Effects of structured hospital-based care compared with standard care for Type 2 diabetes-The Asker and Baerum Cardiovascular Diabetes Study, a randomized trial.

AIMS

Few studies have compared structured vs. standard care on the effects of modifying several cardiovascular (CV) risk factors in subjects with Type 2 diabetes. Because of the complexity of the disease, we hypothesized that structured care with a multi-interventional approach is necessary to effectively reach treatment goals and to reduce CV risk.

METHODS

An open 2-year parallel-group study in 120 patients (age 59 +/- 10 years, 31 females) with Type 2 diabetes (median duration 4 years) was conducted. The patients were randomized to standard care (follow-up by their general practitioner) or to structured care at a hospital outpatient clinic consisting of an initial 6 months' lifestyle programme followed by targeted intensified pharmacological treatment to reach prespecified goals for glycaemic, lipid and blood pressure (BP) control. The primary outcome was change in the estimated 10-year absolute risk for fatal coronary heart disease (CHD).

RESULTS

One hundred and six patients completed the study. Improvements were greater among patients receiving structured rather than standard care for systolic BP, triglycerides, glucose and glycated haemoglobin (HbA(1c)) (P < 0.05), as well as for the estimated 10-year CHD-risk (17.9% to 14.5% vs. 18.3% to 19.6%) and the prevalence of a CHD risk >or= 20% (38% to 22% vs. 39% to 45%). Most of the reduction in estimated CHD risk (77%) in the structured care group was obtained during the period (6-24 months) with intensified pharmacological treatment (P < 0.01).

CONCLUSIONS

This study shows that 2 years of structured care combining lifestyle and pharmacological interventions improved several CV risk factors and reduced the estimated 10-year absolute risk for CHD in patients with Type 2 diabetes.