Abstract

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.

Notes

Acknowledgments

This study was supported by grants from the Health Ministry of Spain (Fondos de Cohesion 2008) and the Fundación para Estudios Endocrinometabólicos. LdV was supported by a grant from the Health Ministry and the Fundación para Estudios Endocrinometabólicos.