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Study urges steps to fast-track new diabetes monitor

Devices to continuously monitor the blood-sugar levels of diabetes patients are still largely in research labs, but the New England Healthcare Institute says it's high time to figure out how to get the machines approved by regulators and paid for by insurance companies.

In a study to be released today, the institute, a nonprofit health policy organization focused on enabling innovation in healthcare, said such devices will dramatically improve the health of diabetic patients. To speed early adoption of the glucose-monitoring devices, advocates and regulators need to establish accuracy standards so they don't get bogged down in evaluations by the US Food and Drug Administration.

''Our study shows that this is a highly cost-effective and valuable technology," said Valerie Fleishman, vice president of the institute. ''It has the ability to dramatically improve the lives of millions of diabetes patients. Our overview of the technology for the next three to five years highlights the barriers that could impede adoption of this technology."

Continuous glucose monitors have the potential to dramatically change daily life for many of the roughly 18 million Americans with diabetes. Many patients have to monitor their blood-sugar levels several times a day, pricking their fingers to get a drop of blood to put on a test strip. Some patients aren't conscientious about monitoring.

''While it says on the finger-stick testing supply boxes that they're painless, trust me, they're not," said Dr. Aaron Kowalski, scientific program manager for the Juvenile Diabetes Research Foundation, an advocacy group that funds research. ''They hurt, and most people with diabetes are kids."

More important, the continuous monitors provide more detailed information. Instead of a single snapshot of blood-sugar levels, continuous monitoring can show whether glucose is rising or falling, and how quickly. That can have a big impact on how patients dose themselves with insulin to manage the glucose level.

Keeping glucose within certain boundaries prevents low-blood-sugar episodes that can cause blackouts, and it eliminates periods of high blood sugar, which are linked to the development of serious complications such as blindness, loss of circulation, kidney failure, and heart disease.

''This tool will allow people to control their blood sugar more tightly and will reduce their risk for complications," said Dr. Howard Wolpert, director of the insulin pump program at the Joslin Diabetes Center in Boston.

While there are continuous glucose monitors that doctors use in their offices, several firms are rushing to develop a home version for patients. Medtronic Inc. of Minneapolis sells a system for about $2,000 that patients, under the supervision of a physician, can wear for up to three days. It measures glucose levels every five minutes with a sensor placed under the skin. The firm's next device, intended for patients, would monitor glucose continuously and sound an alarm if it falls outside a set range.

Another Medtronic device, scheduled to begin testing this summer, would combine glucose monitoring with an insulin pump, moving closer to the automatic glucose management provided by the pancreas in healthy people.

Sontra Medical Corp. of Franklin is developing its own device in conjunction with Bayer AG, the German drug giant. Sontra's approach uses one device to create micropores in a patient's skin. Then a second device is attached to the permeable area, providing glucose readings for up to 24 hours. The firm predicts it may be ready for the home market by 2008.

In healthy patients, cells in the pancreas respond to the glucose level in the blood and secrete insulin as necessary. For unknown reasons, these cells are destroyed in patients with Type 1 diabetes. They must inject insulin, a hormone, to regulate their blood sugar. In Type 2 diabetes, a person gradually loses the ability to manufacture insulin or use it efficiently, leading to complications from improper blood-sugar levels.

The health institute study highlights other factors that could slow the adoption of continuous monitoring devices. In order to get insurance companies to pay for the devices, manufacturers will have to demonstrate their value compared to traditional finger-stick methods. But there is no consensus on how to demonstrate long-term benefits. One problem is the serious complications that often come with diabetes develop over many years.

The study also urges the FDA to establish new accuracy standards to judge the coming generation of machines. In addition, the institute said the FDA hasn't developed labeling to show that a continuous monitoring device is an approved replacement for standard finger-stick monitoring. Both steps could speed adoption of the new devices when they become available, the institute said.

Jeffrey Krasner can be reached at krasner@globe.com.

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