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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

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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.

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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.

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Authors and Affiliations

  1. Endocrinology and Nutrition Department, Hospital Clinico San Carlos-IdISSC, Professor Martin Lagos s/n, 1ª Sur., 28040, Madrid, Spain

    Nuria García de la Torre, Alejandra Durán, Laura del Valle, Patricia Martín, Carmen Montañez, Natalia Perez-Ferre, Rosario Abad, Fuencisla Sanz, Mercedes Galindo, Miguel A. Rubio & Alfonso L. Calle-Pascual

  2. Preventive Medicine Department, Hospital Clínico San Carlos-IdISSC, Madrid, Spain

    Manuel Fuentes

  3. Rehabilitation Service, Hospital Clínico San Carlos-IdISSC, Madrid, Spain

    Idoya Barca

Authors
  1. Nuria García de la Torre
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  2. Alejandra Durán
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  3. Laura del Valle
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  4. Manuel Fuentes
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  5. Idoya Barca
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  6. Patricia Martín
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  7. Carmen Montañez
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  8. Natalia Perez-Ferre
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  9. Rosario Abad
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  10. Fuencisla Sanz
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  11. Mercedes Galindo
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  12. Miguel A. Rubio
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  13. Alfonso L. Calle-Pascual
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Corresponding author

Correspondence to Nuria García de la Torre.

Additional information

Communicated by Massimo Federici.

Clinical Trial Number ISRCTN81672669 (available at http://www.controlled-trial.com/ISRCTN81672669 (Accessed November 18th, 2012).

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García de la Torre, N., Durán, A., del Valle, L. et al. Early management of type 2 diabetes based on a SMBG strategy: the way to diabetes regression—the St Carlos study. Acta Diabetol 50, 607–614 (2013). https://doi.org/10.1007/s00592-013-0467-9

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  • DOI: https://doi.org/10.1007/s00592-013-0467-9

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