Meal-related structured self-monitoring of blood glucose: effect on diabetes control in non-insulin-treated type 2 diabetic patients.

OBJECTIVE To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients. RESEARCH DESIGN AND METHODS This 6-month study, which included 6 months of follow-up, adopted a prospective, multicenter, randomized controlled design. Subjects were randomized to two groups: one group used a blood glucose-monitoring device, kept a blood glucose/eating diary, and received standardized counseling; the control group received nonstandardized counseling on diet and lifestyle. The primary efficacy parameter was the change in HbA(1c). Secondary efficacy variables included changes in body weight, lipids, and microalbumin and changes in treatment satisfaction and well-being. RESULTS In the per-protocol analysis, the use of a self-monitoring blood glucose device significantly reduced HbA(1c) levels by 1.0 +/- 1.08% compared with 0.54 +/- 1.41% for the control group (P = 0.0086); subgroup analysis showed three types of responders. Body weight, total cholesterol, and microalbumin improved when using a glucometer, but there was no statistically significant difference between the two groups. Treatment satisfaction increased in both groups to a similar extent (P = 0.9). Self-monitoring resulted in a marked improvement of general well-being with significant improvements in the subitems depression (P = 0.032) and lack of well-being (P = 0.02). CONCLUSIONS Meal-related self-monitoring of blood glucose within a structured counseling program improved glycemic control in the majority of non-insulin-treated type 2 diabetic patients in this study. The finding of three types of responders will be important for future planning of counseling and educational interventions.