The FDA approved a Medtronic device that sounds an alarm if glucose levels move out of a safe range.
The Food and Drug Administration has given Medtronic Inc. approval to sell a new device that lets caregivers monitor the blood sugar of people with diabetes from another room.
The device could be especially helpful for parents of children with Type I diabetes, who are up multiple times during the night checking blood sugar levels to avoid hypoglycemia, which can result in seizures, hospitalizations and, in some cases, death.
The monitor sets off an alarm if glucose levels get dangerously low or high.
"This type of technology is so important for families," said Jenni Hargraves, executive director of the American Diabetes Association of Minnesota and North Dakota. "To be able to look at something and see that your child is safe, that the blood sugar isn't low -- or high -- is pretty cool. If I were the parent of a child with diabetes, this would definitely help me sleep better at night."
The monitor, known as mySentry, works in tandem with insulin pumps and a continuous glucose monitor, two products in which Medtronic already has the dominant market share.
The monitor sits in one room, and a separate device in the diabetic person's room relays information wirelessly. A loud alarm can be set to go off 30 minutes before blood sugar drops too low, giving patients time to drink juice or take other action to try to ward off trouble.
Medtronic said mySentry is the first of its kind, and that the all-in-one system is not only more convenient but provides better information to manage the disease. Because blood sugar levels depend on many factors -- diet, exercise, stress levels -- it's difficult for adults and children alike to keep on top of it.
More than 1.2 million Americans have Type I diabetes, a condition in which the body doesn't produce insulin, a hormone needed to convert sugar, starches and other food into energy. It is usually diagnosed in children and young adults.
About three-fourths of episodes of hypoglycemia, or low blood sugar, occur at night. About 6 percent of deaths of Type 1 diabetics under the age of 50 are due to what is called "dead in bed syndrome," where blood sugar goes too low during the night.
Thomas Gunderson, senior health care analyst with Piper Jaffray & Co. in Minneapolis, said the remote monitor could help Medtronic expand market share. The company already is the world's top maker of pumps, and is one of only two companies in the United States to sell a continuous glucose monitor.
Gunderson said the device also could be a link to the next generation of remote caregiving.
"It's another step closer to something I've heard Medtronic and others talk about," he said. "If we can do that wirelessly, then can they go to a central computer? Can I monitor my child, my brother or my elderly parent when they're away from home?"
Jackie Crosby • 612-673-7335