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Performance of 10 systems for self-monitoring of blood glucose by trained healthcare professionals and in the hands of the users.

To the Editor:

Accurate and reproducible blood glucose results are important for adequate therapeutic decision for people with diabetes. Few studies assessing the accuracy of systems for self-monitoring of blood glucose (SMBG) (1) systems against the requirements from the International Organization for Standardization (ISO) standard 15197:2013 (1) have been published, and none of them has addressed analytical quality in the hands of the users. To our knowledge, no studies have evaluated SMBG systems against the requirements for accuracy in the new US Food and Drug Administration (FDA) draft guidance for SMBG systems for over-the-counter use (2). The aim of this study was to assess the accuracy of10 SMBG systems under optimal conditions achieved by biomedical laboratory scientists (BLSs) and by people with diabetes against the minimum accuracy requirements specified in ISO 15197:2013, ISO 15197:2003, and FDA draft guidance.

We used data from 10 SMBG system evaluations performed from 2005 to 2013 by the Scandinavian evaluation of laboratory equipment for primary healthcare (SKUP). The evaluations were carried out in line with common guidelines and standardized protocols according to international recommendations. All measurements on each SMBG system were compared with a glucose hexokinase method. Standard reference material from the National Institute of Standards and Technology was used to secure traceability of the comparison method. Detailed reports from each evaluation including recruitment of individuals with diabetes, design of the evaluations, lot numbers, information about reagents and dates of expiration, and traceability of the comparison method can be found at SKUP's web page (www.SKUP.nu). General approval for the evaluations was obtained from the Norwegian Regional Committee for medical research. We calculated the percentage of results within the limits for minimum requirements for accuracyfrom ISO 15197:2013 (1) and FDA (2). A description of calculation of imprecision and bias can be found at www.SKUP.nu. Statistical significance was set to 5%.

All the SMBG systems except GlucoMen LX fulfilled the minimum requirements for accuracy from ISO 15197:2013 (1) and the FDA draft guidance (2) when the measurements were performed by a BLS (Table 1). When people with diabetes performed the measurements, 6 of the 10 SMBG systems fulfilled the minimum requirements from ISO 15197:2013 and FDA (Table 1). All SMBG systems fulfilled the minimum requirements for accuracy from ISO 15197:2003 when the measurements were performed by both BLSs and people with diabetes (Table 1).

The repeatability (CV) of all the SMBG systems obtained by BLS under optimal conditions was below a recommended limit of 5%. When people with diabetes performed the measurements, all SMBG systems except Dana DiabeCare IISG and GlucoMen LX had a CV <5%. Significant bias from the comparison method varied between -5.9% and +7.7% depending on the SMBG system and glucose level. There was no overall correlation between the year of evaluation and mean precision or bias.

Our accuracy results are in accordance with a study published in 2014 evaluating 12 SMBG systems against the accuracy requirements in ISO 15197:2013 (3). However, that evaluation was performed in a laboratory by trained clinical personnel under controlled conditions and not by intended users.

In the present study, all 10 SMBG systems met the minimum accuracy requirements from ISO 15197:2003, which are less strict than the minimum requirements in ISO 15197:2013 (Table 1). In a study performed in 1998, none of the 5 SMBG systems tested fulfilled the minimum requirements in ISO 15197:2003 in the hands of the user, and only 2 of the 5 SMBG systems met the requirements when the measurements were performed by a BLS (4). Three of 9 SMBG systems did not fulfill the requirements in ISO 15197:2003 in a study performed between 2004 and 2006, whereas all met the minimum requirements when BLSs did the measurements (5). Thus, it seems that SMBG systems have become more user-friendly: the difference between trained personnel and end users is less in the present study compared with previous studies (4, 5). Even the FDA requirements for user accuracy, which are stricter in the low glucose range, were fulfilled by 6 of the 10 SMBG systems in our study.

In conclusion, we show that 9 of the 10 SMBG systems fulfilled the minimum requirements for accuracy specified in ISO 15197:2013 and in the FDA draft guidance when BLSs performed the measurements. Furthermore, 6 of the 10 SMBG systems fulfilled the requirements when people with diabetes performed the measurements. Comparison of the data reviewed here with earlier published data suggests that the analytical quality and user-friendliness of the SMBG systems have improved over the last 10-16 years.

Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following3 requirements: (a)significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article.

Authors' Disclosures or Potential Conflicts of Interest: No authors declared any potential conflicts of interest.

Acknowledgments: We thank all those with diabetes participating in the SKUP evaluations and the laboratory at Haraldsplass Deaconess Hospital performing the analysis on the comparison methods.

References

[1.] In vitro diagnostic test systems--requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus, 2nd ed. Geneva: ISO; 2013. ISO 15197:2013(2nd ed. of IS015197:2003).

[2.] FDA. Self-monitoring blood glucose test systems for over-the-counteruse.http://www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM380327.pdf (Accessed November 2014).

[3.] Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther 2014;16:113-22.

[4.] Skeie S, Thue G, Nerhus K, Sandberg S. Instruments for self-monitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem 2002;48:994-1003.

[5.] Kristensen GBB, Monsen G, Skeie S, Sandberg Standardized evaluation of nine instruments for self-monitoring of blood glucose. Diabetes Technol Ther 2008;10:467-77.

Una O. Solvik [2]* Marianne Risa [3] Camilla E. Jacobsen [3] Grete Monsen [3] Sverre Sandberg [2,3,4]

[2] Department of Global Health and Primary Care Faculty of Medicine and Dentistry University of Bergen Bergen, Norway

[3] Norwegian Quality Improvement of Primary Care Laboratories (Noklus) Haraldsplass Deaconess Hospital Bergen, Norway

[4] Laboratory of Clinical Biochemistry Haukeland University Hospital Bergen, Norway

* Address correspondence to this author at: Noklus, P.O. Box 6165 N-5892 Bergen, Norway Fax+47-55-97-95-10 E-mail una.solvik@igs.uib.no

Previously published online at DOI: 10.1373/clinchem.2014.236760

(1) Nonstandard abbreviations: SMBG, self-monitoring of blood glucose; ISO, International Organization for Standardization; FDA, US Food and Drug Administration; BLS, biomedical laboratory scientist; SKUP, Scandinavian evaluation of laboratory equipment for primary health care.
Table 1. Assessment of accuracy for SMBG systems according
to IS015197:2003, ISO 15197:2013, and FDA draft guidance as
performed by BLSs and people with diabetes.

SMBG system            Manufacturer                   Year/SKUP
                                                      evaluation no.

Accu-ChekAviva         Roche Diagnostics              2005/44
                                                      2005/44
                                                      2013/98 (d)
Accu-Chek Mobile       Roche Diagnostics              2009/74
                                                      2009/74
                                                      2013/99 (d)
Ascensia BREEZE2       Bayer Healthcare               2007/59
                                                      2007/59
ContourXT              Bayer Healthcare               2012/94
                                                      2012/94
DANA DiabeCare IISG    SOOIL Development Co.          2008/66
                                                      2008/66
FreeStyle Lite         Abbott Diabetes Care           2007/64
                                                      2007/64
                                                      2010/89 (d)
GlucoMen LX            Menarini Diagnostics           2009/71
                                                      2009/71
Mendor Discreet        Mendor Oy                      2012/95
                                                      2012/95
mylife Unio            Ypsomed Bionime                2013/100
                                                      2013/100
OneTouch Verio         LifeScan, Johnson & Johnson    2011/86
                                                      2011/86

SMBG system            Measurement             n
                       performed by:

Accu-ChekAviva         BLS                     75
                       People with diabetes    75
                       BLS                     90
Accu-Chek Mobile       BLS                     86
                       People with diabetes    86
                       BLS                     90
Ascensia BREEZE2       BLS                     77
                       People with diabetes    75
ContourXT              BLS                     82
                       People with diabetes    82
DANA DiabeCare IISG    BLS                     83
                       People with diabetes    83
FreeStyle Lite         BLS                     76
                       People with diabetes    76
                       BLS                     90
GlucoMen LX            BLS                     84
                       People with diabetes    84
Mendor Discreet        BLS                     79
                       People with diabetes    79
mylife Unio            BLS                     81
                       People with diabetes    81
OneTouch Verio         BLS                     87
                       People with diabetes    87
                       Results within ISO 15197 limits? (%)
SMBG system            ISO 15197:2003(a)    ISO 15197:2013 (b)

Accu-ChekAviva         Yes(99)              Yes (96)
                       Yes (99)             No (93)
                       Yes (99)             Yes (98)
Accu-Chek Mobile       Yes (100)            Yes (98)
                       Yes (99)             Yes (97)
                       Yes (98)             Yes (96)
Ascensia BREEZE2       Yes (100)            Yes (99)
                       Yes (100)            Yes (97)
ContourXT              Yes (100)            Yes (100)
                       Yes (100)            Yes (100)
DANA DiabeCare IISG    Yes (100)            Yes (99)
                       Yes (98)             No (94)
FreeStyle Lite         Yes (100)            Yes (100)
                       Yes (100)            Yes (99)
                       Yes (100)            Yes (100)
GlucoMen LX            Yes (99)             No (92)
                       Yes (96)             No (94)
Mendor Discreet        Yes (100)            Yes (100)
                       Yes (99)             Yes (96)
mylife Unio            Yes (100)            Yes (100)
                       Yes (100)            Yes (99)
OneTouch Verio         Yes (100)            Yes (99)
                       Yes (99)             No (91)

                       Results within ISO   Results within
                       15197 limits? (%)    FDA limits? (%)
SMBG system            95% <15% (c)           99% <20%

Accu-ChekAviva         Yes (96)              Yes (99)
                       No (93)               Yes (99)
                       Yes (98)              Yes (99)
Accu-Chek Mobile       Yes (98)              Yes (100)
                       Yes (95)              Yes (99)
                       Yes (96)              No (98)
Ascensia BREEZE2       Yes (99)              Yes (100)
                       Yes (97)              Yes (100)
ContourXT              Yes (100)             Yes (100)
                       Yes (99)              Yes (100)
DANA DiabeCare IISG    Yes (98)              Yes (100)
                       No (94)               No (98)
FreeStyle Lite         Yes (100)             Yes (100)
                       Yes (99)              Yes (100)
                       Yes (100)             Yes (100)
GlucoMen LX            No (91)               Yes (99)
                       No (94)               No (96)
Mendor Discreet        Yes (100)             Yes (100)
                       Yes (96)              Yes (99)
mylife Unio            Yes (100)             Yes (100)
                       Yes (98)              Yes (100)
OneTouch Verio         Yes (99)              Yes (100)
                       No (91)               Yes (99)

(a) Minimum requirement: 95% of the results must be within
15 mg/dL(0.83 mmol/L) at glucose concentrations <76 mg/dL
(<4.2 mmol/L)and within 20% at glucose concentrations
[less than or equal to]76 mg/dL(>4.2 mmol/L) vs a comparison method.

(b) Minimum requirement: 95% of the results must be within
15 mg/dL(0.83 mmol/L) at glucose concentrations <100 mg/dL
(<5.55 mmol/L) and within 15% at glucose concentrations
[less than or equal to]100 mg/dL ([less than or equal to]5.55 mmol/L)
vs a comparison method.

(c) 95% of all SMBG results must be within 15% of the reference
measurement and 99% of all SMBG results must be within 20% of the
reference measurement.

(d) Reexamined inasecond evaluation by BLS after a modification
of the test strip chemistry.
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Publication:Clinical Chemistry
Article Type:Letter to the editor
Date:May 1, 2015
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