Efficacy and Safety of a Decision Support Intervention for Basal Insulin Self-Titration Assisted by the Nurse in Outpatients with T2DM: A Randomized Controlled Trial

OBJECTIVE: The main aim of this study was to evaluate a combined fasting blood glucose based dosage self-titration setting and decision supported telephone coaching intervention on glycemic control and diabetes self-management skills, compared to the conventional care. METHODS: A 12-week, single-blinded, randomized controlled trial was conducted on adults with type 2 diabetes (T2DM) primarily treated with basal insulin. After randomization, the intervention group (IG, n = 426) received a basal insulin self-titration decision support intervention administered by the Diabetes Specialty Nurses while the control group (CG, n = 423) received conventional care for 12 weeks, both included five telephone interviews. The primary efficacy endpoint was the effect of intervention on glycemic control, measured as the change in glycated hemoglobin (HbA1c) from baseline to Week 12 (after intervention) compared to the control group. Other endpoints included comparisons of the effects of intervention on fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body weight, Michigan diabetes knowledge test (MDKT), diabetes empowerment scale-short Form (DES-DSF), and summary of diabetes self-care activities (SDSCA). Changes in the primary and secondary outcomes were compared using the t-test for continuous variables with a normal distribution and χ(2)-test for categorical variables. RESULTS: The IG showed more improvements on mean HbA1c, compared to the CG (−2.8% vs −1.8%), so did the FPG, PPG, MDKT, DES-DSF and SDSCA (all P<0.01) after the 12-week follow up. Though the final mean insulin dose in the IG was higher than the CG at the end of the study (0.32 U/kg vs 0.28 U/kg), the changes of body weight were similar between the two groups (0.46kg vs 0.40kg, P=0.246), and the proportion of patients with hypoglycemia events during the whole trial were similar (20.65% vs 17.73%, P=0.279). CONCLUSION: Decision supporting of basal insulin glargine self-titration assisted by Diabetes Specialty Nurses is effective and safe in patients with T2DM. Decision supported telephone coaching intervention offers ongoing encouragement, guidance, and determination of relevant sources of decisional conflict, facilitating adjusting the insulin dose.