Are All Home-based Blood Sugar Tests Equal? 2

Are All Home-based Blood Sugar Tests Equal?

Recent research has discovered that even though a blood sugar monitor meets the U.S. Food and Drug Administration’s criteria for accuracy to gain device authorization, the meter or test strips found in the meter may not perform as well as expected in real life. And, those errors can have life-threatening implications possibly. Current standards, that have been approved in 2003, require that measurements be within 20 percent-either over or under-or a comparable laboratory test if the blood sugar level happens to be above 75 milligrams per deciliter (mg/dL).

A draft guidance document premiered in January by the FDA asking manufacturers to meet up with the 15 percent goal for 95 percent of bloodstream sugar readings, apart from very low bloodstream glucose readings. The guidance record tells manufacturers the actual FDA expects of these to gain approval. A draft of the assistance document will be available for several months to permit for public comment before the final record is produced. However, the accuracy goal identifies quantities achieved to device authorization prior.

Some of that feedback to the FDA may be coming from a new campaign, called Strip Safely, started by Bennet Dunlap, a paternalfather with two teenagers with type 1 diabetes. Dunlap said he wants to make certain that the FDA uses its capacity to recall faulty diabetes equipment in a quite similar way that it polices other products.

Dr. David Simmons is the main medical official of Bayer HealthCare’s Diabetes Care, in Tarrytown, N.Y. Another manufacturer, Abbott Diabetes Care in Alameda, Calif., “makes substantial investments to monitor and control manufacturing variability,” said Jared Watkins, head of technical functions for Abbott. The company has “strict controls in place to ensure consistent quality within each lot and from the great deals to a lot,” he said.

Watkin said that such assessments could help level the taking part in field between manufacturers in the United States and those in other countries. The FDA’s draft assistance document addressed this by requesting manufacturers to describe their accuracy on the labels. Concerns, however, prolong beyond standards and manufacturers. Watkin said. That program, which began last summer, lowers the expense of blood-testing materials, but limits where people can go to get them.

Dunlap also expressed some get worried about people’s insufficient control over which product they choose and insufficient information to make the right choice. However, people with diabetes “should continue to ensure that you rely on test strips,” the FDA’s Lias said. Dunlap urged people to go one step further: If you have experienced a problem with a blood sugar meter or a test to remove, make sure to survey it both to the maker and the FDA. For some useful tips on monitoring your blood glucose, read this HealthDay tale.

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