BACKGROUND: The aim of the present study was to assess the efficacy of structured education in insulin-treated type 2 diabetes mellitus (T2DM) patients. METHODS: In a 16-week open-label randomized controlled study, 1511 T2DM patients with inadequate responses to two or more oral antidiabetic drugs (OADs) for >3 months (HbA1c >7.5%) were randomized (1:1) to either an education group (structured diabetes education plus insulin therapy) or a control group (usual care plus insulin therapy). Both groups discontinued previous OADs (except biguanides and α-glucosidase inhibitors) and started twice daily injections of 30% soluble-70% isophane recombinant insulin. The primary endpoint was the change in HbA1c from baseline. Efficacy and safety data were analyzed for within- and between-group differences. RESULTS:Of the initial 1511 patients, 1289 completed the study (643 in the control group; 646 in the education group). At the end of the study, significant reductions in HbA1c versus baseline were evident in both groups, but the reduction was greater in the education group (2.16% vs. 2.08%; P < 0.05). A higher proportion of patients in the education group achieved target HbA1c levels <7% (43.81% vs. 36.86%; P < 0.05) and ≤6.5% (28.48% vs. 22.71%; P < 0.05). In addition, patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale (P < 0.05). The overall incidence of hypoglycemic events was similar in the two groups. CONCLUSIONS:Structured education can promote the ability of patients to self-manage and their compliance with medications, thereby achieving better outcomes.
RCT Entities:
BACKGROUND: The aim of the present study was to assess the efficacy of structured education in insulin-treated type 2 diabetes mellitus (T2DM) patients. METHODS: In a 16-week open-label randomized controlled study, 1511 T2DM patients with inadequate responses to two or more oral antidiabetic drugs (OADs) for >3 months (HbA1c >7.5%) were randomized (1:1) to either an education group (structured diabetes education plus insulin therapy) or a control group (usual care plus insulin therapy). Both groups discontinued previous OADs (except biguanides and α-glucosidase inhibitors) and started twice daily injections of 30% soluble-70% isophane recombinant insulin. The primary endpoint was the change in HbA1c from baseline. Efficacy and safety data were analyzed for within- and between-group differences. RESULTS: Of the initial 1511 patients, 1289 completed the study (643 in the control group; 646 in the education group). At the end of the study, significant reductions in HbA1c versus baseline were evident in both groups, but the reduction was greater in the education group (2.16% vs. 2.08%; P < 0.05). A higher proportion of patients in the education group achieved target HbA1c levels <7% (43.81% vs. 36.86%; P < 0.05) and ≤6.5% (28.48% vs. 22.71%; P < 0.05). In addition, patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale (P < 0.05). The overall incidence of hypoglycemic events was similar in the two groups. CONCLUSIONS: Structured education can promote the ability of patients to self-manage and their compliance with medications, thereby achieving better outcomes.