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Abstract
Background:
The performance of the self-monitoring of blood glucose in patients with diabetes should be properly evaluated to ensure strict glycemic control. This study evaluated the self-testing Blood Glucose Monitoring System GlucoDr.S™ (All Medicus Co., Ltd., Korea).
Methods:
This study recruited 120 patients. Use of the glucometer was evaluated according to ISO 15197:2013 guidelines. The YSI 2300 STAT PLUS Glucose Analyzer (YSI Life Sciences, USA) was used as the reference device.
Results:
The standard deviation and coefficients of variation ranges for measurement repeatability and intermediate measurement precision conducted with 10 meters and 3 reagent lots on the same day were 2.7–3.2 mg/dL (<100 mg/dL) and 3.4–3.7% (≥100 mg/dL), respectively, and 3.7 mg/dL (<100 mg/dL) and 2.1–2.6% (≥100 mg/dL), respectively. Each coefficient of determination (R2) for linearity of the 3 reagent lots was >0.99. The influence effect of hematocrit and the 24 interference agents was not significant, except for xylose. A system accuracy test was conducted with 100 subjects taking duplicate measurements from each of the 3 reagent lots. When glucose levels were <100 mg/dL and ≥100 mg/dL, >95% of the samples were within ±15 mg/dL and within ±15% of the average measured values of the reference measurement, respectively. In Consensus Error grid analysis, all results were distributed in zone A and B. The results of the user performance evaluation using 115 lay persons were also included in the acceptance range.
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Fig. 1.
Linearity results of the three lots of GlucoDr.S™. Linearity test was conducted with 9 m, 3 reagent lots, and 11 sample levels. One tester was performed with each combination of reagent lot and sample within one day. Good linearity was indicated at R2≥0.99.
Fig. 2.
Packed cell volume test. (A) glucose level: 30–50 mg/dL; (B) 96–144 mg/dL; (C) 280–420 mg/dL.
Fig. 3.
System accuracy of GlucoDr.S™. (A) Difference-plots of capillary blood samples; (B) Clarke error grid analysis of capillary blood samples; (C) Difference-plots of venous blood samples; (D) Clarke error grid analysis of venous blood samples. A zone: No effect on clinical action, B zone: Little or no effect on clinical outcome.
Fig. 4.
User performance test. (A) Difference-plots; (B) Clarke error grid analysis. A zone: No effect on clinical action, B zone: Little or no effect on clinical outcome.
Table 1.
Data analysis and presentation for precision of GlucoDr.S™
| Measurement repeatability∗ | Intermediate measurement precision† | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Level 1 | Level 2 | Level 3 | Level 4 | |
| Standard concentration, YSI (mg/dL) | 39.1 | 85.5 | 121.0 | 205.0 | 352.0 | 37.2 | 118.0 | 353.0 | 520.0 |
| Mean (mg/dL) | 42.3 | 81.9 | 113.0 | 185.0 | 315.0 | 38.0 | 119.0 | 353.0 | 514.0 |
| SD (mg/dL) | 2.7 | 3.2 | 4.2 | 6.3 | 11.7 | 1.4 | 2.6 | 7.4 | 13.3 |
| CV (%) | 6.3 | 3.9 | 3.7 | 3.4 | 3.7 | 3.7 | 2.2 | 2.1 | 2.6 |
∗ Measurement repeatability test was conducted with 10 meters, 3 reagent lots, and 5 sample levels (Level 1, 30–50 mg/dL; Level 2, 51–110 mg/dL; Level 3, 111–150 mg/dL; Level 4, 151–250 mg/dL; Level 5, 251–400 mg/dL) with glucose concentrations representing hyperglycemic, euglycemic and hypoglycemic conditions. Ten measurements were performed with each combination of meter, reagent lot and sample. In other words, each sample (level) was measured 300 times (10 meters × 3 reagent lots × 10 measurements);
† Intermediated measurement precision test was performed with control materials. The evaluation was conducted with one measurement of each sample per day and 10 meters, 3 reagent lots, and 4 sample levels (Level 1, 30–50 mg/dL; Level 2, 96–144 mg/dL; Level 3, 280–420 mg/dL; Level 4, 425–550 mg/dL) with glucose concentrations representing hyperglycemic, euglycemic and hypoglycemic conditions over 10 days. In other words, each sample (level) was measured 300 times (10 meters × 3 reagent lots × 1 measurement/day ×10 days).
Table 2.
Paired difference interference testing∗ of GlucoDr.S™
∗ The interference effects were described in the instructions for use if they met ei ther of the following performance criteria. — For glucose concentrations <100 mg/dL, the average difference between th test sample and the control sample exceeds 10 mg/dL. — For glucose concentrations ≥100 mg/dL, the average difference between th test sample and the control sample exceeds 10%. Abbreviations: L-DOPA, L-3,4-dihydroxyphenylalanin; NT, Not tested.
Table 3.
Dose response interference testing of GlucoDr.S™
| Substance∗ | Maximum test oncentration (mg/dL) |
Upper concentration limit at which there is no interference (mg/dL) |
|
|---|---|---|---|
| Glucose levels, 50–100 mg/dL | Glucose levels, 250–350 mg/dL | ||
| Pralidoxime iodide (PAM) | 80 | 20 | 10 |
| Uric acid | 24 | 8 | 24 |
| Xylose | 20 | 11 | 20 |
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