Are All Home-Based Blood Sugar Tests Equal?
FDA takes steps to eliminate potential risks for people with diabetes
By Serena Gordon
FRIDAY, March 7, 2014 (HealthDay News) -- Every day, millions of people with diabetes -- both type 1 and type 2 -- rely on the results they get from their blood glucose meters to guide their treatment decisions. But, what if those test results were wrong?
Recent research has found that even though a blood glucose monitor meets the U.S. Food and Drug Administration's standards for accuracy to gain device approval, the meter or test strips used in the meter may not perform as well as expected in the real world. And, those errors can have potentially life-threatening consequences.
"The availability of accurate blood glucose meters and test strips is critical to the success of diabetes self-management," according to a statement from the American Diabetes Association. "Faulty or inaccurate equipment can not only lead to just poor diabetes self-management, but to an acute medical crisis if a patient makes incorrect treatment decisions based on faulty data."
Current standards, which were approved in 2003, require that measurements be within 20 percent -- either over or under -- of a comparable laboratory test if the blood sugar level is currently above 75 milligrams per deciliter (mg/dL). If blood sugar levels are below 75 mg/dL, the FDA's standard for approval is that the device and strips must be within 15 mg/dL of comparable lab test results, according to Courtney Lias, director of the division of chemistry and toxicology devices at the FDA.
"We weren't really happy with the 20 percent in 2003 but hoped it would improve over time, and we hoped that market pressure would push manufacturers to improve accuracy, but many focused more on adding features," Lias said.
"We've started to talk again about why accuracy standards haven't become better, and now manufacturers are moving toward more accuracy," she said. "Most are moving to meet 15 percent for over 100 mg/dL."
A draft guidance document was released in January by the FDA asking manufacturers to meet the 15 percent goal for 95 percent of blood sugar readings, with the exception of very low blood sugar readings. The guidance document tells manufacturers what the FDA expects of them to gain approval. A draft of the guidance document will be available for several months to allow for public comment before the final document is produced.
However, the accuracy goal refers to numbers achieved prior to device approval. Once the machines and test strips are on the market, Lias noted, the FDA relies on after-market complaints to the manufacturer, which are supposed to be shared with the FDA, as well as complaints sent directly to the FDA, outreach to the clinical community and FDA inspections.
Some of that feedback to the FDA may be coming from a new campaign, called Strip Safely, started by Bennet Dunlap, a father with two teenagers with type 1 diabetes.