Benefits of self-monitoring blood glucose in the management of new-onset Type 2 diabetes mellitus: The St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups

Background: Intensive treatment of patients with Type 2 diabetes mellitus (T2DM) from the moment of diagnosis facilitates beta-cell recovery. Self-monitoring of blood glucose (SMBG)-based educational and pharmacological intervention may be better than conventional HbA1c algorithms in the treatment of newly diagnosed T2DM. Methods: Newly diagnosed T2DM patients were randomized to either an SMBG-based intervention or an HbA1c-based control group (n = 99 and 62, respectively) and were followed for 1 year. Results: Higher rates of diabetes regression (HbA1c < 6% on metformin alone) and remission (HbA1c between 6.0% and 6.4%) were achieved in the intervention compared with the control group (39% vs 5% (P < 0.001) and 37% vs 30% (P < 0.01), respectively). Furthermore, significantly greater reductions in median HbA1c (6.6% to 6.1%; P < 0.05) and body mass index (29.6-27.9 kg/m(2); P < 0.001) were seen in the intervention over the 1 year of therapy. The percentage of patients achieving a lifestyle score > 12 was significantly greater in the SMBG compared with the control group (38.4% vs 9.7% respectively; P < 0.001). An inverse correlation was observed between SMBG and HbA1c levels (P < 0.04). Conclusions: The results indicate that SMBG-based structured educational and pharmacological programs empower patients to achieve nutritional and physical activity goals, and encourage physicians and patients to use SMBG to optimize therapy. We believe that the concept of intensive treatment of T2DM patients should be modified; instead of referring to the type of treatment (insulin use), the term should reflect the intensity with which we work to reach glucose objectives.