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.
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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.
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.