Researchers question accuracy of blood glucose monitors at low glycemic range

Researchers are questioning the accuracy of blood glucose monitors in the low glycemic range, noting that many monitors cannot reliably differentiate between concentrations of 50, 60 and 70 mg/dL, according to a letter published recently in Diabetes Care.

Lutz Heinemann, PhD, from Science & Co. in Dusseldorf, Germany, and colleagues examined whether current over-the-counter blood glucose monitors fulfill the current guidelines from the Food and Drug Administration, which state that blood glucose monitors require greater than 95% of results within ± 15% and greater than 99% of results with ± 20% across the whole glycemic range. The International Organization for Standardization similarly states that the monitors are acceptably accurate if greater than 95% of their measurement results are within ± 15 mg/dL or ± 15% of reference results, whichever is greater.

“Thus, if a patient’s [blood glucose] true concentration is 60 mg/dL, acceptably accurate results range from 45 to 75 mg/dL according to ISO limits and from 51 to 69 mg/dL according to FDA criteria,” the researchers wrote.

The variations could suggest that predefined hypoglycemia thresholds are not useful, the researchers noted. The inaccuracies can also affect clinical trial results, the researchers wrote.

“We wonder whether, from a clinical point of view, greater interest should be displayed in the performance of [blood glucose monitors ] in the low glycemic range,” the researchers wrote. “This could also help in the documentation of benefits of novel drugs with respect to reduction in hypoglycemia risk.”

Disclosure: Heinemann reports receiving speakers’ honoraria or consulting fees from Abbott, Becton Dickinson, Dexcom, Roche Diagnostics, Sanofi and other companies. Please see the full observation letter for the other authors’ relevant financial disclosures.

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Source:

Heinemann L, et al. Diabetes Care. 2015;doi:10.2337/dc15-0817