Table 2.
Statistical results for the investigated test strip lot compared against the manufacturer’s reference measurement procedure: percentage of results within ISO 15197 accuracy criteria, minimal deviation from the reference measurement procedure’s results containing at least 95% of values and relative bias according to Bland and Altman (systems are ranked alphabetically)
| # | BGMS | Reference measurement procedure | ±15 mg/dL/±15% | ±10 mg/dL/±10% | ±5 mg/dL/±5% | Minimal deviation containing at least 95% of values | Relative bias | N |
| % | % | % | mg/dL/% | % | ||||
| a | ABRA | GOD | 91.0 | 71.0 | 36.5 | ±16.8 | −2.9 | 200 |
| b | Accu-Chek Guide | HK | 100.0 | 97.5 | 82.0 | ±8.4 | −1.6 | 200 |
| c | AURUM | GOD | 97.5 | 88.0 | 55.5 | ±13.5 | 2.6 | 200 |
| d | CareSens Dual | GOD | 96.5 | 84.5 | 48.0 | ±13.8 | 0.8 | 200 |
| e | CERA-CHEK 1CODE | GOD | 94.5 | 82.0 | 51.0 | ±15.2 | −1.3 | 200 |
| f | ContourNext One | GOD | 100.0 | 99.5 | 77.0 | ±7.7 | 3.3 | 200 |
| g | eBsensor | GOD | 89.0 | 73.5 | 45.5 | ±19.7 | 3.9 | 200 |
| h | FreeStyle Freedom Lite | GOD | 99.5 | 91.5 | 46.5 | ±11.1 | −6.6 | 200 |
| i | GL50 evo | GOD | 97.5 | 86.5 | 59.5 | ±13.4 | 1.7 | 200 |
| j | GlucoCheck GOLD | GOD | 100.0 | 92.0 | 54.5 | ±11.2 | −4.5 | 200 |
| k | GlucoMen areo 2K | GOD | 98.0 | 86.0 | 49.0 | ±13.3 | 5.7 | 200 |
| l | GluNEO | HK* | 93.0 | 77.5 | 35.0 | ±16.2 | −0.6 | 200 |
| m | MyStar DoseCoach | GOD | 95.0 | 85.0 | 56.0 | ±14.4 | 4.3 | 200 |
| n | OneTouch Verio Flex | GOD | 99.0 | 93.5 | 58.5 | ±11.9 | 4.2 | 200 |
| o | Pic Gluco Test | GOD | 98.0 | 87.5 | 54.5 | ±12.2 | 3.3 | 200 |
| p | Rightest GM700S | GOD | 99.5 | 96.0 | 67.0 | ±9.4 | 2.1 | 200 |
| q | TRUEyou | GOD | 99.0 | 85.5 | 56.0 | ±13.6 | 0.9 | 200 |
| r | WaveSense JAZZ Wireless | GOD | 95.0 | 84.0 | 55.0 | ±14.4 | 4.2 | 200 |
*No information about the manufacturer’s reference measurement procedure was available at the time of manuscript submission. Based on literature research19 and the investigator’s experience regarding reliability of measurement results, the HK-based procedure was assigned as primary reference measurement procedure for system accuracy evaluation.
GOD, glucose oxidase; HK, hexokinase.