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

J Diabetes Sci Technol. 2016 Nov 1;10(6):1316-1323. doi: 10.1177/1932296816668373. Print 2016 Nov.


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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring / methods*
  • Diabetes Mellitus, Type 1 / blood*
  • Female
  • Glucose Clamp Technique
  • Humans
  • Hyperglycemia / blood
  • Hypoglycemia / blood
  • Male
  • Middle Aged
  • Reproducibility of Results


  • Blood Glucose