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商业混合闭环系统应用于 111 例 1 型糖尿病儿童和青少年的首年经验。

First year on commercial hybrid closed-loop system-experience on 111 children and adolescents with type 1 diabetes.

机构信息

Children's Hospital, Pediatric Research Center, Helsinki University Hospital, and University of Helsinki, Helsinki, Finland.

出版信息

Pediatr Diabetes. 2021 Sep;22(6):909-915. doi: 10.1111/pedi.13235. Epub 2021 May 28.

Abstract

OBJECTIVE

The hybrid close-loop system (HCL) is a rapidly emerging treatment method for type 1 diabetes (T1D), but the long-term effectiveness of the system remains unclear. This study investigates the influence of the HCL on glycemic control in children and adolescents with T1D in a real-life setting during the first year on HCL.

RESEARCH DESIGN AND METHODS

This retrospective study included all the patients (n = 111) aged 3 to 16 years with T1D who initiated the HCL system between 1st of December 2018 and 1st of December 2019 in the Helsinki University Hospital. Time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR), and SG coefficient of variance (CV) were measured at 0, 1, 3, 6, and 12 month. The changes over time were analyzed with a repeated mixed model adjusted with baseline glycemic control.

RESULTS

After the initiation of HCL, all measures of glycemic control, except HbA1c, improved and the effect lasted throughout the study period. Between 0 and 12 month, TIR increased (β = -2.5 [95%CI: -3.6 - (-1.3)], p < 0.001), whereas mean SG values (β = -0.7 [95%CI: -0.9 - (-0.4)]), TBR (β = -2.5 [95%CI: -3.6 - (-1.3)]), and SG CV (β = -4.5 [95%CI: -6.3 - [-2.8]) decreased significantly (p < 0.001). Importantly, the changes occurred regardless of the age of the patient.

CONCLUSIONS

Measurements of glycemic control, except HbA1c, improved significantly after the initiation of the HCL system and the favorable effect lasted throughout the follow-up. These results support the view that HCL is an efficacious treatment modality for children and adolescents with T1D of all ages.

摘要

目的

混合闭环系统(HCL)是一种治疗 1 型糖尿病(T1D)的新兴方法,但该系统的长期疗效尚不清楚。本研究旨在探讨 HCL 对儿童和青少年 T1D 患者在 HCL 应用的第一年中的血糖控制的影响。

研究设计和方法

本回顾性研究纳入了 2018 年 12 月 1 日至 2019 年 12 月 1 日期间在赫尔辛基大学医院接受 HCL 系统治疗的所有 3 至 16 岁 T1D 患者(n=111)。在 0、1、3、6 和 12 个月时测量时间在目标范围内(TIR)、HbA1c、平均传感器血糖(SG)值、低于目标范围的时间(TBR)和 SG 变异系数(CV)。采用重复混合模型分析调整基线血糖控制后随时间的变化。

结果

在启动 HCL 后,除 HbA1c 外,所有血糖控制指标均得到改善,并且这种效果持续整个研究期间。在 0 至 12 个月期间,TIR 增加(β=-2.5[95%CI:-3.6-(-1.3)],p<0.001),而平均 SG 值(β=-0.7[95%CI:-0.9-(-0.4)),TBR(β=-2.5[95%CI:-3.6-(-1.3)])和 SG CV(β=-4.5[95%CI:-6.3-(-2.8])显著降低(p<0.001)。重要的是,这些变化与患者的年龄无关。

结论

在启动 HCL 系统后,血糖控制的测量值(除 HbA1c 外)显著改善,并且这种有利影响持续整个随访期间。这些结果支持 HCL 是一种治疗所有年龄段 T1D 儿童和青少年的有效治疗方法的观点。

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