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

• Published in: Acta diabetologica Vol. 50; no. 4; pp. 607 - 614
• Main Authors: García de la Torre, Nuria, Durán, Alejandra, del Valle, Laura, Fuentes, Manuel, Barca, Idoya, Martín, Patricia, Montañez, Carmen, Perez-Ferre, Natalia, Abad, Rosario, Sanz, Fuencisla, Galindo, Mercedes, Rubio, Miguel A., Calle-Pascual, Alfonso L.
• Format: Journal Article
• Language: English
• Published: Milan Springer Milan 01-08-2013; Springer Nature B.V
• Subjects: Aged; Blood Glucose - analysis; Blood Glucose Self-Monitoring; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Disease management; Drug use; Female; Glycated Hemoglobin A - analysis; Health behavior; Humans; Hypoglycemic Agents - administration & dosage; Internal Medicine; Life Style; Male; Medicine; Medicine & Public Health; Metabolic Diseases; Metformin - therapeutic use; Middle Aged; Original Article; Prospective Studies; Regression; SMBG (self-monitoring of blood glucose); Exercise
• ISSN: 0940-5429; 1432-5233
• DOI: 10.1007/s00592-013-0467-9

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.