Patient and health care provider evaluations are critical in establishing the accuracy and usability of new blood glucose meter systems. The objective of our study was to evaluate the clinical performance and ease of use of a blood glucose meter that uses a 10-test disk (Ascensia Breeze meter system, Bayer Healthcare LLC, Elkhart, IN). Meter capillary blood glucose results were compared with laboratory glucose results from 100 subjects with diabetes at two diabetes centers. Five health care professionals also tested subject blood samples. The subjects completed a questionnaire rating the ease of use of the meter, and their ability to learn to use the meter was also evaluated. Analytical accuracy of the meter system was assessed using ISO 15197:2003 performance criteria. Subject and health care professional meter glucose results were within 20% of laboratory glucose results [or 15 mg/dL (0.83 mmol/L) for specimens with less than 75 mg/dL (4.17 mmol/L) glucose levels] for 93.4% and 94.4% of results, respectively. Clinical accuracy of the system was evaluated using Parkes error grid analysis. The error grid analyses showed that 100% of subject and health care professional meter blood glucose results were in Zones A (92%) and B (8%). In the ease-of-use questionnaire, 91% of subject ratings of the meter were favorable. Subjects learned to operate the meter properly using the meter instructional material with little or no assistance from the health care professionals. The 10-test disk was rated as a prominent favorable feature. The new meter was accurate and precise in the hands of subjects with diabetes and health care professionals. Subjects found the meter easy and intuitive to learn to use. The study subjects were able to correctly use the meter after independently reviewing the user guide.

The results of a psychometric study of the Test of Patient Knowledge are reported. The 50-item, multiple-choice test, developed by Etzwiler and associates at the International Diabetes Center, consists of a total score and seven subscores based on seven nonoverlapping content categories: nutrition, insulin, general knowledge, methods of control, pattern control, exercise, and complications. The results described herein provide evidence for the validity of the test (content, concurrent, and discriminant validity), a high level of reliability (Cronbach's alpha = .88), readability for the layperson at the 7th- to 8th-grade level, and sensitivity to instructional gains. The literature on psychometric research with other tests of patient knowledge of diabetes is reviewed and compared with the results of this study.

A 5-day patient education program, taught on an outpatient basis, was evaluated to determine its effect on metabolic control as reflected by glycosylated hemoglobin test values. A quasi-experimental design was used, consisting of a pretest, a posttest, and a follow-up assessment made approximately 6 months after the posttest. The 72 experimental and 324 comparison subjects all had insulin-dependent diabetes mellitus (IDDM), were between 14 and 78 years of age, and had a duration of diabetes ranging from 1 to 20 years. The experimental group demonstrated a statistically significant improvement in Hb A1 values from pre- to posttest and sustained these posttest levels upon follow-up, although not at statistically significant levels. The comparison group showed no pre- to posttest difference, but demonstrated an improvement from posttest to follow-up assessment.

This study examined whether or not patients (n =57) of specialists in diabetes differed from patients (n=211) ofnonspecialists in terms of their knowledge about diabetes before and after a standardized patient education program in diabetes. A specialist was defined as a physician whose practice consisted of 50 % or more diabetic patients. Patient knowledge about diabetes was measured with a 50-item ques tionnaire consisting of seven subscores and a total score. Prior to the program, the two groups did not differ on five of the subscores nor on the total score. There were statistically significant differences on two of the subscores on the pretest: Methods of Control and Pattern Control, with the specialist group scoring better than the nonspecialist group. No differences on any of the scores were found at the end of the program, nor were there differ ences in the amount of knowledge gained during the program. Several interpretations of these findings are suggested and the implications for patient and physician education and the need for further research are discussed.

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