The Food and Drug Administration may soon require glucose monitors to become more accurate, according to a New York Times report.
The FDA has traditionally followed international standards, which have, unbelievably, allowed the monitors to provide blood sugar readerings that are off by as much as 20%. However, with the rise in the disease and more than 11 million diabetics in the U.S. using monitors at home and in hospitals, the agency may be forced to make changes to its standards.
False readings can lead diabetics to make uninformed choices about how much insulin to take. The F.D.A says that it receives reports of thousands of injuries and several deaths each year relating to problems with glucose monitors. However, experts suggest that the cases are underreported and that 40% of diabetics that take insulin will become comatose or suffer seizures at some point during their life due to abnormally low blood sugar levels, according to the Times report.
Manufacturers say the biggest challenge to improving accuracy is cost. If better monitors are required, they will cost more, and therefore less people are likely to use them.
The 16-year old daughter of an aide to Senator Charles Grassley, a Republican from Iowa, conducted a study that showed monitor results can vary by as much as 32%. The Senator was alerted to the results and sent a letter to the F.D.A.
The monitor companies quotes in the Times article say they are content with current standards, but will adhere to any changes the F.D.A requires.
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