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FDA Approves
Insulin Device
For Diabetics

The Food and Drug Administration approved a combination insulin pump and glucose monitor system, offering a way for some Type 1 diabetes patients to avoid dangerous episodes of hypoglycemia, or low blood sugar, and reduce their risk of a host of complications and death.

The Paradigm system, created by Medtronic Inc., of Minneapolis, includes a monitor taped to a patient's abdomen that continuously reads his or her blood glucose and transmits the data to a pump, which beeps or vibrates when blood sugar drops to a dangerous level. Patients adjust the pump, worn like a pager, to administer insulin into a port in the body. The system eliminates the need for repeated needle sticks to test blood and to inject insulin.

The Paradigm blood monitor-insulin pump, created by Medtronic's MiniMed unit.

Shifting blood-sugar levels represent a potentially lethal roller coaster for patients with Type 1 diabetes, who make up about two million of the estimated 20 million people in the U.S. with diabetes. Hypoglycemia spells themselves represent an immediate and potentially lethal threat, especially if a patient loses consciousness while driving or while alone. Failing to maintain desirable levels over a period of years can lead to heart attack, stroke, kidney failure, blindness and a host of other maladies.

"This step is the dawn of a new era in diabetes care," says Aaron J. Kowalski, the Juvenile Diabetes Research Foundation's director of strategic research projects.

Using needles to test and administer insulin is an inexact science. With needle stick tests, patients get a blood-sugar reading, but no clue as to whether the level is rising or falling. If a blood sugar reading is low but increasing, the patient may administer the wrong amount of insulin. Endocrinologists say continuous monitoring represents a major advance, because it gives patients their blood-sugar levels over a three-hour window.

Some say the device is a significant step toward the creation of a free-standing "artificial pancreas." Researchers at Yale University, New Haven, Conn., currently are using Medtronic technology to study an advanced system in children, in which the pump automatically adjusts the insulin output based on glucose readings.

Competitors including DexCom Inc., of San Diego; Abbott Laboratories, of North Chicago, Ill.; and Johnson & Johnson, of New Brunswick, N.J., have produced either a continuous glucose monitor or a drug pump. Medtronic's Paradigm system represents the first combined system. The FDA hasn't approved its use in children.

The new combined system will be costly, roughly $7,000 or more, and the cost could be prohibitive, even for the insured. Insurers, including the federal government and private companies, generally don't pay for continuous glucose monitors, Medtronic says.

Chris Jarvis, a 25-year-old rower with the Northeastern University crew in Boston, says he used to stop rowing every time he had a hypoglycemia spell. He has been wearing Medtronic's monitor-pump for seven months in a premarket test. "I don't have the lows I used to see," he says. "A low blood sugar can put you out of commission for 45 minutes. With the continuous monitoring system, you can set warning thresholds, so I don't hit those dangerous lows anymore."

He plans to run in the Boston Marathon on Monday with six other runners, all wearing Medtronic continuous glucose monitors.

In Type I diabetes -- which is sometimes called juvenile diabetes, because it tends to strike children and young adults -- the pancreas stops, or nearly stops, producing insulin, a hormone that regulates blood-sugar levels. In the more common Type 2 diabetes, which usually develops in adult years, patients produce some insulin, but their bodies develop resistance to it.

The Medtronic Paradigm is intended mainly for people with Type I diabetes, although doctors say patients with severe Type 2 diabetes might also benefit. The device was developed by Medtronic's MiniMed division, of Northridge, Calif., which Medtronic acquired in 2001.

John B. Buse, director of diabetes care at the University of North Carolina and vice president of the American Diabetes Association, says 24-hour-a-day blood-sugar monitoring represents a huge advance. "Personally, I have had two patients who I'm convinced died from hypoglycemia," says Dr. Buse. "Any such severe events could be fatal." Many diabetes patients with hypoglycemia exhibit symptoms such as sweating and jitters, but others can develop it without symptoms and pass out.

Louis Philipson, director of the diabetes center at the University of Chicago, says the device "is a little cumbersome." Still, he adds, "the differences between checking four to eight times a day and continuous monitoring are huge." Doctors say they hope continuous monitoring can reduce deaths.

A 1999 study in the journal Diabetes Care referred to the "dead in bed syndrome," in which young diabetic patients die in an undisturbed bed after having been in apparently good heath the day before. The study, from British and Scandinavian researchers, concluded that such cases represent 6% of all deaths in diabetic patients under 40.

"Good glycemic control is very hard, even with the best tools," says Joe Largay, a physician assistant at North Carolina and a diabetic. "This system tells you if you're on the way down and headed toward hypoglycemia in the next few minutes."

Write to Thomas M. Burton at tom.burton@wsj.com

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