A Randomized controlled trial to assess the effectiveness of group-based Diabetes Self-Management Education (DSME) program on glycemic control and self-care activities among type-2 diabetics in South-East Delhi

ABSTRACT

Introduction: India has the second-largest population of diabetes globally. The long-term complications due to poor glycemic control are concerning. Diabetes Self-Management Education (DSME) is a fundamental component in managing diabetes better. Objectives: This study was conducted to compare the effectiveness of group-based DSME in achieving glycemic control and improving self-care practices among people with type-2 diabetes as against the usual care. Methods: A nonblinded parallel-arm RCT among adults (? 30 years) diagnosed with Type-2 DM. Written informed consent was taken from each patient before enrollment. The sample size is estimated to be 85 in each arm according to the formula for equivalence design for an RCT. Randomization was done using a computer-generated random number table. The control arm received usual care, while the intervention group received group-based DSME in addition to usual care. At the end of 6 months, the change in glycemic control and self-care activity scores were compared between the two arms. Results: A total of 139 individuals (intervention =69; control =70) were analyzed. The proportion of females (62.1%) was higher than males (37.9%). There was no statistically significant difference at baseline. At end line, HbA1c showed a reduction from 9.3% to 6.9% in the intervention arm (P<0.001), which was greater than that in the control arm (p=0.017). All the self-care components showed a statistically significant improvement, except the medication score. Conclusions: Group-based DSME effectively increases self-care practices among people with diabetes, resulting in better glycemic control.