A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range. (November 2016)

• Record Type: Journal Article
• Authors: Zijlstra, Eric; Heinemann, Lutz; Fischer, Annelie; Kapitza, Christoph
• Is Part Of: Journal of diabetes science and technology. Volume 10:Number 6(2016:Nov.)
• Page Start: 1316
• Page End: 1323
• Publication Date: 2016-11
• Subjects: accuracy -- blood glucose self-monitoring -- glucose clamp -- glucose meters; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296816668373
• Languages: English
• ISSNs: 1932-2968

Abstract

Background: The objective was to evaluate the performance (in terms of accuracy, precision, and trueness) of 5 CE-certified and commercially available blood glucose (BG) systems (meters plus test strips) using an innovative clinical-experimental study design with a 3-step glucose clamp approach and frequent capillary BG measurements. Methods: Sixteen subjects with type 1 diabetes participated in this open label, single center trial. BG was clamped at 3 levels for 60 minutes each: 60-100-200 mg/dL. Medical staff performed regular finger pricks (up to 10 per BG level) to obtain capillary blood samples for paired BG measurements with the 5 BG systems and a laboratory method as comparison. Results: Three BG systems displayed significantly lower mean absolute relative deviations (MARD) (ACCU-Chek® Aviva Nano [5.4%], BGStar® [5.1%], iBGStar® [5.3%]) than 2 others (FreeStyle InsuLinx® [7.7%], OneTouch Verio®IQ [10.3%]). The measurement precision of all BG systems was comparable, but relative bias was also lower for the 3 systems with lower MARD (ACCU-Chek [1.3%], BGStar [–0.9%], iBGStar [1.0%]) compared with the 2 others (FreeStyle [–7.2%], OneTouch [8.9%]). Conclusions: This 3 range glucose clamp approach enables a systematic performance evaluation of BG systems under controlled and reproducible conditions. The random error of the tested BG systems was comparable, but some showed a lower systematic error than others. These BG systems allow an accurate glucose measurement at low, normal and high BG levels.