This morning, Medtronic Diabetes announced FDA approval and U.S. market launch of its long-awaited mySentry Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm REAL-Time Revel System. mySentry was considered “mythical” of late by many observers, since rumors of it have circulated for at least four years.
mySentry is a desktop, or nightstand, monitor, that displays real-time data from a CGM sensor that a PWD is wearing in another room. It shows predictive alarms for high and low blood sugars, finally giving parents of children with diabetes some much-needed relief from overnight worries and the necessity to get up and check a child’s blood sugar “manually” in the wee hours. You can watch a video of patient testimonials here.
The mySentry Monitor is enabled by a small companion data transmission device (a “repeater”) called the “Outpost.” The Monitor is intended to be placed in one room (e.g. parents’ room) where it displays continuous glucose readings and delivers customizable alerts to caregivers. The Outpost is plugged into the wall in another room (e.g. child’s room) with the person with diabetes and relays data received from his/her insulin pump to the Monitor. The package also includes a 5V DC cord that powers the Monitor.
The distance between the Monitor and Outpost can be up to 50 feet or greater in a normal household environment (due to walls and RF interference) and up to 100 feet when the components are in “line of sight” with minimal RF interference, Medtronic PR Manager Karrie Hawbaker tells us.
Karrie also explains that mySentry “delivers all the same alarms as the Paradigm Revel insulin pump — including predictive, rate of change and threshold alerts — and are actually set on the insulin pump. Therefore, the customization options are the same as the Paradigm Revel insulin pump as well. So, for example, predictive alerts can be set to notify you up to 30 minutes before you reach a personal high or low target. When the parent receives the alarm would depend on what target was set. The volume of the alarm, however, is set on the mySentry Monitor, giving parents the option of how soft or loud they’d like the alarm.”
The product is available for order immediately, and is sold separately from the CGM. But customers do receive $500 off when purchased with an insulin pump and CGM. See more pricing details below.
Interestingly, the patent for this product was registered in 2008, and Medtronic held a focus group with parents at the Children with Diabetes Friends for Life conference back in 2009. Since then, there has been much speculation — and some bitterness — that this simple yet revolutionary tool seemed to have all but disappeared.
Note that two young designers came up with a very similar concept for our DiabetesMine Design Challenge contest a few years ago, called the Sleep Well, which also used a bracelet device for data viewing. The concept went viral in the diabetes community as parents clamored for a CGM data monitor that would give them some peace of mind overnight.
mySentry only works in conjunction with the MiniMed Revel, Medtronic’s combo insulin pump and continuous glucose monitoring system. But even as a proprietary product that dragged in development purgatory, it still represents a “game changer” as the first such remote-CGM-monitoring device to come to market.
Medtronic brags that mySentry “also marks the launch of a new category of Connected Care solutions that will provide people with diabetes and their caregivers convenient options to access their diabetes management information.”
The idea of a remote CGM data viewer is so simple, yet so powerful. Makes us wonder why in the world this has taken so long…
Another DiabetesMine Design Challenge entrant, Ryan Hartranft, conceived of an arm band monitor called “Easyview Sportlink” that would allow athletes to easily view their CGM data while working out. Hopefully Medtronic and other vendors have their ears cocked to these calls for flexibility as well.
From Medtronic:
The list price for mySentry is $3,000, but the company is offering the system at a special launch promotional price of $2,400 (20% discount) for a limited time. In addition, for new customers interested in getting started on Medtronic’s integrated system, the company is offering a New Patient Starter Discount, which provides an additional $500 off when patients purchase an insulin pump, CGM, and mySentry on their initial order.
The company is still working out insurance coverage of this product (i.e. none yet), but wanted us to remind folks that they provide financial assistance to their customers who meet certain income guidelines. If you think you may qualify, you can call them at 1-800-646-4633 and select option 4 to find out more.
We should ask for a sample to test-drive and review!
I was so excited reading this news this morning. Even though we have a Dex, I assume they’ll launch a similar device if this is happening. Too bad it’s so expensive, though. That definitely puts a damper on the enthusiasm.
Wow is that expensive…. Figuring it has a max life span to equal the warranty of a pump, that = $750 a year – wow
Expensive for something that wirelessly transmits data already generated and paid for by the CGM system. Otoh, I suppose it can last many years, i.e. no proprietary batteries, etc, to force repurchase. Let’s get Navigator back in the US along with Dex to create competing products and price .
Great idea………….if you are satisfied with the quality and reliability of the sensor data………
I was part of the testing for this product with my 9 year old son and it was the greatest thing ever for us. I was able to get a full night of restfull sleep knowing that it would wake me up if he went low or high. It was awesome!!
We just purchased the mysentry last week for my 5 year old daughter. First time I had a good night sleep in three years.
I’m so tired of this over priced garbage. I’m sure there could be an app for it if the minimed or medtronic would make it bluetooth or wireless… Just more expensive band-aides… I also agree with the person posting about the sendor data.. If you trust in its accuracy then good luck!
We’ve wanted one of these for our Dex so badly – very encouraging to see one approved! Yippie!!
It is a lot of money, but well worth every penny to keep our little girl safe. We have excellent accuracy with our Dex and wouldn’t be without it. We use a baby monitor to amplify alarms at night, but this would be so much better – could see trends before alarms when we are up and she is sleeping.
I also dream of a wrist watch style monitor. I would love to have that on when the kids are playing at home during the day. To just glance without having to chase her down and pull the receiver out of her pouch many times per day – that would be fantastic.
The pricing is ridiculous. As the inventor of GlucoMON-ADMS, I know what it costs to make a device like this. Shame on Medtronic.
The cost is out of this world, when you can get an ipad that for $500 and other devices that receive data from a short distance for a fraction of the cost. I feel like Medtronic is racking us over the coals for our piece of mind. I was very excited to hear they finally came out with this product so simple and wanted in the community then they price it out of range for the average family. I will have to wait for insurance coverage.
An iPad doesn’t require FDA approval. That’s the expensive part, folks, not the machine.
It’s a communication device that repeats information. An advanced baby monitor. More price gouging IMO. These overpriced gadgets are what create problems with our insurance companies when we ask for extra glucometer strips or pump supplies. My WIFI repeater only cost $99. Maybe they could have charged 3x times the price, not 30x. I’m sure they would have still made a profit.
Are you kidding me??!! When I read they were giving 500 off if you buy a pump, I thought, wait, how much does this thing cost?! I nearly fell off my chair when i read the price. That’s MORE than the CGM itself!!!!!! The revel cgm kit is like less than a grand, and the gardian kit is like 1200. You want more than twice that to do what the gardian should do anyway, which is receive sensor input from more than 3 feet away? Seriously? This pricing is an INSULT!
(BTW, if you order the gardian kit, ins will still cover it, your gardian and revel will both receive the same signal at the same time, you can put it on the bedside table to hear the alarms, and you can clip it to your watch to check bg when jogging. It’s the best kept secret MM has.)
Question to the electrical engineers out there – Does the seemingly insane pricing have anything to do with fact that CGM system probably does not have the battery power/lifetime profile to transmit to a baby monitor /w receiver maybe 30-75 feet away from the sensor location and thus requires either a highly sensitive receiver with special electronics to pick up only an interference free sensor signal or some kind of additional near field device which can first receive the sensor info and then transmit this info to the more distant monitor??
@AmyT — you mention that this device was patented w/ focus group in 2008. where did you get this information?
@Wil — speaking of FDA approval, have you (or any one else) seen an actual PMA or 510(k) for this device? I can’t seem to find one.
Telcare launches their all-in-one cellular blood sugar meter next week. Cost is on par with a plain old meter and it required a 510(k) plus all of the quality system requirements that go with it. Has anyone asked Medtronic for their pricing rationale? It’s only fair to get their perspective added to this thread.
We use a dexcom like this already– I keep it next to my bed in a different room, or in the hallway between our rooms. And it picks up the signal from my son’s bed. We’ve done it for years. No extra cost. Try it. Maybe I have thin walls or just a good dexcom? From my experience dexcom is also more accurate.
I think some people need to be realistic. My son has been on a Medtronic pump for 8 years. To compare this type of technology with an iPad is slightly ingnorant. This is not something you can buy at the mall or Walgreens. If you have a problem with the cost then blame the FDA, not Medtronic. The amount of money a company has to pay to get new items approved is crazy. I’m sure Medtronic paid millions and millions of dollars to gain approval for this device alone. Remember 5 years ago with the cgm was released, it had 0% insurance coverage. Now 90% of insurances cover it. Everyone who loves their Dexcom should thank Medtronic for getting the codes created and lobbying for their approval. The codes Dexcom use are the codes Medtronic created. The Dexcom works better for others. Everyone is different. My son is in college now so we have no need for this device in our home but I think it is spectacular that they are putting up the money to get something like this to market. As far as bluetooth is concerned that is the most unreliable frequency you can have. The FDA required specific things to get this thing approved. Last but not least the last time I checked Medtronic was a for profit company. They dont create new products to sell for a loss. If they start I will sell my stock!
http://annualreport.medtronic.com/year-end-highlights/index.htm
Medtronic paid $2.5 Billion dollars to investors (approx. getting a 19.5% return on their money).That’s only a portion of their profit. All that profit came at the expense of patients, hospitals and insurance companies and was over and above their cost of getting products approved by the FDA. Their site claims 38% of their revenue is from new products and that they have 35 years of increasing their cash dividends (i.e. profit).
BTW, is this considered a medical device? Probably not, just a communication device (optional, at that). Probably only needed to be approved by the FCC.
I have a theory on the cost of this device.
to keep the transmitter of a CGMS system SMALL and with a relative low wattage and thus small battery, the transmitter ONLY transmits; it does not interpret.
What I mean by that is that Medtronic’s system uses an electrical signal they call ISIG. The ISIG is the thing being transmitted to both the pump, and this new device. But the magic of turning that ISIG into a usable blood glucose result relies on the proprietary software algorithm.
This means that this device is unlikely a simple receiver of a signal, but requires the same internal chipset and software that the insulin pump itself has.
Is it overpriced? Maybe – but don’t equate it to a device that only needs to receive a signal.
The pump is sending the converted data (glucose, alarms settings, etc) to the Outpost repeater which then sends it to the mySentry (because the inserted transmitter is only large enough to transmit to the pump. So the outpost is a stronger transmitter to get it to the other room. Highly unlikey the monitor is doing anything but receiving and alarming. There is that separate volume control though. A repeater and a clock radio all together.
The features of this are great in theory, especially for monitoring children with Type I, but the actual glucose sensor in the Medtronic Revel system leaves a whole lot to be desired. When Dexcom (which already has a pretty good range and a very bright light and loud alarm) adds smartphone capability to their excellent CGM, then I’ll be interested in the concept.
@susan f
Good theory. It isn’t clear in the description “relays data received from his/her insulin pump to the Monitor.” This could mean direct from the sensor or from the CGM algorithm in the pump. I’m guessing mySentry is essentially acting as a wireless repeater with an attractive display screen.
The saving grace to the high price tag is it might last many, many years since there are no moving parts?
Hi There – my name is Karrie Hawbaker and I’m the Public Relations Manager for the Diabetes business of Medtronic. I wanted to let you know that we hear your concerns about the price of mySentry 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 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.
How do you justify the cost of this device? Yes it’s useful, but why so expensive? Thanks.
Jason, don’t use the FDA as a cop out to protect your investment in Medtronic. The FDA approval is only required for insurance coverage/reimbursement. This is a remote monitor.
The reality is that we are getting hosed for all of these silly little medical devices that are no more powerful than pager. It’s a joke and we all know it.
@John. Everything medical related is reviewed by the FDA. The FDA charges the companies a tremendous amount of money for this process.
I bet you have cable or satellite TV, right? Why would you pay $100 a month for something you can get for free using an over the air antenna? It’s just a frequency receiver. Whey would anyone pay for such a device. Oh, but I bet you can’t be without your cable! It boils down to what you perceive valuable. Look around you at all the convenience items you have that you paid top dollar for. Someone has to do the research and development on these products. I applaud Medtronic for spending their money on a product that isn’t for the masses, but for a few individuals who really need it. They could be developing insignificant gadgets that you would drop $$$ without even blinking because YOU want them.
I am intrigued by this product. I do so wish the display included the level of active insulin and included a way to remotely control the pump/respond to alarms.
Clarke,
Are you saying the high costs are on the FDA or the fact that its a small, limited market item? Or both?
Maybe they should have put a $5000 price tag on it and hope the insurance companies cover it so our health care costs can really skyrocket.
Bottom line, its a glorified receiver in a shiny skin and nothing more. IMO – its a rip off.
I purchased the mysentry this week for my daughter. She is five and we have long suffered night time lows since she was two. This device may be limited in its abilities, but the peace of mind in knowing that I’m not going to sleep through a low alarm makes it worth the expense
My son has been on a MiniMed pump since August 2011. We have had nothing but good experiences with Medtronic. They helped us get the pump for just the cost of a prescription (because our health insurance doesn’t cover ANY of it, but if a Rx is written, it DOES get covered) – we paid a whole $35 for his pump (plus 2 more co-pays for supplies). The CGM’s, sensors, and transmitters are the same cost. mySentry is a one-time fee of $2400 (right now, anyway). My thought is: mySentry is actually CHEAPER than I expected considering the exorbitant cost of getting it approved through the FDA. And when you think about it, mySentry costs less than the pump, itself, and that’s been out for years now. Medtronic has been a wonderful source of support and information since we’ve had the pump. I don’t understand everyone’s animosity and criticism towards the company or this revolutionary technology.
Medtronic main focus for this is for the parents with young children with Type 1 diabetes (though there are some benefits for adults to).
Think: Glucose baby monitor.
I’ve seen one and am actually very excited at the possibilities. When you think about it, parents with young type 1 diabetics have to get up several times to check their child. If the child is a light sleeper, it may even mean waking up the child.
The larger monitor screen can go on the parents’ bedside table and they will constantly be updated with their sleeping child’s glucose levels.
The alarm is louder than the CGMS since it was not design to be used in public and doesn’t have to worry about being discreet.
(Since the alarm is louder, I could also see another possible is in a situation when an adult type 1 with hypoglycemic unawareness who lived alone. )
I’m working on a smartphone app that recognizes the sound of the alarm which then rings your cell phone. The technology is just like what is used to identify song titles (ie Shazam) on iPhones and Android OS smart phones. I’ll use this for my daughter and it will probably be a free download. Does this sound interesting to anyone but me? I first described this app to JDRF, US Army and NIH back in 2003 but they weren’t interested because there would be no commercial market for it. With the current phone technology it’s not that big a deal and no need to commercialize.
Kevin, I’m a programmer myself and a diabetic for for the past 4 years. I would be interested in helping you code the app for the iPhone and Android, or at least to be able to contribute functions to your app. I’ve been interested in this kind of medical technology for several years. If you are interested, maybe we can make this an open-source project?
Email me at razi.khaja@gmail.com
[...] NewsFlash: Medtronic Releases MySentry Remote CGM Monitor …Hi! I’m Lenny the Lion, an ambassador for children’s diabetes education. I was diagnosed with diabetes when I was small and I am an insulin pump user. I don’t … [...]
John, that sounds VERY interesting to me. I’d love to be able to ditch the monitor and just use the smartphone too.
Denise-can you clarify this? (BTW, if you order the gardian kit, ins will still cover it, your gardian and revel will both receive the same signal at the same time, you can put it on the bedside table to hear the alarms, and you can clip it to your watch to check bg when jogging. It’s the best kept secret MM has.)
We are getting Ds T1 his first pump and would love something to help us get an alert when he is trending low at night.
have had the mySentry since Jan. 13 and can’t live without it. My daughter hasn’t missed a day of school since we started using it….have managed to treat both nighttime highs and lows more effectively because I’m not afraid I will sleep through her pump alarms. Yes, it is expensive but there is nothing more important to me (except a cure)…
I did question Medtronic about the cost…answer: we need to remember that the pool of potential customers for this product is actually pretty small and the cost of R&D needs to be recouped. Personally, I think the mySentry and the CGM should be sold packaged together.
Finally, the CGM/mySentry isn’t perfect but it is one more piece of the puzzle to manage T1. And now that my daughter is considering switching to the Omnipod, I would keep her on the medtronic CGM so I can monitor her nights and give up the ability to read the CGM data on the pump during the day.
I have the MySentry and have a lot of comments to post about it on here. First thing is that the person wearing the CGM has to always be within 6 feet of the outpost. So that means if your child sleeps somewhere and there is not an outlet 6 feet away, the MySentry is useless. And if the child gets up and moves somewhere, like in bed with the parents, the MySentry again will not work.
From dealing with Medtronic and the MySentry, I fell they have a very deceptive practice going on. We of course ordered the MySentry with the Insulin pump to get the best discount. But understand this, they want you to give it a month or more of dealing with the insulin pump before trying to get the MySentry going. I guess they don’t want to overwhelm you with learning the pump, and the CGM at the same time. But the funny and deceptive part is, that there is only a 30 day return policy on the MySentry. So I tried to return it, and to my amazement, they said as long as I inserted the CGM into my son for so many weeks and tried it out that they would return it. Well, guess what, I did all that Medtronics wanted, and got treated very badly and my return got refused. On another note, Medtronic uses a third party billing company to bill you and make payments. And there was no $50 a month payments. They give you one year to pay it off and payments are $123 a month. And in my case they put the wrong zip code in when sending my info to the third party billing. So you can imagine my surprise when they finally got a hold of me and said I was 140 days overdue and owed like $600. And the best part??? They actually threatened that my son would no longer get any diabetic supplies if I did not pay up!!!! That would be nice to know before purchasing this product Medtronic!!!
Luckily the billing was straightened out, but disappointed and very upset the way I was treated by Medtronics with the MySentry. The reps are very mean and talk over you constantly. They lie to you and basically try to shove it down your throat that you must buy the MySentry to manage diabetes. All I know is that when my time is up with this pump, I will be finding another company to go with. And by the way, the warranty on the MySentry is only 1 year, not 4 like the insulin pump.
@Kevin
I am not a programmer or anything but have had some ideas about an app also. I do have a friend that knows alot about programming and such and can build apps, but never has time. I would be interested in chatting with you and maybe give you my ideas about an app,
Really, I was all excited about this and then when I saw the price for it, it was a sad moment. You darn well know that this probably cost them $100 bucks if even that and then you want to mark it up 5000%…that’s just pure money hungry. I think the oil company’s and Diabetes folks have the same Long Term Plan…take money from the people. Most insurance companies don’t cover this. I’ve been with Medtronic since being on a pump and I’ve just gotten more and more disgusted with them and going to look elsewhere. Great product, but the problem is that your keeping it from the folks who need it because of the cost!