A prospective, randomized, multicentered controlled trial to compare the annual glycemic and quality outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care.

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.

RCT Entities:   Population Interventions Outcomes