Department of Pediatrics, Imam Mohammed Ibn Saud Islamic University, An Nada, 13317, Riyadh, Saudi Arabia.
Sci Rep. 2023 Aug 13;13(1):13165. doi: 10.1038/s41598-023-40423-y.
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.
这项荟萃分析比较了闭环控制（CLC）与传感器增强型胰岛素泵（SAP）在 1 型糖尿病青少年患者中的疗效和安全性。共有 11 项随机对照试验纳入了总共 570 名患者，共有 869 篇文章符合 PRISMA 指南。通过监测平均血糖（BG）、时间在范围内（TIR）和血糖变异性的标准差（SD），评估治疗的疗效。通过记录白天和夜间发生的低血糖和高血糖事件，评估治疗的安全性。比较日间、夜间和体力活动时平均 BG 值的汇总结果为：-4.33 [-6.70, -1.96]（P = 0.0003）、-16.61 [-31.68, -1.54]（P = 0.03）和-8.27 [-19.52, 2.99]（P = 0.15）。监测日间、夜间和体力活动时的 TIR 为-13.18 [-19.18, -7.17]（P < 0.0001）、-15.36 [-26.81, -3.92]（P = 0.009）和-7.39 [-17.65, 2.87]（P = 0.16）。血糖变异性 SD 的日间和夜间结果为-0.40 [-0.79, -0.00]（P = 0.05）和-0.86 [-2.67, 0.95]（P = 0.35）。这些值表明 CLC 系统在疗效方面具有优越性。对白天、夜间和体力活动观察平均血糖目标低血糖事件的安全性评估为-0.54 [-1.86, 0.79]（P = 0.43）、0.04 [-0.20, 0.27]（P = 0.77）和 0.00 [-0.25, 0.25]（P = 1.00）和高血糖事件为 0.00 [-0.20, 0.27]（P = 0.77）、-7.11 [-12.77, -1.45]（P = 0.01）和-0.00 [-0.10, 0.10]（P = 0.97），突出了 CLC 的良好安全性。CLC 系统可被视为在 24 小时基础上管理 1 型糖尿病青少年患者的理想选择。
