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



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.



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%]).



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.
Profil, Neuss, Germany eric.zijlstra@profil.com.
Eric
E
Zijlstra
Profil, Neuss, Germany.
Lutz
L
Heinemann
Profil, Neuss, Germany.
Annelie
A
Fischer
Profil, Neuss, Germany.
Christoph
C
Kapitza
D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D005260:Female; D015309:Glucose Clamp Technique; D006801:Humans; D006943:Hyperglycemia / Q000097:blood; D007003:Hypoglycemia / Q000097:blood; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results
D001786:Blood Glucose
accuracy; blood glucose self-monitoring; glucose clamp; glucose meters