Cleared Blood Glucose Monitor Systems Not Always Accurate
HealthDay News — One in 3 commercially available blood glucose monitor systems (BGMs) meet a predefined accuracy standard, according to research published online June 13 in Diabetes Care.
David C. Klonoff, MD, from the Diabetes Research Institute in San Mateo, California, and colleagues recruited 1035 subjects to have a capillary blood glucose level measured on 6 different systems and a reference capillary sample prepared for plasma testing at a reference laboratory. The products, which were obtained from consumer outlets, were tested in three triple-blinded studies. For each of the 3 studies, each of the 3 participating clinical sites tested a different set of 6 systems. A BGM was tested on 115 subjects, on average, in each study. In each study, the proportion of compliant readings was compared against a predetermined accuracy standard, which was similar to, but more lenient than, current regulatory standards.
The researchers found that almost identical BGM rankings were produced with the different accuracy metrics. The predetermined accuracy standard was met by 6 of the 18 systems in all 3 studies, 5 systems in 2 studies, and 3 systems in 1 study. The accuracy standard was not met in any of the 3 studies by 4 BGMs.
"Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance," the authors write. "This information could assist patients, professionals, and payers in choosing products, and regulators in evaluating post-clearance performance."
Several authors disclosed ties to the pharmaceutical industry, including Abbott Diabetes Care, which funded the study.