Study design
Approval for the conduction of the study was granted by the Ethics committee of the South West Regional Health Authority. Patients who fulfilled the inclusion and exclusion criteria were randomly allocated to either the control group or an intervention group. Over 48 weeks, subjects within the control group continued to receive routine care; subjects within the intervention group were treated with stage-specific, personalised care for Type 2 diabetes using the Stages of Change model. To ensure concealment of allocation, an independently designed randomisation schedule using a table of random numbers was created with sealed consecutively numbered opaque envelopes. Each envelope contained a card indicating either "Intervention" or "Control". See Figure Figure11.