1080-P: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing Patient Satisfaction and Compliance with a Needle-Free Insulin Injector vs. Conventional Insulin Pen Injections in Chinese Patients with Type 2 Diabetes Mellitus

Abstract

Background: The proportion of patients with type 2 diabetes (T2DM) using insulin is still very low and often is initiated relatively late. The needle-free insulin injector is designed for diabetic patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. Objective: To evaluate patient satisfaction and compliance with a needle-free insulin injector versus conventional insulin pen injections in patients with T2DM treated for 16 weeks. Methods: A total of 427 patients with T2DM were enrolled in a multicenter, prospective, randomized, open-label study, and were randomized 1:1 to receive basal insulin or premixed insulin via a needle-free injector or via conventional insulin pen injections. Patients’ quality-of-life (determined by the SF-36 questionnaire), the insulin dose administered, compliance with insulin therapy (as evaluated by missing injections), and patients’ satisfaction with their injection device (scored on a scale of 0 to 10) were evaluated. Results: In the 412 patients who completed the study, mean SF-36 questionnaire scores were increased significantly in both the needle-free injector and conventional insulin pen groups (123.21 ± 16.64 vs. 122.11 ± 16.82, respectively), with no significant difference between the 2 groups. There was also no significant difference between the groups in compliance. However, subjects in the needle-free injector group showed significantly higher treatment satisfaction scores than those in the conventional insulin pen group after 16 weeks of treatment (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; P < 0.0001). Conclusions: The needle-free injector improved the quality-of-life of T2DM patients and significantly enhanced their satisfaction with insulin treatment compared with conventional insulin pen injections. Disclosure Y. Wang: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. L. Guo: None. X. Ran: None. L. Chen: Research Support; Self; Becton, Dickinson and Company. Z. Ma: None. Z. Sun: None. Z. Shan: None. X. Xu: None. G. Wang: None.