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 clichÃ©. 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.
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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.
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. MÃ rta BeregszÃ szi 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.