Medtronic's 24-hour Diabetes Monitors Better Than Finger-Stick in Study

Medtronic Inc.’s device enabling diabetics to continuously monitor their blood-sugar levels was almost three times as effective as standard therapy at controlling their glucose in a study. Children also benefited.

Researchers followed 485 people with Type 1 diabetes for a year in the largest study to date, finding the Medtronic system achieved recommended blood-glucose levels in 28 percent of adults compared with 10 percent using conventional methods, according to research presented today at an American Diabetes Association meeting in Orlando, Florida. The study, also published in the New England Journal of Medicine, compared patients on the Medtronic device with those who used standard finger-stick monitors and multiple daily injections of insulin to manage their blood sugar.

The Medtronic system is only part way to the goal of an “artificial pancreas” that doctors envision: a computer- controlled device to monitor glucose continuously and release insulin without any patient effort. Still, the results of today’s industry-funded study may help drive sales gains of diabetes devices for Minneapolis-based Medtronic, said Michael Weinstein, a New York-based analyst with JPMorgan Chase & Co.

“If you can keep blood sugar in the kind of ranges we achieved in this study, you are going to reduce to a significant degree the blindness, kidney and heart disease, and other complications in these patients five, 10 or 20 years later,” Richard Bergenstal, a diabetes researcher at Park Nicollet Health Services in Minneapolis and the study’s lead author, said in an interview.

Medtronic Shares

Medtronic declined 66 cents, or 1.8 percent, to $36.21 at 4 p.m. in New York Stock Exchange composite trading. The shares have dropped 18 percent this year.

Nearly 24 million Americans have been diagnosed with diabetes, with as many as 10 percent of those having the form known as Type 1, where the body doesn’t produce the insulin needed to regulate blood sugar. The disease contributed to nearly 234,000 deaths in 2005, according to the Centers for Disease Control and Prevention.

Early, semi-automated versions of a computer-driven artificial pancreas may reach the market in four years, said Aaron Kowalski, an assistant vice president with the Juvenile Diabetes Research Foundation International, a New York-based advocacy group. Getting a fully automated artificial organ to market may take a decade, he said.

‘Clear Leader’

Medtronic is “the clear leader” in the competition to develop an automated system for insulin delivery, JPMorgan’s Weinstein said. Last September, Medtronic began marketing in Europe its most advanced diabetes device. Known as Paradigm Veo, the device can automatically halt insulin delivery from a pump when sensors detect that a patient’s blood sugar has fallen below safe levels. Severe low blood sugar, or hypoglycemia, is a dangerous condition that may cause loss of consciousness, seizures, comas or even death.

Medtronic’s MiniMed Paradigm system used in the study combines a glucose monitor, a hair-thin wire inserted just beneath the skin and a tiny transmitter that sends blood-sugar readings to a mobile phone-size insulin pump that is worn on the body. The monitor provides glucose readings about every five minutes to the pump, which delivers insulin through a small soft tube and a needle stick. The pump can graph blood sugar trends, allowing the patient to adjust their insulin levels.

The U.S. market for continuous glucose monitors may reach as much as $4 billion if half of the nation’s insulin-dependent diabetics used the devices, John Putnam, an analyst with Capstone Investments Inc. in Milwaukee, Wisconsin, wrote in a June 15 note to investors.

Sales Effect

The Medtronic study, known as Star 3, “is potentially significant to the company’s diabetes franchise and its efforts to drive the integration of their sensors with the pumps,” Michael Weinstein, a New York-based analyst with JPMorgan Chase & Co. said in June 17 interview.

In the study, researchers tracked 329 adults and 156 children ages 7 and older whose Type 1 diabetes wasn’t well controlled. Among children ages 7 to 18, 44 percent who wore the monitors achieved blood-sugar recommendations, compared with 20 percent of those on standard therapy, according to the study.

Previous research found children didn’t benefit significantly from the continuous monitors, partly because they were less likely to wear the devices, said Bergenstal, executive director of Park Nicollet’s International Diabetes Center.

“Now we’ve been able to show these children, adolescents and adults get about the same benefit,” he said.

Demands on Patients

The study demonstrates the benefits of continuous blood- sugar monitors, though some gains may be offset by technology that demands more of patients, said Howard Wolpert, a researcher at the Harvard-affiliated Joslin Diabetes Center in Boston.

“The expert guidance received by patients in clinical trials cannot be readily duplicated in a busy clinical practice,” Wolpert wrote in an editorial that accompanied the journal article. For some patients, “the complex task of inserting and calibrating the sensor, troubleshooting device malfunctions and responding to alarms can become a burden that detracts from the benefits of the technology,” he said.

Diabetes products contributed $1.2 billion, or nearly 8 percent, of Medtronic’s revenue last year. Sales of Medtronic’s glucose monitors grew 47 percent in 2009 from a year earlier, according to a Medtronic presentation at a June 7 analyst meeting in New York. The company doesn’t break out specific sales figures for the monitors.

Regulatory Approval

Medtronic’s glucose monitoring system won U.S. approval in 2006. The system is used for patients with Type 1 form of the disease and Type 2 patients who require insulin, said Amanda Sheldon, a Medtronic spokeswoman.

Type 2 diabetes, which accounts for about 90 percent of cases, is most common in people ages 40 and older. It is linked to obesity, physical inactivity and a family history of the illness, according to the CDC. Diet, exercise, weight loss and oral medications are the recommend treatments for most, though some type 2 patients must give themselves regular insulin shots.

About 3 million to 4 million people with Type 2 diabetes who take insulin are also potential users of the glucose monitoring systems, said Francine Kaufman, vice president of global medical affairs with Medtronic’s diabetes unit.

Medtronic is competing with other makers of insulin pumps or round-the-clock glucose monitors including San Diego-based DexCom Inc., Bedford, Massachusetts-based Insulet Corp., Abbott Park, Illinois-based Abbott Laboratories and New Brunswick, New Jersey-based Johnson & Johnson.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net