(HealthDay News) — The accuracy of blood glucose meters in the low glycemic range is questionable, according to an observation letter published in Diabetes Care.
Noting that the U.S. Food and Drug Administration (FDA) draft guidance for over-the-counter blood glucose meters requires at least 95% of results within ±15% and at least 99% of results within ±20% across the whole glycemic range, Lutz Heinemann, PhD, from Science & Co. in Düsseldorf, Germany, and colleagues examined whether current blood glucose meters fulfill these criteria.
The authors also queried the use of predefined hypoglycemia thresholds when a blood glucose meter cannot reliably differentiate between 50 mg/dL, 60 mg/dL and 70 mg/dL.
The authors note that these questions are relevant from a safety perspective when patients with diabetes measure their blood glucose concentration, and are important when blood glucose meters are used in clinical trials.
In assessments of current blood glucose meters, considerable differences were seen in performance in the low glucose range. This may explain why the FDA does not accept blood glucose measurement data as evidence for the efficacy of antidiabetic drugs with regard to hypoglycemia reduction.
This raises the question of whether blood glucose meters can be used in clinical trials that aim to show a benefit in terms of hypoglycemia risk.
“We wonder whether, from a clinical point of view, greater interest should be displayed in the performance of [blood glucose meters] in the low glycemic range,” the authors wrote.
Several authors disclosed financial ties to the pharmaceutical and medical device industries.