Translational research for Diabetes Self-Management in Sri Lanka: A randomized controlled trial.

AIMS: The study tested the hypothesis that a theory driven Diabetes Self-Management (DSM) intervention delivered by trained nurses would result in a clinically significant improvement in glycaemic control. METHODS: Patients with an HbA1c >7.5% (58mmol/mol) and free of diabetes complications were enrolled into a randomized controlled trial (n=85). Intervention consisted of four sessions and monthly follow up for 6 months. Biochemical tests, and diet and physical activity assessments were done in both groups. Analysis of covariance was used to test the effectiveness of the intervention. RESULTS: At 6 months, there was a significant difference (P=0.001) in HbA1c between the groups controlling for baseline values and other variables. Based on the primary outcome, 28% in the intervention group achieved the target value of 6.5% HbA1c, compared to 8% in the "usual care" group (P<0.001; η(2)=0.65). The reduction in total energy intake and increase in physical activity was significant in the intervention group between baseline and follow up. CONCLUSIONS: The DSM intervention has resulted in a clinically significant impact on glycaemia, change in diet and physical activity, and has demonstrated the feasibility of using it within existing care arrangements in a developing country setting.