Glycemic control metrics during exercise in children with type 1 diabetes treated with domestic insulin aspart biosimilars using a hybrid closed-loop system

Introduction . Achieving and maintaining target glycemic levels in children and adolescents with type 1 diabetes (T1D) remains a challenging task, especially during physical activity, which significantly increases the risk of acute complications. This study evaluated metabolic control parameters in children and adolescents engaged in regular sports activities and receiving therapy with domestic biosimilars of insulin aspart under the conditions of a hybrid closed-loop (HCL) systems. Aim . To evaluate the efficacy and safety of domestic insulin aspart biosimilars in HCL systems in physically active children with T1D. Materials and methods . A retrospective comparative study was conducted involving 36 children and adolescents with T1D treated using HCL systems and regularly engaged in sports. Study participants received therapy with the insulin aspart biosimilars RinFastNic (n = 17) and RinFast (n = 19). The observation period was 12 weeks. Key glycemic control metrics (TIR, TAR, TBR, CV, HbA1c) were assessed based on continuous glucose monitoring data. Results . The RinFastNic group demonstrated statistically superior metabolic control metrics compared to the RinFast group: Time in Range (TIR) was 81.41% vs. 67.74% (p < 0.05), Time Above Range (TAR) – 13.18% vs. 28.53% (p < 0.05). Hypoglycemia metrics (TBR) were comparable. Сoefficient of variation (33.01% vs. 38.46%, p < 0.05) and HbA1c level (6.4% vs. 6.8%, p < 0.05) were also better in the main group. Conclusions . The use of the insulin aspart biosimilar RinFastNic in HCL systems is associated with a significant improvement in glycemic control in physically active children with T1D, primarily due to increased TIR and reduced hyperglycemia, without an increased risk of hypoglycemia. The results indicate the importance of considering the pharmacokinetic properties of insulin for optimizing HCL system performance under conditions of physical activity.