Fructosamine is an
indicator of overall
glycemic control for a 10-14-day time frame, medium-term marker, versus the 90-day average indicated by the
hemoglobin A1c (A1C) test. The utility of the home
fructosamine test for management of persons with diabetes remains undefined. The primary objectives of this study were (1) to compare the annual A1C results of subjects monitoring weekly
fructosamine with those receiving usual care, (2) to identify the number of subjects achieving goal A1C, and (3) to determine if the addition of a weekly
fructosamine test changed a subject's quality of life. This was a prospective, randomized, multicenter, controlled trial. Subjects were recruited from three sites and randomly assigned to collect weekly
fructosamine in addition to daily
glucose (Group 1) or to receive usual care of daily
glucose collection (Group 2). Follow-up occurred at 3-month intervals for a year. Baseline and quarterly A1C tests were collected. Quality of life assessment was conducted at baseline and at the final study visit. Seventy-two subjects were randomized. Demographic and whole blood assessments were similar between the two groups at baseline. The mean percent change of A1C from baseline to final study visit in Group 1 (-0.52 +/- 1.5) was not statistically different than Group 2 (-0.86 +/- 1.4) (P = 0.320). Seven subjects in each group achieved A1C of less than 7% (P = 0.532). No change in quality of life between or within the two groups was observed (P > 0.05) for each area of concern.
Blood glucose monitoring alone was shown to be superior to the additional
fructosamine testing after 1 year of treatment; however, weekly
fructosamine testing demonstrated a decrease in A1C earlier and more consistently throughout the study. Despite glycemic improvement, the number of subjects attaining American Diabetes Association-defined A1C goals was not different between the treatment groups. Quality of life did not change with the addition of a weekly
fructosamine test.