Aims: To undertake a systematic review summarising the available evidence on the technical accuracy of glucose meters used during pregnancy.
Methods: We searched 4 databases (PubMed, CINAHL, Embase, and Scopus) for publications January 2007 to April 2017. Eligible studies assessed the accuracy of glucose meters for any clinical outcome, including the screening, diagnosis, or treatment of hyperglycemia in pregnancy. The percentage of meter values meeting International Organization for Standardization (ISO) criteria, error grid analyses, mean difference between meter and laboratory plasma values and hematocrit influences were reviewed.
Results: Only 4 studies have assessed the technical and clinical accuracy of glucose meters during pregnancy during the past 10 years. The accuracy of the 10 commercially available glucose meters in pregnancy showed substantial variability, with the majority showing positive bias and a few showing minimal negative bias. The mean difference between meter and laboratory plasma values varied between -0.33 and 0.725 mmol/l. The Roche Accu-Chek Active glucometer showed the lowest mean bias and the highest proportion of readings within 5% of the plasma glucose values. Of the three glucose meters evaluated for the ISO 15197: 2003 criteria, all three met the recommended targets. Most glucose meters had >95% of the meter values in Zones A and B of the error grid analysis. Three meters, Optium, Optium Xceed 20 s, and Optium Xceed 5 s, showed a deviation from laboratory plasma glucose results with a change in maternal hematocrit levels. Most meters showed good precision (coefficient of variance<5%).
Conclusions: No glucose meters were identified with a total analytical error of <5%. No studies evaluated meter performance for the recent ISO 15197: 2013 criteria in pregnancy. Measures must be directed to achieve a total error of <5% with both the bias and imprecision to be less than 2% during pregnancy.