PMID- 32814455
OWN - NLM
STAT- MEDLINE
DCOM- 20220908
LR  - 20220920
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 16
IP  - 5
DP  - 2022 Sep
TI  - Impact of Two Different Reference Measurement Procedures on Apparent System 
      Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems.
PG  - 1076-1088
LID - 10.1177/1932296820948873 [doi]
AB  - BACKGROUND: Measurement accuracy has been assessed for many different blood 
      glucose monitoring systems (BGMS) over the years by different study groups. 
      However, the choice of the comparison measurement procedure may impact the 
      apparent level of accuracy found in such studies. MATERIALS AND METHODS: 
      Measurement accuracy of 18 different BGMS was assessed in a setting based on ISO 
      15197 using two different comparison methods in parallel: a glucose oxidase 
      (GOD)-based and a hexokinase (HK)-based method. Accuracy limits of ISO 15197 were 
      applied, and additional analyses were performed, including bias, linear 
      regression, and mean absolute relative difference (MARD) to assess the impact of 
      possible differences between comparison methods on the apparent level of 
      accuracy. RESULTS: While  approximately 80% of BGMS met the accuracy criteria of ISO 15197 when 
      compared with the respective manufacturers' reference measurement procedure, only 
      two-thirds did so against both comparison methods. The mean relative bias ranged 
      from -6.6% to +5.7% for the analysis against the GOD-based method and from -11.1% 
      to +1.3% for the analysis against the HK-based method, whereas MARD results 
      ranged from 3.7% to 9.8% and from 2.3% to 10.5%, respectively. Results of 
      regression analysis showed slopes between 0.85 and 1.08 (GOD-based method) and 
      between 0.81 and 1.01 (HK-based method). CONCLUSIONS: The results of this study 
      indicate that there are systematic differences between the reference measurement 
      procedures used for BGMS calibration as well as for system accuracy assessment. 
      Because of the potential impact on therapy of patients with diabetes resulting 
      from these differences, further steps toward harmonization of the measurement 
      procedures' results are important.
FAU - Freckmann, Guido
AU  - Freckmann G
AUID- ORCID: 0000-0002-0406-9529
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Baumstark, Annette
AU  - Baumstark A
AUID- ORCID: 0000-0002-3439-7400
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Jendrike, Nina
AU  - Jendrike N
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Mende, Jochen
AU  - Mende J
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Schauer, Sebastian
AU  - Schauer S
AUID- ORCID: 0000-0002-9873-0989
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Link, Manuela
AU  - Link M
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Pleus, Stefan
AU  - Pleus S
AUID- ORCID: 0000-0003-4629-7754
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
FAU - Haug, Cornelia
AU  - Haug C
AD  - Institut fur Diabetes-Technologie, Forschungs-und Entwicklungsgesellschaft mbH an 
      der Universitat Ulm, Ulm, Germany.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200819
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Blood Glucose)
RN  - EC 1.1.3.4 (Glucose Oxidase)
SB  - IM
MH  - Blood Glucose/analysis
MH  - *Blood Glucose Self-Monitoring/methods
MH  - Calibration
MH  - *Diabetes Mellitus
MH  - Glucose Oxidase
MH  - Humans
MH  - Reproducibility of Results
PMC - PMC9445332
OTO - NOTNLM
OT  - ISO 15197
OT  - MARD
OT  - bias
OT  - blood glucose monitoring system
OT  - linear regression
OT  - system accuracy
COIS- Declaration of Conflicting Interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: GF is general manager of the IDT (Institut fur 
      Diabetes-Technologie Forschungs-und Entwicklungsgesellschaft mbH an der 
      Universitat Ulm, Ulm, Germany), 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, i-SENS, LifeScan, 
      Menarini Diagnostics, Metronom Health, Novo Nordisk, PharmaSense, Roche, Sanofi, 
      Sensile and Ypsomed. The other authors are employees of IDT.
EDAT- 2020/08/21 06:00
MHDA- 2022/09/09 06:00
PMCR- 2021/08/19
CRDT- 2020/08/21 06:00
PHST- 2020/08/21 06:00 [pubmed]
PHST- 2022/09/09 06:00 [medline]
PHST- 2020/08/21 06:00 [entrez]
PHST- 2021/08/19 00:00 [pmc-release]
AID - 10.1177_1932296820948873 [pii]
AID - 10.1177/1932296820948873 [doi]
PST - ppublish
SO  - J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. doi: 10.1177/1932296820948873. 
      Epub 2020 Aug 19.