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Questions raised about accuracy of meters.

WASHINGTON -- Despite the ease of use and attractive price points of blood glucose meters, concern has arisen in some diabetes care circles about the accuracy of such products, which millions of diabetes patients rely upon to regulate their blood sugar.

At a meeting of researchers analyzing studies that show wide variation in the performance of the machines used to measure blood glucose levels, Katherine Serrano, diabetes branch chief in the Food and Drug Administration's division of chemistry and toxicology devices, said the federal government is aware of accuracy problems with some meters on the market. But she said the FDA is limited in its response because some manufacturers are in Asia and that the agency must rely on the manufacturers' own studies related to accuracy.

The issue is crucial: if a blood glucose meter provides a false reading, it places a patient at risk of dosing with excessive or insufficient insulin. If too much insulin is administered, blood glucose levels could fall to dangerously low levels, putting the patient at risk of hypoglycemia and possible hospitalization.

Typically, a person with diabetes tests blood sugar before eating or exercising to learn whether it is in the normal range. The patient then uses insulin or diet to restore blood glucose to a healthy level.

"There have been a lot of advances in the technology of the meters, but we have not seen great strides in accuracy," Serrano said, adding that federal law requires only that they prove they are "substantially equivalent" to another meter already on the market. The FDA relies on the manufacturer's own studies to analyze accuracy and does not require any independent testing.

In response to such apprehensions, Roche Diabetes Care is promoting its product portfolio under the theme "Don't gamble on the accuracy of your blood glucose meter."

According to the company, "Three studies recently published in The Journal of Diabetes Science and Technology found that of 41 blood glucose meters tested, more than half failed to consistently meet the global standard for meter accuracy. Fortunately, these same studies showed that there are blood glucose meters such as the ACCU-CHEK Nano and ACCU-CHEK Aviva meters."

Roche pointed out that its meter and test strip combinations are made in the United States.

Furthermore, the company said, adults living with diabetes in the United States reported highest satisfaction using ACCU-CHEK products compared with other blood glucose meter manufacturers, according to the inaugural J.D. Power and Associates 2012 Blood Glucose Meter Satisfaction Study.

The study gathered responses from 2,681 current meter users with type 1 and type 2 diabetes in the United States to determine customer satisfaction across six factors: performance, ease of use, design, features, cost of test strips and training.

In addition to achieving the highest rating in overall satisfaction, ACCUCHEK blood glucose meters, which include the ACCU-CHEK Nano SmartView system, ACCU-CHEK Aviva Plus and ACCU-CHEK Compact Plus, scored the highest in performance, ease of use, cost of test strips and training.

"A blood glucose meter is one of the most important tools for people with diabetes, as it empowers them to independently manage their diabetes on a daily basis," said Debbie Hinnen, a diabetes educator and director of education services at Mid-America Diabetes Associates. "Therefore, a meter that is accurate and easy to use is key, as it helps to ensure patients make informed decisions about their meal plan, exercise, insulin use and other lifestyle challenges."

Also making advances this year in glucose meter technology is LifeScan Inc. In March the company's OneTouch VerioSync Blood Glucose Monitoring System received clearance from the FDA. It is described as the first meter to automatically send blood glucose results wirelessly via Bluetooth technology to an iPhone, iPad or iPod touch using the OneTouch Reveal mobile app

"For so many people, their iPhone, iPad or iPod touch have become a tool of choice to help organize and take charge of their daily lives," said Ty Lee, vice president of marketing, representing the products of LifeScan and Animas Corp.

"For people with diabetes, the new OneTouch Verio Sync System will enable them to use their iOS device to view and share their blood glucose results wirelessly, in much the same way they rely on them in other areas of their lives."

Through the mobile app, users will be able to view a variety of personalized information directly on their iPhone, iPad or iPod touch including a 14-day summary of blood sugar test results, simple visuals showing the percentage of test results within target range, and then share that information via email or text with their care providers, family or friends.

Animus, also a Johnson & Johnson company, markets the OneTouch Ping Glucose Management System and the Animas 2020 insulin pump.
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Title Annotation:RX/Diabetes Care
Publication:Chain Drug Review
Date:Sep 30, 2013
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