System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015

Abstract

Objective: Accuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data.

Research design and methods: The BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou, and WaveSense JAZZ Wireless were tested using capillary blood from 100 different subjects and assessing the percentage of results within ±15 mg/dL (0.83 mmol/L) or 15% of comparison method results for BG concentrations below or above 100 mg/dL (5.55 mmol/L), respectively. In addition, the minimal deviation from comparison method results within which ≥95% of results of the respective BGMS were found was calculated.

Results: In total, 14 BGMS had ≥95% of results within ±15 mg/dL (0.83 mmol/L) or ±15% and 3 BGMS had ≥95% of results within ±10 mg/dL (0.55 mmol/L) or ±10% of the results obtained with the comparison method. The smallest deviation from comparison method results within which ≥95% of results were found was ±7.7 mg/dL (0.43 mmol/L) or ±7.7%; the highest deviation was ±19.7 mg/dL (1.09 mmol/L) or ±19.7%.

Conclusions: This accuracy evaluation shows that not all CE-labeled BGMS fulfill accuracy requirements of ISO 15197 reliably and that there is considerable variation even among BGMS fulfilling these criteria. This safety-related information should be taken into account by patients and healthcare professionals when making therapy decisions.

Trial registration number: NCT03737188.

Keywords: accuracy; blood glucose monitors; blood glucose self-monitoring; health care research.

Conflict of interest statement

Competing interests: GF is general manager of the IDT, which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. GF/IDT have received speakers’ honoraria or consulting fees from Abbott, Ascensia, Dexcom, LifeScan, Menarini Diagnostics, Metronom Health, Novo Nordisk, Roche, Sanofi, Sensile, and Ypsomed. SP, AB, NJ, JM, ML, EZ, and CH are employees of IDT; no competing financial interests exist.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Difference plots for 18 blood glucose monitoring systems (BGMS) (n=200 for each difference plot) when evaluated against the manufacturer’s reference measurement procedure. Red/green solid lines: system accuracy criterion A in accordance to ISO 15197, ±15 mg/dL (0.83 mmol/L)/±15% (green lines were used if accuracy criterion a was fulfilled, red lines were used if accuracy criterion a was not fulfilled). Gray solid lines: accuracy limits of ±10 mg/dL (0.56 mmol/L)/±10%. Blue dashed lines: minimal deviation from the reference measurement procedure’s results within which ≥95% of results of the respective BGMS were found. For system l, no information about the manufacturer’s reference measurement procedure was available at the time of manuscript submission. Based on literature research and the investigator’s experience regarding reliability of measurement results, the hexokinase (HK)-based procedure was assigned as primary reference measurement procedure for system accuracy evaluation. If values were found outside the y-axis limits of ±80 mg/dL, a label was added to the upper or lower left corner of the BGMS’ subgraph and arrows indicate at which concentrations these values were found. GOD, glucose oxidase.

Figure 2

Minimal deviation of measurement results obtained with the tested blood glucose monitoring system (BGMS) (n=200 for each BGMS) from the respective manufacturer’s reference measurement procedure’s measurement results containing at least 95% of values (blue dashed lines; represented by blue funnels in figure 1A and B). For system l, no information about the manufacturer’s reference measurement procedure was available at the time of manuscript submission. Based on literature research and the investigator’s experience regarding reliability of measurement results, the hexokinase (HK)-based procedure was assigned as primary reference measurement procedure for system accuracy evaluation. Green/red solid lines: accuracy limits of ±15 mg/dL (0.83 mmol/L)/±15% (green lines were used if accuracy criterion a was fulfilled, red lines were used if accuracy criterion a was not fulfilled). Gray solid lines: accuracy limits of ±10 mg/dL (0.56 mmol/L)/±10%. BGMS with HK as manufacturer’s reference measurement procedure are marked with a blue open circle on the x-axis.