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

Acta Diabetol. 2013 Aug;50(4):607-14. doi: 10.1007/s00592-013-0467-9. Epub 2013 Mar 27.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Blood Glucose / analysis
  • Blood Glucose Self-Monitoring*
  • Diabetes Mellitus, Type 2 / blood*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Female
  • Glycated Hemoglobin A / analysis
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Life Style
  • Male
  • Metformin / therapeutic use
  • Middle Aged
  • Prospective Studies


  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Metformin