Are All Home-Based Blood Sugar Tests Equal?
FDA takes steps to eliminate potential risks for people with diabetes
"I was pretty frustrated when I heard that there were blood glucose monitoring systems (devices and test strips) that failed to even meet the 20 percent standard," Dunlap said. In response, he created the Strip Safely campaign to "try to create a call to action for the FDA by the diabetes community."
Dunlap said he wants to be sure that the FDA uses its power to recall faulty diabetes equipment in much the same way that it polices other products.
"The FDA recently recalled cilantro because it contained a risk of 'serious or potentially fatal infections,' according to their press release," he said. "Well, faulty test strips can cause serious and potentially fatal injections [of insulin] in people with diabetes."
The most serious risk from a faulty blood sugar test is that someone with type 1 diabetes (an autoimmune disorder that always requires insulin treatment) or someone with type 2 diabetes who uses insulin could give themselves too little or too much insulin. The most immediate danger would be from too much insulin, which can cause hypoglycemia, or low blood sugar levels. Hypoglycemia causes troubling symptoms, such as shakiness, sweating and confusion, and if left untreated, can cause someone to pass out or even die. Too little insulin results in hyperglycemia, or high blood sugar. Over time, hyperglycemia can lead to such complications as kidney disease and vision problems.
Dr. David Simmons is chief medical officer of Bayer HealthCare's Diabetes Care, in Tarrytown, N.Y. He said: "People should understand that every time you do a blood sugar test, it's an experiment, and the results have a range. Even tests done in a lab have ranges. Bayer takes accuracy standards very seriously and aimed for a substantial improvement in our new line of meters." He said that 99 to 100 percent of Bayer's new meters meet the 20 percent guideline and about 98 percent meet the 15 percent guideline.
Another manufacturer, Abbott Diabetes Care in Alameda, Calif., "makes substantial investments to monitor and control manufacturing variability," said Jared Watkin, head of technical operations for Abbott. The company has "strict controls in place to ensure consistent quality within each lot and from lot to lot," he said. "Managing diabetes depends on having an accurate understanding of blood glucose levels, so strip accuracy is critical."
Both company spokesmen said they would welcome third party, independent, after-market assessments of their products, which is something that's been proposed to the FDA by the Diabetes Technology Society, a nonprofit organization that focuses on the development and use of technology to fight diabetes.
Watkin said that such assessments could help level the playing field between manufacturers in the United States and those in other countries.
"Research shows that not all strip manufacturers can verify the accuracy of their strips," Watkin said. "Internal tests and third-party published trials show multiple on-market systems fail to meet the [20 percent] performance standards, and there is also evidence of inconsistent adverse event reporting. In addition, foreign-based manufacturers aren't subjected to unannounced audits by the U.S. FDA."