Clinical Chemistry Email Content Delivery
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 50: 1068-1071, 2004; 10.1373/clinchem.2004.031575
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Data Supplement
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (15)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Kristensen, G. B.B.
Right arrow Articles by Sandberg, S.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Kristensen, G. B.B.
Right arrow Articles by Sandberg, S.
Related Collections
Right arrow Evidence Based Laboratory Medicine and Test Utilization
(Clinical Chemistry. 2004;50:1068-1071.)
© 2004 American Association for Clinical Chemistry, Inc.

Technical Briefs

Standardized Evaluation of Instruments for Self-Monitoring of Blood Glucose by Patients and a Technologist

Gunn B.B. Kristensen1,a, Kari Nerhus1, Geir Thue1 and Sverre Sandberg1,2

1 NOKLUS, Norwegian Center for Quality Improvement of Primary Care Laboratories, Division of General Practice, Department of Public Health and Primary Health Care, University of Bergen, Ulriksdal 8c, N-5009, Norway;2 Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway

aauthor for correspondence: fax 47-55586710, e-mail gunn.kristensen@isf.uib.no

The first 300 words of the full text of this article appear below.

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 . . . [Full Text of this Article]




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
J. Mahoney and J. Ellison
Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports
Clin. Chem., June 1, 2007; 53(6): 1122 - 1128.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Chem.Home page
G. B.B. Kristensen, K. Nerhus, G. Thue, and S. Sandberg
Results and Feasibility of an External Quality Assessment Scheme for Self-Monitoring of Blood Glucose
Clin. Chem., July 1, 2006; 52(7): 1311 - 1317.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Chem.Home page
G. B.B. Kristensen, N. G. Christensen, G. Thue, and S. Sandberg
Between-Lot Variation in External Quality Assessment of Glucose: Clinical Importance and Effect on Participant Performance Evaluation
Clin. Chem., September 1, 2005; 51(9): 1632 - 1636.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Chem.Home page
W. E. Winter
A Rosetta Stone for Insulin Treatment: Self-Monitoring of Blood Glucose
Clin. Chem., June 1, 2004; 50(6): 985 - 987.
[Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2004 by the American Association for Clinical Chemistry.