Real-World Effectiveness and Safety of Insulin Degludec in Type 1 Diabetes

Abstract Background: India has the highest and steadily increasing burden of type 1 diabetes mellitus (T1DM) in children within South-East Asia. Effective T1DM management poses a significant challenge in the pediatric age group. Insulin degludec (IDeg) is a novel ultra-long-acting basal insulin, which has proven to be effective and safe in challenging scenarios characterized by poor glycemic control and acute complications in T1DM. Objective: This retrospective cohort study assessed the real-world effectiveness and safety of insulin IDeg in pediatric subjects with T1DM from a tertiary care center in India. Materials and Methods: The study enrolled 41 pediatric subjects with T1DM. The subjects were categorized into three cohorts (Group 1: 4–6 years; Group 2: 7–12 years; and Group 3: 13–16 years of age). A baseline assessment included demographic information, medical history, and baseline glycemic parameters. After the initiation of IDeg, glycemic and weight parameters, insulin bolus dosage, and adverse effects were evaluated at two intervals (6 and 12 months) from the baseline. Results: Of the 41 T1DM pediatric subjects, 25 (61%) were girls. Hemoglobin A1c (HbA1c) reduction from baseline to 6 months and baseline to 12 months was significant. Total bolus dose was non-significantly reduced at 12 months and baseline ( P = 0.236). Basal doses were similar throughout. There was no significant change in weight ( P = 0.434) from the baseline to sixth- and 12th-month follow-ups. The insulin injection site reactions were similar throughout. Conclusion: IDeg treatment in Indian children and adolescents with T1DM significantly reduces HbA1c without having an impact on weight or body mass index.