Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic (#284)
Background: Accurate assessment of blood glucose levels in women with hyperglycaemia in pregnancy is necessary to guide clinical management decisions, in order to minimise adverse outcomes for both mother and neonate. Self-monitoring of blood glucose using a blood glucose meter is the most common method used to determine whether treatment targets are being achieved, however the accuracy of blood glucose meters in pregnancy is unclear.
Methods: Pregnant women with gestational, type 1 or type 2 diabetes had capillary blood glucose levels measured in duplicate using the BGStar (Sanofi, Australia) and FreeStyle Lite (Abbott, Australia) blood glucose meters. Venous blood samples were collected and analysed for plasma glucose, haematocrit and HbA1c. Capillary blood glucose was compared to plasma glucose and further assessed according to ISO-15197:2013 standards. Bland-Altman analysis was performed to evaluate agreement between the blood glucose meter and laboratory plasma glucose results. Clarke Error Grids were used to assess the clinical impact of blood glucose meter deviations from the true blood glucose value.
Results: 110 women were recruited over an 8 month period, providing 96 samples suitable for analysis. The mean (± SD) laboratory plasma glucose level was 4.6 ± 1.4mmol/L; the BGStar and FreeStyle Lite capillary blood glucose values were 5.3 ± 1.4mmol/L and 5.0 ± 1.3mmol/L, respectively. Both meters demonstrated a positive bias; 0.65mmol/L for the BGStar and 0.42mmol/L for the FreeStyle Lite. Neither meter fulfilled ISO-15197:2013 standards and both meters demonstrated slightly better performance at blood glucose levels ≤ 4.2mmol/L. Haematocrit did not affect the results of either blood glucose meter. In addition, Clarke Error Grid analysis demonstrated that ~80% of the results of both meters would lead to appropriate clinical action.
Conclusions: In this study, neither the BGStar nor the FreeStyle Lite blood glucose meters met the latest ISO recommendations for blood glucose monitoring systems and tended to overestimate blood glucose values when assessed in a population of women with diabetes in pregnancy. Healthcare professionals should be aware of these findings when using these meters to guide decisions related to management of hyperglycaemia in pregnancy.