Suboptimal Performance of Blood Glucose Meters in an Antenatal Diabetes Clinic

Abstract

OBJECTIVEThe objective of this study was to evaluate the performance of blood glucose meters in diabetes associated with pregnancy (DP).RESEARCH DESIGN AND METHODSFinger-prick blood glucose levels measured using six different glucose meters on 102 patients with DP attending an antenatal clinic were compared with laboratory plasma glucose results. HbA1c and hematocrit were also measured.RESULTSThe plasma glucose range was 2.2–9.4 mmol/L with hematocrit 33–37% and mean HbA1c 5.5% ± 0.56 (SD). All meters provided plasma equivalent results except one, which reported whole blood glucose that was adjusted to plasma equivalent values. The absolute glucose difference [meter − plasma glucose] was 0.232 ± 0.69 to 0.725 ± 0.62 mmol/L mean ± SD and bias ranged from 6.1 to 15.8%. Two meters were affected by hematocrit <36% (P < 0.05).CONCLUSIONSBlood glucose meters in current use are not optimally accurate when compared with plasma glucose measurement in DP. Recognition of this deviation is essential to prevent inappropriate treatment of DP.

A Perspective on the Accuracy of Blood Glucose Meters During Pregnancy

“…The Roche Accu-Chek Active glucose meter exhibited the lowest mean bias and thus demonstrated the best analytical accuracy. With the exception of one study (14), most glucose meters had a large proportion (.98-99%) of the meter values in zones A and B of the error grid analysis, which led to clinically appropriate treatment. Three devices (Optium, Optium Xceed 20s, and Optium Xceed 5s) showed a discrepancy from the reference values with a change in the maternal hematocrit level that rendered them unsuitable for use during pregnancy.…”

“…A literature search identified 355 articles, of which only a few were relevant to the review objective. Four studies (11)(12)(13)(14) met the eligibility criteria and were selected for the review. A total of 10 different glucose meter devices manufactured by 5 different companies were reviewed, 2 of which were available in the U.S.…”

Evaluating the utility of a point‐of‐care glucometer for the diagnosis of gestational diabetes

“…Venous blood was drawn by a trained research nurse into a fluoridated tube and was stored on ice until delivery to the laboratory as soon as possible, simulating the real clinical situation. The sample was centrifuged on arrival at the laboratory, unlike other studies in which it was centrifuged within 5–30 minutes . The laboratory is accredited by the South African National Accreditation System, and uses the Beckman DXc hexokinase method to measure glucose.…”

Blood Glucose Measurements in Critically Ill Patients

“…When considering only the bias and the imprecision, total error can be computed with the Westgard equation (% total error = % average bias + 1.96 * coefficient of variation) as used in a study on the performance of BG meters in the context of diabetes during pregnancy. 28 Another known technique to approach total error was developed by Bland and Altman. [29][30][31] In this graphical method, the differences of the paired measurements are plotted against the average of the two values.…”