1型糖尿病幼儿AHCL系统安全性和有效性的真实世界评估：为期1年的评估
Real-world evaluation of safety and efficacy of AHCL systems in young children with type 1 diabetes: a 1-year assessment.
作者信息
Franzone Daniele, Spacco Giordano, Piano Andrea, Siri Giulia, Tantari Giacomo, d'Annunzio Giuseppe, Calevo Maria Grazia, Maghnie Mohamad, Minuto Nicola, Bassi Marta
机构信息
DINOGMI (Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health), University of Genoa, Genoa, Italy.
Department of Pediatrics and Neonatology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Giannina Gaslini, Savona, Italy.
出版信息
Front Endocrinol (Lausanne). 2025 Jun 26;16:1590964. doi: 10.3389/fendo.2025.1590964. eCollection 2025.
BACKGROUND AND AIMS
Management of Type 1 Diabetes (T1D) in young children is challenging. A poor glycaemic control during the first years of disease increases the risk of microvascular complications. Moreover, hyperglycaemia and glucose variability have a negative effect on the brain development. Advanced hybrid closed loop (AHCL) systems demonstrated to improve glycaemic control in adolescents and adults with T1D although data on younger children are limited. The aim of the study was to evaluate the safety and the effectiveness of AHCL systems' off-label use in children aged less than 7 years.
METHODS
A retrospective single-center study on T1D patients aged less than 7 years using AHCL systems was conducted. Glycated hemoglobin (HbA1c) values, Continuous Glucose Monitoring (CGM) and insulin requirement data were collected at T0 (AHCL starting), T1 (1-month), T2 (3-months) and T3 (1-year).
RESULTS
41 patients were included in the study. No episode of severe hypoglycaemia occurred. Three patients experienced an episode of ketoacidosis (DKA) due to insulin delivery set occlusion. During the 12-months study period, an improvement in HbA1c value (7.50 6.59%, p<0.001), Time in Range (TIR, +10.21%, p<0.001) and Time in Tight Range (TITR, +7.56%, p=0.003) were observed, with a reduction in time in hyperglycaemia and without an increase in time in hypoglycaemia. The AHCL use increased insulin requirement at 12-months, especially in bolus doses (p<0.001).
CONCLUSIONS
Although AHCL systems are not currently approved for this age group, we have demonstrated their safety and efficacy in children under 7 years with T1D. The use of these systems resulted in significant improvement in glycaemic control without increasing the risk of hypoglycaemia. The impact of early glycaemic control on brain development during the first years of life may support the early introduction of AHCL systems in very young children with T1D. It is essential to gather data that could support the approval of these systems for use in younger age groups.
背景与目的
幼儿1型糖尿病（T1D）的管理具有挑战性。疾病最初几年血糖控制不佳会增加微血管并发症的风险。此外，高血糖和血糖变异性对大脑发育有负面影响。先进的混合闭环（AHCL）系统已证明可改善青少年和成人T1D患者的血糖控制，不过关于年幼儿童的数据有限。本研究的目的是评估AHCL系统在7岁以下儿童中标签外使用的安全性和有效性。
方法
对使用AHCL系统的7岁以下T1D患者进行了一项回顾性单中心研究。在T0（开始使用AHCL时）、T1（1个月）、T2（3个月）和T3（1年）收集糖化血红蛋白（HbA1c）值、持续葡萄糖监测（CGM）和胰岛素需求数据。
结果
41名患者纳入研究。未发生严重低血糖事件。3名患者因胰岛素输注装置堵塞发生了酮症酸中毒（DKA）事件。在12个月的研究期间，观察到HbA1c值有所改善（从7.50降至6.59%，p<0.001）、血糖达标时间（TIR，增加10.21%，p<0.001）和严格血糖达标时间（TITR，增加7.56%，p=0.003），同时高血糖时间减少且低血糖时间未增加。使用AHCL系统在12个月时增加了胰岛素需求，尤其是大剂量胰岛素（p<0.001）。
结论
尽管AHCL系统目前未被批准用于该年龄组，但我们已证明其在7岁以下T1D儿童中的安全性和有效性。使用这些系统可显著改善血糖控制且不增加低血糖风险。生命最初几年早期血糖控制对大脑发育的影响可能支持在非常年幼的T1D儿童中早期引入AHCL系统。收集能够支持批准这些系统用于更年轻年龄组的数据至关重要。
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