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Alert: Product and Recall NoticesIntroducing the mySentry Remote Glucose Monitor
Happy New Year! I am thrilled to start off 2012 by sharing some really exciting news with you. We have received FDA approval for the mySentry™ Remote Glucose Monitor, the first product of its kind that allows parents and caregivers to monitor the MiniMed Paradigm® REAL-Time Revel™ System from another room.
We know that many of you d-moms, d-dads and other loved ones spend a lot of tiresome nights checking glucose levels late at night and in the wee hours of the morning. With mySentry at your bedside you can see the following at-a-glance on a color screen while your child sleeps in his/her own room:
- Real-time glucose values.
- A snapshot of glucose trends through CGM graphs and up or down trend arrows.
- Insulin pump information such as amount of insulin remaining and time until the next glucose sensor calibration.
In addition, mySentry allows you to remotely see and hear all the alerts and alarms available on the Paradigm Revel insulin pump. So, for example, you could be alerted through a predictive alarm in the middle of the night if your child’s glucose levels are falling, allowing you to take action to prevent a scary episode of hypoglycemia.
Even with the mySentry monitor, it is still necessary to monitor your blood glucose independently, and all therapy adjustments should be based on measurements obtained using a blood glucose meter. But we hope that this product will help parents and loved ones like you to rest a little bit easier.
I remember back in the Spring at the Diabetes Advocate Forum talking to Meri Schumacher about her life as the mom to four wonderful boys, three of whom live with type 1 diabetes. Looking at the worry on her face was hard (it always is), but talking to her also made me all the more driven to get mySentry to market. Because I believe this will help give parents some much-needed peace of mind, especially at night.
Talking with Meri and the others at that forum also made me very excited about what’s next here at Medtronic. You see, for us, this is just the beginning. mySentry actually marks our first step in a new medical device category of Connected Care products that provide people with diabetes and their caregivers with convenient options to access their diabetes health information remotely.
Our vision is to make it easy and convenient for you to better access the data and insights captured by our integrated insulin pump and continuous glucose monitoring system (CGM) so that you can more proactively manage you/your loved ones’ diabetes. I am so excited to be working with a great team to bring these kinds of products to you and look for your feedback along the way.
For more information about mySentry you can visit www.medtronicdiabetes.com/mysentry.
IMPORTANT SAFETY INFORMATION
The real-time glucose values provided by the mySentry monitor, as received from the Paradigm REAL-Time Revel insulin pump, are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that may require a confirmation fingerstick measurement. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not based on the value displayed by the monitor or Paradigm REAL-Time Revel insulin pump.
Once you turn off an alarm on the mySentry monitor, you need to attend to the alarm on the pump itself. You cannot respond to pump alarms directly through the mySentry monitor.
Failure to monitor your blood glucose independently of the real-time glucose values provided by the mySentry monitor, as received from the Paradigm REAL-Time Revel insulin pump, may result in hyperglycemia or hypoglycemia and significant physical injury, including death.
Transmission of all data or alarms cannot be guaranteed with the mySentry system.
Please visit www.medtronicdiabetes.com/about/safety.html for complete details.
Please visit MedtronicDiabetes.com/isi for complete safety information.
Tags: connected care, continuous glucose monitoring, insulin pump, mySentry
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.
We have the mySentry and love it. But one question….in the manual it says the mySentry also works with the Guardian cgm for those who don’t pump. This blog doesn’t mention the Guardian. So does it work with the Guardian or not? And what is the cost of the Guardian?
Hi Robin, mySentry is only approved for use with the Paradigm Revel System. It’s not approved for use with the Guardian System. You can find the mySentry user guide here:
http://www.medtronicdiabetes.com/sfc/servlet.shepherd/version/download/068C0000000IxLJ
If you’re interested in Guardian, you can find more information here: http://www.medtronicdiabetes.com/products/guardiancgm
I just called about financial assistance and was told I had to pay $1500 down and then payments of $50 a month. Oh my the $480 down $160 a month is in a way better. How is this any type of financial assistance?
That great. I had an idea last night, would it be possible to develop and app on the PC to view the same information you get from the mySentry and show it as a pop-up on the desk top. My son is is an avid PC gamer and never pays attention. Having a little reminder in the corner of the screen would make him more aware. Just a though, let me know what you think
@Andy Interesting idea – thanks so much for the input! We’re exploring many ideas within Connected Care so I’ll definitely pass this along to that team.
I am so excited about this, but definitely not when it comes to price. I called and was told that it was on sale for $2400 right now instead of $3000. Was also told 20% down so $480 then the rest is split into 12 monthly payment of $160 a month. With us already paying for the pump supplies and extremely expensive sensors it’s just not doable for us. I can’t even hear her alarm when she’s in bed with me. Do have to say the alarm she had on her Dexcom was better.
@Angela We hear you and understand the cost may be tough for some families. That’s why we’re working hard on reimbursement and offering no-interest payment plans. You may want to talk to our team to see if you qualify for financial assistance and/or pursue coverage from your insurance company. You can download a Reimbursement Tool Kit here: http://www.medtronicdiabetes.net/Transformer_Form_Request_Information.
For our other readers, I should clarify that the $160 monthly payments are if, like Angela, you’re interested in purchasing just the mySentry. If you purchase the mySentry along with a new pump and CGM, you may be able to finance for as low as $50/month over four years.
Just got the email about the MySentry and watched the info video. Glad to see MMM has gotten this to market–seemed like a pretty obvious solution to have a linked bedside alarm as far back as my first year wearing a pump (and sleeping through all the alarms) in 1999. However, from the vid and info, it looks like it’s designed to keep its screen illuminated 24-7. Does anyone know if the device provides the option to turn the screen off? (Seems environmentally unethical, as well as bothersome to spouse, to have to light up our sleep space unnecessarily.)
@bryan – you can definitely dim the screen of the mySentry if you like but you won’t be able to shut off the screen light.
This is great, and yet nothing’s been done to address the fundamental problem which is that the alarms never have been, and are still not, loud enough to hear even through a monitor.
Thanks for the feedback, Nick. Actually the alarm volume is set on the mySentry Monitor and can be adjusted based on an individual’s preference. The highest volume level is at least 55 dB, which is significantly louder than the pump but not as loud as a smoke alarm (typically 60-100 dB). This volume was used because, while everyone is different, on average, 55dB at 1 meter away is enough to wake up someone who is sleeping (but it’s not as jarring as a smoke alarm).
@Mike @ Darlene We hear your concern and we understand. We know the cost of this first-of-its kind medical technology may be a challenge for some families, especially in these difficult economic times. We are actively doing what we can to ensure access to mySentry for as many people as possible including seeking reimbursement. The good news is that we have a positive track record of gaining coverage for new types of diabetes technology (i.e. CGM) with the help of patients and healthcare providers advocating for these therapies. If you’re interested in information about how to pursue coverage from your insurance company, you can download a Reimbursement Tool Kit here: http://www.medtronicdiabetes.net/Transformer_Form_Request_Information
Additionally, we’re offering a 20 percent introductory discount, no-interest payment plans for as low as $50/month, and financial assistance for families who meet certain income requirements. If you want to learn more about the financing options for mySentry, please feel free to call us at 1-800-866-4633.
For additional background, we cannot take advantage of the same economies of scale as consumer devices that are used by millions of people. We are constantly evaluating manufacturing and R&D innovations we can make to reduce product costs, while balancing this with the quality and reliability our customers rely on for their diabetes therapy.
great news! however, i dont see how $3000 is going to make my sons life easier and convienient- this is not for the majority of us parents of T1’s out there….with all due respect, only T1’s like Tie Domis’ son and Nick Jonas could afford to benefit from this….still, all in all, it is exciting technology. I’ll just have to continue dragging my lazy butt out of bed at midnight and 3 am….
Thanks for this post! This is pretty revolutionary news, and it’s exciting to hear about such a product finally being approved and able to hit the market. I am curious if MM is able to discuss at all the FDA process and any changes that occurred during/as a result of that – I’m not familiar with what’s permissible for public disclosure on this end. On its face, I would ideally like one of these myself to use with my own 523, since I often can’t hear the predictive alerts when they’re going off next to me in the middle of the night. But honestly, I simply don’t understand the cost – seems extraordinarily high for what it is, even when it might accurately be described as a “revolutionary” or “game-changing” product. But aside from that, I really like this!
This news is making a big splash all over the online community. I am excited to see what the future holds, and especially excited to see the difference mySentry is going to make for our quality of life. More sleep for the mama is a win/win for everyone in the family! Thank you for all you do!
Great news! We may have to get a CGM now.
so excited it is approved. can’t wait to get one!