Diabetologie und Stoffwechsel 2011; 6 - P286
DOI: 10.1055/s-0031-1280953

Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: A European multi-centre study with 453 subjects

C Tack 1, H Pohlmeier 2, T Behnke 3, M Grenningloh 4, T Forst 5, A Pfützner 5
  • 1Radboud University Nijmegen Medical Centre, Department of Medicine, Nijmegen, Netherlands
  • 2Zentrum für Diabetes und Gefäßerkrankungen, Münster, Germany
  • 3Diabeteszentrum, Neuwied, Germany
  • 4IKFE-CRO, Mainz, Germany
  • 5IKFE – Institut für klinische Forschung und Entwicklung, Mainz, Germany

Background and aims: This multi-centre study was conducted to evaluate the performance of five of the most recently introduced blood glucose monitoring systems (BGMS; Accu-Chek® Aviva, CONTOUR®, FreeStyle Freedom Lite®, FreeStyle Lite®, and OneTouch® UltraEasy®) under daily routine conditions. All devices and strips were obtained independently from the manufacturers directly from a German pharmacy.

Method: Subjects with Type 1 (49%) and Type 2 diabetes aged 18 to 75 years, and attending a diabetes outpatient clinic, were enrolled in the study. Subjects were randomised to receive three of the five BGMS. They were asked to study the instruction manuals and to perform a blood glucose test (in duplicate) with each system. A YSI 2300 Stat Plus Glucose Analyser served as the comparative reference method in the study. The YSI whole blood glucose results were converted to plasma equivalent results and these results were used as comparator to the test strip results. The primary study endpoint was mean absolute relative difference (MARD).

Results: FreeStyle Lite (n=240 subjects) showed similar results to FreeStyle Freedom Lite (n=244) and significantly better accuracy performance than Accu-Chek Aviva (n=252), Contour (n=252) and OneTouch UltraEasy (n=246) in terms of MARD and other parameters (MARD: 4.9% vs. 5.5%, 6.8%, 9.0% and 9.7%: n.s., p<0.001, p<0.0001 and p<0.0001, respectively; %CV: 2,5% vs. 3,1%, 2,9%, 5.1%, and 4.5%; % within +- 15mg: 98% vs. 95%, 94%, 86%, and 83%). Four adverse events occurred during this study, all for mild hypoglycaemia not related to the study device.

Discussion and conclusion: MARD is a measure of system accuracy and precision, it correlates well with Clarke Error Grid Zone A performance and % within±15mg/dL/±20%. MARD is a continuous measure that uses the magnitude of the relative difference for each observation. In contrast; Clarke Error Grid Zone A performance and % within±15mg/dL/±20% use only whether the results are within or beyond a limit, but otherwise ignoring the magnitude of the results.The results from this study show that of the five BGMS evaluated, the FreeStyle Lite showed significantly better accuracy performance than Accu-Chek Aviva, Contour and OneTouch UltraEasy systems in a routine setting.