A story in the New York Times this month reported that the FDA, under Commissioner Hamburg, is pressuring the international group that sets standards (International Organization for Standardization: IOS) to tighten allowable errors for in-home blood glucose monitors.If the IOS fails to act, the FDA may change the standards for meters in the US.
Self-monitoring of blood glucose devices (SMBG devices) are currently allowed to be inaccurate by up to 20%. However:
"A study by government researchers found that when comparing tests from five different popular monitors, results varied by as much as 32 percent.An inaccuracy of 75 mg/dl is not trivial.
For a class science project recently, Morgan DiSanto-Ranney, 16, of Bishop O’Connell High School in Arlington, Va., bought seven different glucose monitors and had her father, a diabetic, use all of them.
“What I found was that almost all of the meters were off from one another by 60 to 75 points,” Morgan said in an interview. Two of the meters — Ascensia Breeze and Ascensia Breeze II, both made by Bayer — differed by an average of 62 points, she said."
