Standardized evaluation of nine instruments for self-monitoring of blood glucose.
BACKGROUND
Instruments for self-monitoring of blood glucose (SMBG) should undergo a standardized evaluation including a user-test before being marketed. In this study the results from standardized evaluations of nine different SMBG instruments are presented, and the standardized evaluation is discussed.


METHODS
Approximately 80 diabetes patients using three lots of test strips participated in each evaluation. Half of the patients were educated in how to use the meter, and the evaluations were carried out by both medical laboratory technologists (MLTs) and patients. Questionnaires were used to assess the user manual and the user-friendliness of the instrument.


RESULTS
The imprecision obtained by the patients (coefficients of variation [CVs] of 3.2-8.1%) were generally higher compared to that by the MLT (CVs of 2.3-5.9%). Three of the nine instruments did not achieve the quality goal based on the recommendation in the International Organization for Standardization's ISO 15197 guideline in the hands of diabetes patients. The bias from the comparison method ranged from -10.4% to +3.2%. There were significant lot-to-lot variations and hematocrit effects for some of the instruments. Temperature difference between the instruments and the test strip caused deterioration of the quality in one instrument. The user-friendliness was in general acceptable.


CONCLUSIONS
The quality of instruments for SMBG seems to have improved during recent years, although there are still analytical problems. A standardized evaluation protocol is necessary and should be regularly revised taking into account the development of new technology and the needs of the patients.
Kristensen
Gunn B B
GB
NOKLUS, Norwegian Quality Improvement of Primary Care Laboratories, Section for General Practice, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway. gunn.kristensen@noklus.no
Monsen
Grete
G
Skeie
Svein
S
Sandberg
Sverre
S
D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004867:Equipment Design; D006801:Humans; D013677:Medical Laboratory Science; D015588:Observer Variation; D010353:Patient Education as Topic; D011934:Reagent Strips; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires
D011934:Reagent Strips