FDA Approves Medtronic mySentry, Allowing Parents and Caregivers to See Real-Time Insulin Pump and Glucose Trend Information from Another Room

Earlier this month, Medtronic announced that FDA has approved mySentry, a remote monitoring system that enables parents and caregivers to see real-time insulin pump and CGM information from another room – this should be a welcome tool for parents of children with diabetes who worry about severe nocturnal hypoglycemia, or for caregivers of patients who are less aware of hypoglycemia. The device is approved for use with the MiniMed Paradigm Real-Time Revel insulin pump (see our Test Drive in diaTribe #23) and has two main components: a monitor that displays CGM and insulin pump information (e.g., at the bedside of a parent or caregiver) and the ‘outpost’ that relays information from the insulin pump to the monitor (e.g., in a child’s bedroom). The monitor has a sharp-looking color screen that displays the most recent sensor glucose value in large font, CGM trend arrows, and status information (insulin pump status, battery life, insulin remaining, and time until next sensor calibration and change). The icons on the display are color coded green, yellow, and red, which should give sleepy parents and time-pressed caregivers a quick and easy way to know what’s going on.

The Medtronic mySentry is immediately available to US customers who have a prescription. The $3,000 mySentry is unfortunately not covered by insurance at this time, although we believe that “exceptions” will begin to be granted with documentation. To ease the financial burden, Medtronic is offering it at a 20% discounted launch price of $2,400, with a further $500 discount for new Real-Time Revel pump/CGM users. As we understand it, Medtronic is currently in active discussions on the reimbursement front and evaluating studies to demonstrate the benefits of mySentry. While we do believe insurance companies will eventually pay for the device, it’s unclear how long this will take or what level of evidence will be needed.

In a 35-family user evaluation study (2011) conducted by Medtronic, feedback was very strong, and virtually all families found the device to be valuable. A reported 100% of parents surveyed believed that the mySentry alarms and alerts were loud enough to hear while sleeping at night, over 90% of mySentry users surveyed would recommend mySentry to other parents or caregivers, and 100% of parents surveyed reported that mySentry was easy to use. While such surveys may not be typical, we believe that a significant number of parents would like and use the device if they could afford it. A quote from a highly respected Medtronic engineer and type 1 parent Lane Desborough after his experience with the device said it all: “The two worst days of my life have been (1) when my son Hayden was diagnosed and (2) when we had to return the mySentry from my personal testing of the device.” –For those interested in learning more about the mySentry, we suggest visiting the product’s website at http://www.medtronicdiabetes.net/mysentry. –AB