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

Abstract

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.