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J Diabetes Sci Technol. 2016 Nov 1;10(6):1316-1323. Print 2016 Nov.

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

Author information

1
Profil, Neuss, Germany eric.zijlstra@profil.com.
2
Profil, Neuss, Germany.

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.

KEYWORDS:

accuracy; blood glucose self-monitoring; glucose clamp; glucose meters

PMID:
27605592
PMCID:
PMC5094346
DOI:
10.1177/1932296816668373
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EZ, AF, and CK are employees of Profil. LH is a scientific consultant for Profil, and both LH and CK are shareholders within the company. Profil has collaborations with several pharmaceutical and biotechnology companies. This investigator initiated study was supported by Sanofi, which is the distributor of the BGStar and iBGStar BG meter systems. Results of this trial were presented at the following international scientific conferences in poster format: 74th Scientific Sessions, San Francisco, CA, USA, June 13-17, 2014; 14th Annual Diabetes Technology Meeting, Bethesda, MD, USA, November 6-8, 2014; The 8th International Conference on Advanced Technologies & Treatments for Diabetes, Paris, France, February 18-21, 2015.

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