Medtronic remote diabetes monitor gets U.S. approval

Medtronic Inc on Wednesday said it received regulatory approval for the first remote glucose monitor that will let parents check the blood sugar of a diabetic child sleeping in another room.

About three out of four severe hypoglycemic reactions, in which a diabetic’s blood sugar drops to a dangerously low level, occur overnight. Parents of children with diabetes typically get up several times a night to check whether the child’s blood sugar is within healthy levels.

The bedside monitor, with an alarm that alerts the caregiver to blood glucose changes, helps protect against low blood sugar episodes, which can lead to seizures or even coma or death. Parents and other caregivers can see a child’s or adult’s glucose trends and insulin pump information on the device, called the mySentry Remote Glucose Monitor, and can take action to prevent a further decline in blood sugar if needed or remain in bed if all is well.

Britta Bushnell, whose 11-year-old son Kaden Kessel was diagnosed with type 1 diabetes when he was 2, is used to getting up during the night to check her child’s blood sugar. She believes having a monitor could have prevented two low-glucose episodes that caused Kaden to temporarily lose the use of his limbs and ability to speak.

The suburban Los Angeles mother received a monitor last summer as part of Medtronic’s evaluation process for the device.

“It gives a peace of mind at night that is just very difficult to have any other way,” Bushnell said in an interview.

When Kaden is older, the monitor will be placed beside his bed where it will wake him when he is ready to take care of his own insulin needs. “This puts college in a whole new light for me,” Bushnell said.

The mySentry monitor, which costs about $3,000, works with Medtronic’s MiniMed Paradigm Real-Time Revel System, an insulin pump with built-in continuous glucose monitoring. In addition to displaying blood sugar readings, the device provides information on the insulin pump battery life and amount of insulin remaining.

About 3 million Americans have type 1 diabetes, a disease in which the immune system destroys cells in the pancreas that make insulin. Patients must monitor their blood sugar and inject themselves with insulin throughout the day to prevent potential complications such as blindness, heart disease and kidney disease.

Medtronic, a leading maker of insulin pumps and continuous glucose monitors, is among the companies and researchers working to develop an artificial pancreas system that ultimately would provide insulin dosing automatically.

The company’s most advanced insulin pump, the Paradigm Veo, includes an automated safety feature called low-glucose suspend that shuts off the insulin flow when glucose falls low. The device, connected to patients through a small catheter placed just under the skin, is sold in 50 countries outside the United States.

Medtronic recently received approval to begin a U.S. clinical study for the device that will enroll a minimum of 285 patients at 20 U.S. sites. The company hopes to be able to sell the product in the United States in about 2-1/2 years, Greg Meehan, general manager of Medtronic’s continuous glucose monitoring business, said in an interview.

Medtronic is also looking to develop monitoring technology that can one day work with consumer devices including mobile phones, Meehan said.

“This is the first step in what we think is going to be a significant innovation category for diabetes care in the future,” he said.

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By Susan Kelly

CHICAGO