18 March 2010

FDA eyes improvements for diabetics' glucose devices

U.S. health regulators are taking a closer look at how well devices used by diabetics to monitor their blood sugars work, seeking possible changes for device makers to help make them more reliable.

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GAITHERSBURG, Maryland (Reuters) - U.S. health regulators are taking a closer look at how well devices used by diabetics to monitor their blood sugars work, seeking possible changes for device makers to help make them more reliable.

At a two-day meeting to review blood glucose meters, Food and Drug Administration officials and staff pointed to a number of issues that can prevent people from getting proper treatment and sought input from medical experts and industry on ways to improve test results with the widely used devices.

The FDA gets about 12,000 reports of errors with such meters each year and is currently weighing new industry guidelines, said Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health.Such errors are likely underreported, but must be weighed against the billions of glucose tests done annually as patients test their sugars several times a day, other FDA staff noted.

"The importance of blood glucose meters in the management and control of diabetes is unquestionable," Shuren said."Some in the clinical and patient communities... have challenged FDA to require tighter performance standards," he said, while "Others believe... that there is no evidence to support the need for higher standards.Companies such as Roche, Bayer and others make blood glucose meters used by diabetics on their own or by healthcare providers at doctors' offices or hospitals to monitor patients. They are not currently FDA-approved to screen for diabetes although they are used to do so.The devices, which have been around for more than 30 years, use small blood samples to check sugar levels in the blood.

If levels are too low, patients may then need to eat something or, depending on their condition, may need insulin.Accurate readings are key to prevent overtreating or undertreating patients, experts told the FDA. Otherwise, patients can experience sugar levels that are too high or too low and experience complications such as confusion and weakness. Over time, overall improper blood sugar control in diabetics can lead to more serious problems such as ulcers, amputation and even death.

At issue is whether incorrect meter readings stem from problems with the technology or other issues such as patients or doctors and nurses not using the devices properly. Other problems can include trouble with test strips, blood samples, hand washing and other factors that can impact results.The concerns are particularly important as the number of Americans with diabetes grows. Roughly 24 million people in the United States have the condition -- a figure largely expected to double by 2025.The devices also "have migrated" to wider use in hospitals' intensive care units even though they are not intended for such critical care use, said Courtney Harper, the head of the FDA's office that oversees glucose and other testing devices.

Devicemakers said they support changes to improve meter readings.The industry's current standard calls for devices used by patients to be accurate within 20 percent, but companies back changes to tighten that to within 15 percent. Standards should also be set for devices used by doctors and nurses, an industry representative said.Still, the industry lauded changes over the years that have made monitors easier and more convenient to use, adding that consistent monitoring helps prevent costly complications from diabetes.

"Today's meters can fit into a patient's pockets... are virtually pain free, and can produce data in as little as five seconds," said Steve Brotman, a senior vice president at the industry group Advanced Medical Technology Association.David Sacks, a pathologist and internal medicine physician at Harvard Medical School, agreed the current standard "is inadequate" and pushed officials to adopt a 10 percent margin of error. A 5 percent range would be even better but is impossible given current technology, he added.Other experts said more attention must be paid to how medical professionals use the devices, since some studies show that patients who constantly test themselves tend to have fewer error rates.

Additionally, "how much accuracy you need depends on who you are," said industry consultant Barry Ginsberg. Those with type 2 diabetes who treat their condition with diet changes and oral drugs don't need to monitor their blood levels as closely as those with type 1 diabetes who take insulin, he said.Simple steps like better handwashing, patient education and clearer device labels could also reduce errors, experts said.The FDA on Wednesday will continue its public meeting, focusing on use of the meters in hospitals.


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