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真实环境中 1 型糖尿病儿科人群中开源自动化胰岛素输送系统(OS-AIDs):AWeSoMe 研究组的经验。

Open-source automated insulin delivery systems (OS-AIDs) in a pediatric population with type 1 diabetes in a real-life setting: the AWeSoMe study group experience.

机构信息

Pediatric Endocrinology and Diabetes Institute, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel.

Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.

出版信息

Endocrine. 2023 Aug;81(2):262-269. doi: 10.1007/s12020-023-03398-4. Epub 2023 May 24.

Abstract

PURPOSE

The use of open-source automated insulin delivery systems (OS-AIDs), for the management of type 1 diabetes (T1D), has increased over recent years in all age groups. Real-life data has demonstrated the safety and efficacy of these systems, however, studies in the pediatric population remain limited. In this study, we aimed to examine the effect of transition to an OS-AIDs on glycemic parameters, and on several aspects related to quality of life. In addition, we aimed to characterize the socioeconomic position of families who chose this treatment modality, assess their motivations to do so, and evaluate treatment satisfaction.

METHODS

In this multi-center observational real-life study from the AWeSoMe Group, we compared glycemic parameters of 52 individuals with T1D (56% males, mean diabetes duration 4.2 ± 3.9 years), from the last clinic visit prior to OS-AIDs initiation to the most recent clinic visit while using the system. Socioeconomic position (SEP) index was retrieved from the Israel Central Bureau of Statistics. Caregivers completed questionnaires assessing reasons for system initiation and treatment satisfaction.

RESULTS

Mean age at OS-AIDs initiation was 11.2 ± 4 years, range 3.3-20.7 years with a median usage duration of 11.1 months (range 3-45.7). Mean SEP Index was 1.033 ± 0.956 (value range: -2.797 to 2.590). Time in range (TIR) of 70 to 180 mg/dl increased from 69.0 ± 11.9 to 75.5 ± 11.7%, (P < 0.001), and HbA1c decreased from 6.9 ± 0.7 to 6.4 ± 0.6%, (P < 0.001). Time in tight range (TITR) of 70 to 140 mg/dl increased from 49.7 ± 12.9 to 58.8 ± 10.8% (P < 0.001). No episodes of severe hypoglycemia or DKA were reported. Reduction in diabetes burden and sleep quality improvement were the main reasons for OS-AID initiation.

CONCLUSIONS

In our cohort of youth with T1D, the transition to an OS-AID resulted in greater TIR and less severe hypoglycemia regardless of age, diabetes duration or SEP, which was found to be above average. The overall improvement in glycemic parameters in our study population with excellent baseline glycemic control, provides additional evidence of beneficence and efficacy of OS-AIDs in the pediatric population.

摘要

目的

近年来,各种开源自动化胰岛素输注系统(OS-AIDs)在各年龄段 1 型糖尿病(T1D)患者中的应用日益增多。真实世界的数据已经证明了这些系统的安全性和有效性,但儿科人群的研究仍然有限。在这项研究中,我们旨在研究过渡到 OS-AIDs 对血糖参数以及生活质量相关的几个方面的影响。此外,我们旨在描述选择这种治疗方式的家庭的社会经济地位,评估他们选择这种治疗方式的动机,并评估治疗满意度。

方法

在 AWeSoMe 小组的这项多中心观察性真实世界研究中,我们比较了 52 名 T1D 患者(男性占 56%,平均糖尿病病程 4.2±3.9 年)的血糖参数,这些患者在使用 OS-AIDs 前的最后一次就诊和使用 OS-AIDs 后的最近一次就诊时的血糖参数。从以色列中央统计局检索社会经济地位(SEP)指数。护理人员完成了评估系统启动原因和治疗满意度的问卷。

结果

OS-AIDs 起始时的平均年龄为 11.2±4 岁,范围为 3.3-20.7 岁,中位使用时间为 11.1 个月(范围 3-45.7)。平均 SEP 指数为 1.033±0.956(数值范围:-2.797 至 2.590)。70-180mg/dl 的时间在目标范围内(TIR)从 69.0±11.9%增加到 75.5±11.7%(P<0.001),HbA1c 从 6.9±0.7%降低到 6.4±0.6%(P<0.001)。70-140mg/dl 的时间在严格目标范围内(TITR)从 49.7±12.9%增加到 58.8±10.8%(P<0.001)。没有报告严重低血糖或 DKA 发作。减少糖尿病负担和改善睡眠质量是启动 OS-AID 的主要原因。

结论

在我们的 T1D 青少年队列中,无论年龄、糖尿病病程或 SEP 如何,过渡到 OS-AID 都会导致 TIR 增加和严重低血糖减少,而我们的 SEP 被发现处于平均水平之上。在我们的研究人群中,血糖参数的整体改善,血糖控制良好,为 OS-AIDs 在儿科人群中的有益性和有效性提供了额外的证据。

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