Program of Postgraduate Studies Adolescent Medicine and Adolescent Health Care, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, 54124, Greece; Department of Pediatrics, Gennimatas General Hospital of Thessaloniki, Thessaloniki 54635, Greece.
4th Department of Pediatrics, Papageorgiou General Hospital, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, 56429, Greece.
Diabetes Res Clin Pract. 2023 May;199:110678. doi: 10.1016/j.diabres.2023.110678. Epub 2023 Apr 23.
Insulin administration is the treatment of choice for people with type 1 diabetes mellitus (T1D). Technological advances have led to the development of automated insulin delivery (AID) systems, aiming to optimize the quality of life of patients with T1D. We present a systematic review and meta-analysis of the current literature about the efficacy of AID systems in children and adolescents with T1D.
We conducted a systematic literature search for randomized controlled trials (RCTs) until August 8th, 2022, investigating the efficacy of AID systems in the management of patients < 21 years of age with T1D. A priori subgroup and sensitivity analyses based on different settings (free-living settings, type of AID system, parallel group or crossover design) were also conducted.
In total, 26 RCTs reporting a total of 915 children and adolescents with T1D were included in the meta-analysis. AID systems revealed statistically significant differences in the main outcomes, such as the proportion of time in the target glucose range (3.9-10 mmol/L) (p < 0.00001), in hypoglycemia (<3.9 mmol/L) (p = 0.003) and mean proportion of HbA1C (p = 0.0007) compared to control group.
According to the present meta-analysis, AID systems are superior to insulin pump therapy, sensor-augmented pumps and multiple daily insulin injections. Most of the included studies have a high risk of bias because of allocation, blinding of patients and blinding of assessment. Our sensitivity analyses showed that patients < 21 years of age with T1D can use AID systems, after proper education, following their daily activities. Further RCTs examining the effect of AID systems on nocturnal hypoglycemia, under free-living settings and studies examining the effect of dual-hormone AID systems are pending.
胰岛素给药是 1 型糖尿病(T1D)患者的首选治疗方法。技术进步带来了自动化胰岛素输注(AID)系统的发展,旨在优化 T1D 患者的生活质量。我们对当前关于 AID 系统在 T1D 儿童和青少年中的疗效的文献进行了系统评价和荟萃分析。
我们对截至 2022 年 8 月 8 日的随机对照试验(RCT)进行了系统文献检索,以调查 AID 系统在管理年龄<21 岁的 T1D 患者中的疗效。还根据不同的设置(自由生活设置、AID 系统类型、平行组或交叉设计)进行了预先设定的亚组和敏感性分析。
共有 26 项 RCT 报告了 915 名 T1D 儿童和青少年的总数据,纳入荟萃分析。AID 系统在主要结局方面显示出统计学上的显著差异,例如目标血糖范围内的时间比例(3.9-10mmol/L)(p<0.00001)、低血糖(<3.9mmol/L)(p=0.003)和平均 HbA1C 比例(p=0.0007)与对照组相比。
根据本荟萃分析,AID 系统优于胰岛素泵治疗、传感器增强泵和多次每日胰岛素注射。由于分配、患者和评估的盲目性,大多数纳入的研究存在高偏倚风险。我们的敏感性分析表明,经过适当的教育,T1D 年龄<21 岁的患者可以在日常活动后使用 AID 系统。正在等待进一步的 RCT 来检查 AID 系统对自由生活环境下的夜间低血糖以及双激素 AID 系统的影响。