A prospective, randomized, multicentered controlled trial to compare the annual outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care: A 3-month interim analysis

The recent introduction of a home monitoring system that measures whole blood glucose and whole blood fructosamine values by fingerstick blood drop adds a previously unavailable estimate of overall glycemic control via the fructosamine component. Fructosamine serves as an indicator of overall glycemic control for a 10-14-day time frame versus the 90-day average indicated by the hemoglobin A1c (A1C) test. The utilization of the fructosamine test for management of patients with diabetes mellitus remains unclear. The primary objectives of this study are to compare the quarterly A1C results of subjects monitoring weekly fructosamine with those receiving usual care, to identify the number of patients achieving goal A1C, and to determine if the addition of a weekly fructosamine test changes a patient's quality of life. Secondary objectives include determining if specific patient demographics predict success or difficulty in achieving improved A1C. This is a prospective, randomized, multicenter controlled trial. Patients were randomly assigned to collect weekly fructosamine in addition to daily glucose (Group 1) or usual care of daily glucose (Group 2) and had study visits every 3 months. Baseline and quarterly A1C tests were collected. Quality of life assessment was conducted at baseline and will be evaluated at the final study visit. Sixty subjects have been randomized into the study since May 2001 with enrollment ongoing. Baseline demographics, glucose, fructosamine, and A1C were similar between the two groups. The 3-month interim analysis demonstrated no statistically significant difference in fructosamine (p = 0.265) between Group 1 (293.00 ± 111.22 μmol/L) and Group 2 (336.69 ± 111.12 μmol/L), respectively. No statistical difference at 3 months (p = 0.676) in A1C values for Group 1 (7.921 ± 1.848% vs. 7.755 ± 1.408%) and Group 2 (7.800 ± 1.505% vs. 7.971 ± 1.797%) were noted when compared with baseline. The interim data suggest that the fructosamine group has had a net decrease in A1C over the 3-month time frame, whereas the control group has had a net increase in A1C values. Ongoing follow-up will determine if this trend continues and becomes statistically and clinically significant.