Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, UMC - University Children's Hospital, Ljubljana, Slovenia.
Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Expert Opin Drug Deliv. 2020 Feb;17(2):157-166. doi: 10.1080/17425247.2020.1713747.
: Optimal glycemic control remains challenging in children and adolescents with type 1 diabetes due to highly variable day-to-day and night-to-night insulin requirements. This hurdle could be addressed by glucose-responsive insulin delivery based on real-time continuous glucose measurements.: This review summaries recent advances of closed-loop systems in children and adolescents with type 1 diabetes, using both single- and dual-hormone closed-loop systems. The main outcomes, proportions of time spent in target range 70-180 mg/dl, and time spent in hypoglycemia below 70 mg/dl, are assessed particularly during unsupervised free-living randomized controlled trials.: Noteworthy and clinically meaningful translation of experimental investigations from controlled in-hospital settings to unrestricted home studies have been achieved over the past years, resulting in the regulatory approval of the first hybrid closed-loop system also in the pediatric population and with several other advanced devices in the pipeline. Large multinational and pivotal clinical trials including broad age populations are underway to facilitate the use of closed-loop systems in routine clinical practice.
: 由于 1 型糖尿病儿童和青少年的胰岛素需求在每天和每晚之间变化很大，因此实现最佳血糖控制仍然具有挑战性。通过基于实时连续血糖测量的葡萄糖反应性胰岛素输送，可以解决这一难题。: 本文综述了使用单激素和双激素闭环系统的 1 型糖尿病儿童和青少年闭环系统的最新进展。主要评估指标为目标范围 70-180mg/dl 内的时间比例和血糖低于 70mg/dl 的时间比例，特别是在非监督自由生活的随机对照试验期间。: 在过去几年中，从受控的住院环境到不受限制的家庭研究，实验研究取得了显著且具有临床意义的转化，这导致了首个混合闭环系统也在儿科人群中获得监管批准，还有其他几个先进的设备也在研发中。正在进行大型的多国和关键临床试验，包括广泛的年龄人群，以促进闭环系统在常规临床实践中的应用。
