming state of the art. Dissappointing to learn this technology is not available. There must be a work around to get cell phone connectivity. Please share.