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Cited by 68Diabetes Management and ResearchClinical Laboratory Practices and Quality ControlDiabetes Management and Education

Standardized evaluation of instruments for self-monitoring of blood glucose by patients and a technologist

Kristensen, Gunn B B, Nerhus, Kari, Thue, Geir, Sandberg, Sverre·2004·Clinical Chemistry
DOI 10.1373/clinchem.2004.031575
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Abstract

Self-monitoring of blood glucose (SMBG) is recommended to improve metabolic control for patients with diabetes because tight glycemic control can decrease microvascular complications in individuals with type 1 and type 2 diabetes (1)(2). The worldwide market for SMBG is $2.7 billion per year, with annual growth estimated to be 10–12% (3). The performance of these instruments is therefore an important issue. In most studies evaluating instruments for SMBG, the patient is not involved, although user errors account for a large portion of the total error in SMBG (4). In International Organization for Standardization document ISO/FDIS 15197, it is therefore recommended that a user performance evaluation should be performed in addition to testing by a medical laboratory technologist (MLT) (5). We have developed a procedure based on these recommendations in which instruments are tested simultaneously by an experienced technologist and a group of patients under the same conditions, using blood from the same patients. The procedure was evaluated with two instruments: Glucometer Dex from Bayer (1999) and GlucoMen Glyco from Menarini (2002). Norwegian patients with diabetes (type 1 and type 2) participated. For each meter, 100 patients were randomly divided into two groups, as shown in Supplement 1 of the Data Supplement that accompanies the online version of this Technical Brief at http://www.clinchem.org/content/vol50/issue6/. Before the evaluation, one group was given specific training by a MLT (1–2 h) on how to use the new meter, in addition to standard written instructions, whereas the other group received the meter by mail with the same standard instructions. Three lots of strips were used in the test. After receiving their new meter, the user manual, and 50 strips, the patients familiarized themselves with the meter for 2 weeks. In the period between 2 and 4 weeks, the patients performed five glucose measurements in duplicate on themselves on 5 different days. After 4 weeks, the patients met individually with the MLT for a consultation. During the consultation, the patients first performed two measurements on themselves with no instructions from the MLT. Within 5 min, the MLT took a sample from a different finger. With this blood sample, glucose measurements were performed twice on two different meters and twice with the reference method. Because the meters had no underfill detection, the MLT visually checked the strips and marked all measurements with strips not completely filled with blood. The MLT also observed whether the instrument was coded correctly. Finally, the patients completed two questionnaires, one about the user manual and one about the user-friendliness of the device. The study protocol was approved by the Norwegian Regional Committee for Medical Research Ethics. The comparison method for the Glucometer Dex was a glucose dehydrogenase method using hemolyzed blood with reagents from Roche Diagnostics (Unimate 7) run on a Cobas Fara centrifugal analyzer (Roche Diagnostics). The comparison method for GlucoMen Glyco was a method that measures glucose in plasma on an Advia 1650 with reagents from Bayer (Glucose Hexokinase Method II; prod. no. B01-597-01). Both methods were verified by SRM 965 from the NIST and by control solutions verified by the isotope dilution–gas chromatography/mass spectrometry reference method. According to ISO/FDIS 15197 (5) and the NCCLS (7), the number of measurements deviating more than ±20% (results ≥4.2 mmol/L) and >0.83 mmol/L (results <4.2 mmol/L) should be <5%. None of the meters met these requirements when used by patients, but the GlucoMen Glyco met the requirements when used by the MLT (Fig. 1 and Table 1 ). However, several other, usually stricter quality specifications have been suggested (8)(9)(10)(11), e.g., the American Diabetes Association suggests a total error of ±10% (9). Analytical quality. Percentage of measurements (first of duplicate) that deviate from the reference method (mean of duplicate) by more than the difference allowed by the ISO standard (5). When calculating the accuracy only measurements from the MLT’s instrument for which all three lots were included are presented. Calculated from duplicate measurements from patients or from the MLT. When calculating the imprecision for instruments used by the MLT, measurements for both meters were included. Mean (95% confidence interval). Results were excluded based on the criterion promoted by Burnett (16). 95% confidence interval in parentheses. Analytical quality. Percentage of measurements (first of duplicate) that deviate from the reference method (mean of duplicate) by more than the difference allowed by the ISO standard (5). When calculating the accuracy only measurements from the MLT’s instrument for which all three lots were included are presented. Calculated from duplicate measurements from patients or from the MLT. When calculating the imprecision for instruments used by the MLT, measurements fo

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Authors
Kristensen, G. B. B., Nerhus, K., Thue, G., & Sandberg, S.
Affiliations
  • University of Bergen (NO)
  • Haukeland University Hospital (NO)
Corresponding author
Kristensen, Gunn B B
ORCID
Venue
Clinical Chemistry
Publisher
Oxford University Press (OUP)
Published
2004-06-01
Volume
50
Issue
6
Pages
1068-1071
ISSN
  • 0009-9147 (ISSN-L)
  • 1530-8561
DOI
10.1373/clinchem.2004.031575
OpenAlex
W2140989397
Cited by
68
References
14
Citations by year
2026: 1 · 2022: 3 · 2021: 1 · 2020: 1 · 2019: 1 · 2017: 2 · 2016: 2 · 2015: 1 · 2014: 2 · 2013: 2 · 2012: 4
FWCI
4.56
Type
journal article
Language
en
Open access
closed
Licence
academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations
  • Clinical Chemistry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
self-monitoring of blood glucose, blood glucose meters, user performance evaluation, user errors, meter accuracy, type 1 diabetes, type 2 diabetes, glycemic control, reference method comparison
MeSH terms
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Humans, Reference Standards, Blood Glucose Self-Monitoring, Medical Laboratory Personnel

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