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

[摘要] 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 …

[学科分类] 过敏症与临床免疫学