Early management of type 2 diabetes based on a SMBG strategy: the way to diabetes regression--the St Carlos study : a 3-year, prospective, randomized, clinic-based, interventional study with parallel groups.

The aims are to define the regression rate in newly diagnosed type 2 diabetes after lifestyle intervention and pharmacological therapy based on a SMBG (self-monitoring of blood glucose) strategy in routine practice as compared to standard HbA1c-based treatment and to assess whether a supervised exercise program has additional effects. St Carlos study is a 3-year, prospective, randomized, clinic-based, interventional study with three parallel groups. Hundred and ninety-five patients were randomized to the SMBG intervention group [I group; n = 130; Ia: SMBG (n = 65) and Ib: SMBG + supervised exercise (n = 65)] and to the HbA1c control group (C group) (n = 65). The primary outcome was to estimate the regression rate of type 2 diabetes (HbA1c <6 % on metformin treatment). After 3 years of follow-up, diabetes regression was achieved by 56 patients, 6 (9.2 %) from the C group, 21 (32.3 %) from the Ia group and 29 (44.6 %) from the Ib group. RR (95 % CI) for diabetes regression in the intervention group (Ia + Ib) was 4.5 (2.1-9); p < 0.001 and remained after stratification by gender, age and BMI. This difference was associated with healthier changes in lifestyle and greater weight loss. RR for a weight loss >4 kg was 3.6 (1.8-7); p < 0.001. This study shows that the use of SMBG in an educational program effectively increases the regression rate in newly diagnosed type 2 diabetic patients after 3 years of follow-up. These data suggest that SMBG-based programs should be extended to primary care settings where diabetic patients are usually attended.

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 ß-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.