Efficacy and safety of closed-loop control system for type one diabetes in adolescents a meta analysis

Abstract

This meta-analysis compares the efficacy and safety of Closed-Loop Control (CLC) to Sensor-Augmented Insulin Pump (SAP) for adolescent patients with Type 1 Diabetes Mellitus (T1DM). Eleven randomized-controlled trials were included with a total of 570 patients, from a total of 869 articles found adhering to PRISMA guidelines. The efficacy of the therapies were evaluated from the day, night and during physical activities monitoring of the of the mean blood glucose (BG), Time In Range (TIR), and Standard Deviation (SD) of the glucose variability. The safety measure of the therapies, was assessed from the day and night recording of the hypoglycemic and hyperglycemic events occurred. Pooled results of comparison of mean BG values for day, night and physical activities, − 4.33 [− 6.70, − 1.96] (P = 0.0003), − 16.61 [− 31.68, − 1.54] (P = 0.03) and − 8.27 [− 19.52, 2.99] (P = 0.15). The monitoring for day, night and physical activities for TIR − 13.18 [− 19.18, − 7.17] (P < 0.0001), − 15.36 [− 26.81, − 3.92] (P = 0.009) and − 7.39 [− 17.65, 2.87] (P = 0.16). The day and night results of SD of glucose variability was − 0.40 [− 0.79, − 0.00] (P = 0.05) and − 0.86 [− 2.67, 0.95] (P = 0.35). These values shows the superiority of CLC system in terms of efficacy. The safety evaluation, of the day, night and physical activities observations of average blood glucose goal hypoglycemic events − 0.54 [− 1.86, 0.79] (P = 0.43), 0.04 [− 0.20, 0.27] (P = 0.77) and 0.00 [− 0.25, 0.25] (P = 1.00) and hyperglycemic events − 0.04 [− 0.20, 0.27] (P = 0.77), − 7.11 [− 12.77, − 1.45] (P = 0.01) and − 0.00 [− 0.10, 0.10] (P = 0.97), highlights the commendable safety factor of CLC. The CLC systems can be considered as an ideal preference in the management of adolescents with type 1 diabetes to be used during a 24 h basis.