Right after the first of this year, Medtronic Diabetes announced FDA approval of mySentry, a remote monitoring and alarm system for their Revel CGM-enabled (continuous glucose monitoring) insulin pump. D’Mine Columnist and Correspondent Wil Dubois, also author of the award-winning CGM handbook Beyond Fingersticks, has been field testing one of these new systems for the last month. He’s quite enthusiastic! Don’t miss his thoughts on this whole new category of D-management tool:
By D’Mine Columnist / Correspondent Wil Dubois
Game changer is an understatement. Paradigm shift is too cliché. Revolutionary comes close. Oddly, there’s really nothing that special about the technology. Nevertheless, I believe it’s the biggest thing to hit pediatric diabetes in 95 years — the biggest thing since the invention of insulin.
With FDA approval of mySentry, the stage is set for a whole new category of diabetes devices that beam information — CGM data, pump status, alarms and more — to remote systems in real time. But beyond this, which is no small achievement, just what is mySentry? How does it work? What are its limitations? Who can benefit from it? Is it worth the cost, and just how much did you say it was?!
What it is
mySentry captures a ton of data from a CGM-enabled pump, and relays that information, along with blood sugar readings, up to 100 feet away. mySentry has two components: an alarm clock-sized monitor, in the form of a table-top viewing screen; and a small companion “signal booster,” or data transmission device, called the Outpost. The beauty of it is that a caregiver in another room can glance at the monitor’s color screen and see all the key metrics of the linked pump; and if the pump sets off an alarm, that alarm is relayed to the monitor.
What it isn’t
mySentry doesn’t turn your home into a CGM wireless hotspot. For mySentry to function, the pump has to be within six feet of either the monitor itself or the Outpost signal booster. It’s no damn good if the kid with diabetes is running around all over the place. But for nighttime and naptime, it rocks the house as a way for parents to keep an eye on the diabetes status of their little type 1s when they’re most vulnerable.
How well does it work?
Damn well. I’ve been using a mySentry unit on myself for the last five weeks. I guarantee you it’s well thought-out and well-engineered. It’s accurate. It merges all the key pump and CGM data into one place and uses a graphical interface that makes it intuitive and visual. To me, it’s like a diabetes dashboard. I glance at it and know how fast I’m going, what road I’m on, how much fuel is in the tank, and if there’s any road construction ahead I need to worry about. And if I’m not paying attention, it still is — Revel’s predictive alarms sniff out trouble well in advance, and the system gives me and my family a head’s up before the you-know-what hits the fan. My wife has given it rave reviews, too. While I was down with stomach flu recently, she used it to keep tabs on my blood sugar while I was sleeping.
Wil's Revel pump
Most importantly to me, its alarms are loud enough, a major weakness of the Revel pump itself. mySentry makes a musical xylophone-like alert tone that can be set very, very LOUD, indeed. Or as I like to say, “loud enough to wake the dead so that you don’t join them.”
It’s easy to set up, easy to use, and requires no official training. After you take it out of the box, you can have it up and running in under 15 minutes. And while I’ve had some well-documented trouble with the Revel pump itself, the mySentry system has performed flawlessly.
So who’s it for?
mySentry is really engineered for caregivers, most especially the parents of type 1 kiddos. If you’re a type 2, or an adult dx’d type 1, you probably don’t know this—but most parents of little type 1s get up several times a night (or at least once at 3am!) to check their children’s blood sugar. Every night. Night after night. Week after week. Month after month. Year after year. For years. Why? Because nocturnal hypoglycemia is a real, persistent, common, and dangerous threat to type 1 kids. Which means the worst time for the parent of a little type 1 is when the sun sets and all the mythical fears of the night become very real.
In a study published in The Journal of Pediatrics, Dr. Màrta Beregszàszi and her colleagues estimated the prevalence of nocturnal hypoglycemia in type 1 children and adolescents is a whopping 47%; and nearly half the incidents were asymptomatic—meaning the children felt no symptoms of the low. Another study by Dr. Alexandra Ahmet places the prevalence as high as 68% and notes that 75% of all severe hypos in kids occur at night. And if that doesn’t chill your blood, consider Dr. Francine Kaufman’s 167-night CGM study of young boys that found in a full 27% of the nights, the boys dropped below 40 mg/dL in their sleep, and that the length of time they spent low was longer than previously believed.
Dollars and sense
mySentry is being offered at an introductory price of $2,400, until the end of this month, and then goes up to $3,000. That’s just for the monitor and the signal booster, which only work with a Medtronic CGM-enabled Revel pump. At least mySentry has no consumables—so once you buy it, your only ongoing cost is the electricity to run it.
It’s a price tag that’s caused a lot of anger in the trenches, but didn’t strike me as unusually high for a first-in-category device. Let’s face it, mySentry is an add-on product to a developing category that’s still losing money. Thinking about it that way, I don’t think it’s fair to accuse Medtronic of price gouging.
Wait a second, won’t our health insurance pay for it?
Whether or not mySentry will be covered by your health insurance remains an open question. Medtronic created a tool kit that outlines the hoops you’ll need to jump through to try, but even with this help, I think it will be an uphill battle to get mySentry covered. There’s no doubt in my mind that having a mySentry in the house of a type 1 child will greatly reduce the wear and tear of the child’s diabetes on the parents ― but, frankly, that’s really not the insurance company’s problem. They’re only interested in whether or not it will reduce the health care cost of the child, and that’s a harder case to make.
Medtronic is being realistic about the long odds, too. They’ve also included a sample appeal letter in the kit, and have warned parents to be ready for a cumbersome process requiring multiple appeals.
So is it worth it?
Every child is different, and calculating the value is a formula that each and every family has to work out on their own. But two things are certain:
First, a whole new category of diabetes device has been born, the final evolution of which we can only dare to imagine.
And second, if nothing else, for many parents of type 1 kids, Medtronic just introduced the cure for the epidemic of grey hair and sleep deprivation that plagues them.
Once upon a time, I remember a claim that Ford cars would ALSO display Medtronic CGMS info – does anyone know what ever happened to that?
NO NO NO NO NO NO. This is NOT the revolution you think it is and here is why: The Gardian ALREADY works with the Revel AT THE SAME TIME. So you calibrate the gardian, set it on the night stand next to your kid and you can hear all the alarms from the next room. The draw back is that the range is so limited that the gardian has to be in the same room as the kiddo, so you can’t have it by the parents bed so we don’t have to get up.
“Most importantly to me, its alarms are loud enough, a major weakness of the Revel pump itself.” It also is correcting the range weakness of the gardian. So how is it a reveloution?! It’s just correcting and alarm volume weakness of the revel and a range weakness of the gardian. Why not just work on the faulty products you already have out there?!?! B/c then you couldn’t charge THREE TIMES the price of the gardian!!!!!! Which insurance WILL cover btw even if you already have the revel. LOTS of parents use the revel AND the gardian at the very same time, especially over night and medtronic staff doesn’t even seem to know this works and NEVER recommends it to ppl when they want to order a cgm to go with the revel. A MONITOR for a cgm should not be worth more than 3X what the actual cgm costs itself. The price is appalling and I for one am irate–in case you couldn’t tell.
Brian says:
April 25, 2012 at 6:51 pm
Yes, expecting an alert, or announcement from a system like this is very fine and useful. But are there ways of making sure that an alert won’t be needed? Yes …..
The blood sugar test result is indeed valuable. But it is more than a diagnostic aid to your consultant! It can be used by a diabetic to help through the day in calculating what the blood sugar will become. You enter brief details of each insulin injection into a computer programme. You also enter the carbs and time of each meal. If you then enter the result of a blood sugar test, the programme tells you whether your blood sugar will end up at the right level when all the food and insulin that you’ve taken have done their work. And it tells you if you need more food, or insulin, and if so how much, you still need to take to get your blood sugar back on track. The programme is available now at low cost. And it works. Have a look at http://www.pathfinderweb.talktalk.net for details. This software takes diabetes blood sugar control to the next level!!!
Reply
I’ve worked with the mySentry for months, I am a big fan of it. Do I get more sleep? No. Alarms are alarms. But when I do sleep, it is a more quality sleep. This technology represents a whole new world coming forward. Before we know it the graphs will be tied to our phones. The first step is always a small one…and I preceive that many small steps will come forward after this…but in the end the fact that the FDA approved this technology is a game changer. (In my opinion anyway.) Anything that connects me to my boys and works in the favor of safety is a win in my book!
I’m excited about new technology in general — but for our specific case we’re still not ready for the CGM. My daughter is 6, she is tiny, and has just a wee bit of realestate for her pump sites. I’ve heard the CGMsite in more painful than the pump site and of course means 2 overall sites. So, as long as we can keep her A1Cs below 8, we’ll do the midnight and 3 am checks on our own. BUT, did I hear something about a single site for both the CGM and pump? Now that would get us using the CGM asap!
This is such utter (BS). This kind of functionality could easily be implemented as an iOS app with a small proprietary hardware attachment — when Apple opened up access to the dock connector in 2009, they specifically demonstrated by bringing up a glucose monitor onto the stage (LifeScan and non-continuous, but still). Instead we get proprietary hardware because there’s no way they’d get away with pricing an App Store download at $3900 (remember Apple’s 30% cut as the middleman). Anybody else remember when Deltec was charging $30 for the cap to the Cozmo battery compartment? This is just more of the same. I know FDA approval can take a while, which can partially explain why medical technology lags so comically behind the rest of the world (three years later, where’s my LifeScan attachment?) but a product like this only makes it out because we’re stuck in an abusive market where the actual patient care is just a secondary concern. I can use a free app to check on the progress of my stupid BitTorrent downloads using multiple devices over any 3G, wifi, or EDGE connection, but when MedTronic gives us a six foot range with a $3000 proprietary device we are supposed to be impressed? It’s been more than five years since Amy first wrote about this [see diabetesmine.com/2007/04/an_open_letter_.html] and almost nothing has changed. Medtronic, please get your (sh*t) in gear already, people live and die by your products.
Wil, thanks so much! I’ve been anxiously awaiting a comprehensive review of MySentry.
Muffled in your review is that this system could be a valuable tool for Type Is like me on the pump & CGM. Being hard of hearing, I never pick up on an alarm at night and rarely during the day. Even the “vibe” escapes me all too frequently. I have night time lows all the time and sleep through all too many of them. With mySentry the possibility of ending that dangerous and scary situation is within reach except for one thing – the price is impossible for this old, disabled vet on a pension.
I would say that the MySentry would be great for the hearing impaired. Neither my husband and I hear the beeps of the ParadigmRealTime and my husband sleeps through the vibrations, too. My husband has Addison’s as well as type 1 with asymptomatic hypoglycemia (hypoglycemic unawarenss). The combination means he is high all day and low all night–
I kid you not. But $2,400? Yikes!
Tom and Diana–Tom, get the gardian! You put it on the night stand and it receives your data just like the revel, like 2 radios tuned to the same station.
Diana–put the gardian unit on a hard surface, like the nighstand. If he doesn’t hear that put it on vibrate and put it in a glass. If he doesn’t hear that, put some coins in the glass. If he doesn’t hear that. then hwe won’t hear any alarm b/c that gardian on vibrate in a glass full of pennies will wake the whole block.
I wonder about the accuracy of this comment: “.. most parents of little type 1s get up several times a night (or at least once at 3am!) to check their children’s blood sugar. Every night. Night after night. Week after week. Month after month. Year after year. For years.” I think there is lots of pressure on parents to do this, but I’m not convinced of the necessity. I have a 26 year old son, diagnosed at age 8 weeks, and I rarely did checks during the night. Re: low alarm sounds, a baby monitor can be set up in the child;s room, with the receiver wherever the parent is, for a tiny fraction of the cost of this system – and it will work with any pump. No fancy graphs, but it will alert parents.
Hi Judith,
I just wanted to point out a couple things. First, with Medtronic’s CGM, the alarms are coming from the insulin pump. For most people, the pump will be clipped to PJs, and will be under the covers during the night. If it doesn’t wake up the person wearing the pump, it’s unlikely the alarm would be sufficiently audible to anyone else via the receiver. Unless you were envisioning something else…
Second, I’m the same age as your son and my parents rarely woke up to test me either! But I have noticed a trend toward testing frequently at night from parents with young children. Perhaps it is a difference in how you / my parents were instructed, but Wil’s statement is definitely accurate.
Seems like you would want to price this more favorably to drive the growth of the CGM market as it’s wedded to pump technology for larger demographics and thereby start greasing the skids for the continuing move towards a full blown AP.
Medtronic is selling us out-dated technology at a premium price and putting lives at risk. Increasing the volume of the pump alarm or making it user-customisable would cost them next to nothing to include in their pumps (it’s not as if they have to invent the technology).
Has anyone in the United States considered making a complaint to the FDA (or the relevant authority) about the fact that the alarm on Medtronic pumps is inaudible in most everyday situations? Where would Medtronic stand if it could be proven that a person with CGMS died after their pump alarmed throughout the night but they couldn’t hear it and therefore did not wake up to treat a low. Could they be charged with manslaughter considering that the alarm is a known problem?
Unfortunately, I am in Australia and I believe that if we made too much of a fuss over here, Medtronic would simply withdraw from the market.
Medtronic’s internet banner “Medtronic Diabetes — leading the way since 1983″ should read “Medtronic Diabetes — still stuck in1983″.
I mean, God forbid they release something that RUNS ON A COMPUTER…
I don’t get the hype for this tool. Like most diabetes technology, its over-hyped and over priced. Omnipod is far cheaper than the tubed pumps and performs similarly.
I’m still waiting to see just how ‘groundbreaking’ this AP will be since the JDRF is force feeding it to the public. But, they (JDRF) receive $250,000 per year from Medtronic so its no wonder they are moving away from supporting the Cure. In real dollars, since 2008, they have spent less and less on the Cure but have no problem holding/advertising all their “Walks” and “Galas” in the name of a Cure. To confuse donors even more, they lump preventive research and cure research together. How about an indepth article with Brewer, Insel, or Kowalski and not letting them off with the coporate tag lines they are so well known for. No more fluff, hold them accountable to the gross lack of progress at the bedside.
MySentry should cost no more than $500.00 bucks and just because they expect insurance to pay for it or a portion of it depending upon the plan, doesn’t mean they can rip off the consumer without coverage.
Has anyone ever asked why the consumer doesn’t get the same rate as the insured?
This infuriatingly stupid trinket is 10% productive technological progress and 90% predatory pricing aimed at parents who are rich, well insured, and scared. It would cost no more than five figures to write the software to display CGM graphs on multiple screens, even remotely over cellular data networks, and play alert tones when the value drops. Multiply by a factor of five or ten if you want to account for the FDA and administrative costs or whatever; let’s just shut that argument down right away. There’s no reason for this product to exist nor for it to be priced so offensively.
Meanwhile, this is the kind of “access” we get instead:
http://www.bloomberg.com/news/2012-02-29/mcafee-hacker-says-medtronic-insulin-pumps-vulnerable-to-attack.html
MySentry and tubed insulin pumps are a fine example of out of control healthcare costs in America.
The FDA argument is not valid since the pump technologies have been around since the mid 80′s.
Maybe Medtronic is trying to cover the costs they incurred from the pickle they got into with their pacemaker devision.
http://www.ennislaw.com/medtronic_pacemaker.html
I will never go back to Medtronic for anything……… I hope a cure for T1 is found and it has nothing to do with the JDRF.
I am a Medtronic employee and I take calls all day long from pump patients and their parents. A few weeks ago, I was speaking with a father of a child who was diagnosed at 10 months of age. He had been on pump therapy for a year and his father had just purchased MySentry and only had it up and running for a few days when I spoke to him. He told me that the previous night was the first night since his son was diagnosed that he actually was able to sleep. The way he spoke about how it has improved his child’s life and his own was so touching that I couldn’t help but start crying on the phone.
Its money = piece of mind. People buy cars thinking monthly payment, people pay for internet, smart phones, 4 wheelers, boats, snowmobiles…all TOYS for occasional use. This is a life enhancing TOOL for use everyday!
Sorry, I do NOT understand the whining?
“Sorry, I do NOT understand the whining?”
It’s simply this. This product only addresses the lack of loudness of the revel alarms and the lack of range in the gardian, yet it costs 3 TIMES as much as either!!! And we can decide to cut back on toys and games but how do we decide that our kids don’t need to be safe at night?
Nice coverage, Wil.
I hope over time more parents of children with type 1 can gain access to this.
I’d want one if I was in their shoes.
Heck my husband would like this along with a CGM for me.
Due to money, I’ll just continue to not give insulin near bedtime, keep my dinner carbs low glycemic, and try to keep my activity levels consistent (things that are nearly impossible with children).
I understand the feeling that people have regarding the cost, but there are some things to consider based on the comments I’ve seen here.
1. Nobody want’s their loved one to be found dead in bed.
2. It is well documented that there are major health issues that can arise from lack of quality sleep. We have caretakers that are sacraficing their health for the health of their children. While every parent would do this to protect their child, isn’t it beneficial to everyone if they don’t have to? Additionally, these sleep deprived parents are the same ones who are more than likely shuttling their children around from one activity to another, and are potentially placing themselves, their children, and the public at large in danger when they get behind the wheel in their sleep deprived states.
3. Concerned with the cost? I am too! But we should consider this. While the possibility exists for a jerry-rigged solution such as baby monitors (ARGH!) and Guardians in glasses, you are only taking care of one aspect. The alert. This device allows you to also see everything else that is going on with the pump without disturbing the child’s sleep either. Also, the cost will hopefully come down as time goes by. Anyone familiar with technology knows there is a price to be paid for being one of the early adopters. As the landscape is primed for more and more use of this device, it will allow the company to make larger production runs, which will allow for cost reduction. Think of it like shopping at a warehouse store. Buy more, pay less.
4. For those who feel this should be a smartphone app, there are several major hurdles.
a. The smartphone is not a medical device. It is a computer with an operating system. The operating system with instructions on how to make a device do things. There is NO COMPANY that would take the risk of putting thier name on a product that they cannot have total control over. The potential for lawsuits is too great.
b. The rapid iteration of the smartphone industry makes it impossible to make something that would pass FDA scrutiny. We all know how long it takes for FDA approval!
c. We want something that would communicate with our phones, except short of a direct cable connection, there are transmission and reception issues involved with any wireless medium that would greatly reduce the ability to place confidence in the product. Imagine living in an apartment building, or dorm, or even a residential neighborhood with many competing access points. (I’m not talking about different SSIDs. Remember there are only so many channels that you can transmit on in the spectrum assigned to wireless.) You complain about connectivity now, and yet you want to put your health monitoring device on the same medium?
This is the reason why the FCC has certain uses for certain frequency ranges in order to provide a high level of availability for wireless communications. Imagine Emergency Services not having their own frequency range and having to communicate on CB Radio. The results would NOT be comforting. So to get around that it would mean having to put specific radios into the consumer smartphones. While there are a lot of diabetes patients this would only be a small substet of their market, and not one that would be worth investing into.
That said, I’m signing for our Sentry tomorrow.
Minimed is suggesting MySentry to me after my complaints of poor visibility of the Paradigm screens and inability to hear alerts. I am an adult type 1 pumping for over 15 years and near 25 years since diagnosis. I was attempting to get an out-of-network exception to go with the Omnipod or T-Slim with the Dexcom 7 +, but was denied by my insurance carrier. Metronic is the only in-network provider they offer and I currently have a Paradigm 523 whose warranty expires mid-August. I am having to depend upon the ears of co-workers, my husband or our dogs to hear alerts of the pump or CGM. I am forced to magnify screens on the pump to program certain features. There is no guaranty that my carrier would cover the MySentry unit. I don’t know whether to pursue and appeal to try for another pump or go with the Revel who offers no improvement to audio alerts or screen visibility.
We have been using MySentry for a week now.
IMO, it ain’t ready for prime time.
1. Range restriction in relation from the cgm to output is a bit to restrictive. The six foot circle is too restrictive, especially for a teen. This also wasn’t what we were led to believe from the Minimed reps at a product fair. They implied it would work through out the house, not in a set, six diameter circle, through out the house.
Further, it sometimes tends to loose data connection when the pump/cgm unit falls under his body while sleeping. Thus waking me up with an alarm that it can’t read the pump. In other words, it is prone to false alarms.
2. The lights on the outpost are just too bright, and can’t be dimmed. The solution was to throw a towel over the device, thus potentially shortening an already very tight range.
3. The display on the MySenty is too bright can can’t be dimmed very much. It’s almost a touch screen device. Surely they could have engineered the screen to timeout/go dark and wake up with a button touch or alarm.
Overall, I think it is a cool idea, but has several shortfalls that should have easily been fleshed out in the product development/user testing stage. Definitely not worth the price paid to be Medtronic’s beta tester.
I agree that you can barely hear the alarms on the Revel. Medtronic needs to work on that first. Planning on a CGMS this year. But I feel that the alarm would not be sufficent. The only one that really notices the alarms on my pump now is the dog, when it vibrates. Her head pops up and and she has this “what was that?” look on her face.
Intersting, my dogs are my ears as well for the pump alerts. My husband works swing shifts and third shifts are tough for me without having him there to hear alerts. I guess I need to persuade my employer to let me bring my dogs to work.
My husband is a type i diabetic with sleep apnea. His CPAP is so loud he doesn’t hear the alarms from the pump. He is also unaware when his sugar goes low. Since he also has dementia, he is totally unaware of what goes on during the night. The MySentry is a blessing to me because I can hear the alarm, look over and take immediate action. I know they market this as for children but adults with mental illness need it too.
I am now attempting insurance contribution for the MySentry without first buying the unit out of pocket. My insurance carrier is honestly interested in doing so but in working with Medtronic they can’t get past the fact that the Mysentry doesn’t have insurane codes tor billing purposes. I have informed the rep at Medtronic that it is frustrating to me in that a carrier is interesting in covering the unit but Medtronic is not cooperating. You would think they would want to pursue this to progress down the path of obtaining insurance approval for these units and not turn a customer away.
[...] the parent of a child with diabetes, my opinions about the new-to-the-market and highly praised Medtronic MySentry CGM monitoring device might be [...]