Clinical assessment of the accuracy of blood glucose measurement devices

Abstract

This study demonstrated the very high accuracy of BG*Star, iBG*Star, and the competitive blood glucose meters in a clinical setting.

Determination of Hematocrit Interference in Blood Samples Derived from Patients with Different Blood Glucose Concentrations

“…14 The results of this accuracy study are published elsewhere. 15 The responsible ethical review board approved the clinical accuracy study and the HCT interference sub-study and the participants gave written informed consent prior to any study procedure. Patients were required to be between 18 and 65 years of age, had to be healthy or have type 1 or type 2 diabetes mellitus.…”

A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range

“…[13][14][15] A direct comparison of the BGStar system accuracy evaluated by the clamp method and a reduced scale protocol of the ISO 15197:2013 guideline showed good agreement between both test procedures with MARD within 0.8% from another and both methods identified a similar amount of outliers, typically in the range of 1-2% for the standard 15/15 limits of ISO15197:2013 and 9-10% for more restrictive 10/10 limits. 16 These comparisons indicate that the glucose clamp approach can provide robust and valuable data about the accuracy of BG system performance.…”

Considerations for an Institution for Evaluation of Diabetes Technology Devices to Improve Their Quality in the European Union

“…In the past, some manufacturers have financed the performance of such studies. [2][3][4] The published results present a very different picture of a wide range of measurement quality for tested BG systems [device with tested strip lot(s)]. The performance ranges from excellent (BG system will also fulfill the new requirements of the draft EN ISO DIS 15197:2011, i.e., system has a measurement error <15 mg/dl below 100 mg/dl and <15% above) to average (accuracy is within the requirements of the present standard EN ISO 15197:2003, <15 mg/dl below 75 mg/dl and <20% above) to a considerable number of systems with poor measurement quality (accuracy does not meet the requirements of the present ISO standard).…”