title: 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.
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.
authors.affiliation: Endocrinology and Nutrition Department, Hospital Clinico San Carlos-IdISSC, Professor Martin Lagos s/n, 1ª Sur., 28040, Madrid, Spain, nurialobo@hotmail.com.
authors.forename: Nuria
authors.initials: N
authors.lastname: García de la Torre
authors.forename: Alejandra
authors.initials: A
authors.lastname: Durán
authors.forename: Laura
authors.initials: L
authors.lastname: Del Valle
authors.forename: Manuel
authors.initials: M
authors.lastname: Fuentes
authors.forename: Idoya
authors.initials: I
authors.lastname: Barca
authors.forename: Patricia
authors.initials: P
authors.lastname: Martín
authors.forename: Carmen
authors.initials: C
authors.lastname: Montañez
authors.forename: Natalia
authors.initials: N
authors.lastname: Perez-Ferre
authors.forename: Rosario
authors.initials: R
authors.lastname: Abad
authors.forename: Fuencisla
authors.initials: F
authors.lastname: Sanz
authors.forename: Mercedes
authors.initials: M
authors.lastname: Galindo
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Rubio
authors.forename: Alfonso L
authors.initials: AL
authors.lastname: Calle-Pascual
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D008019:Life Style; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin