Real-world efficacy and safety of open-source automated insulin delivery for people with type 1 diabetes mellitus: Experience from mainland China.

IF 6.1 3区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes research and clinical practice Pub Date : 2024-10-29 DOI:10.1016/j.diabres.2024.111910

Yongwen Zhou, Mengyun Lei, Daizhi Yang, Ping Ling, Ying Ni, Hongrong Deng, Wen Xu, Xubin Yang, Jinhua Yan, Benjamin John Wheeler, Jianping Weng

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Abstract

Background: Open-source automated insulin delivery systems are increasingly adopted yet predominantly discussed outside of Asia. This study aimed to describe efficacy and safety of android artificial pancreas (AAPS) in people with type 1 diabetes mellitus (T1DM) from mainland China.

Methods: This real-world study recruited people who initiated AAPS for ≥ 3 months between 2019 and 2024. Key outcomes included glycated hemoglobin A1c (HbA1c) and metrics from continuous glucose monitoring, rates of diabetic ketoacidosis (DKA) and severe hypoglycemia.

Findings: 292 (male, 46·9 %) participants aged 25·7 (14·7, 35·0) years were included, with 183 (62·7 %) and 68 (23·3 %) using AAPS for 6 and 12 months. Prior-AAPS HbA1c was 7·6 ± 1·7 % with 44·5 % achieving < 7·0 %. After 3 months, mean HbA1c improved by -1·5 ± 2·0 % to 6·3 ± 0·8 % (P < 0.01), with 82·9 % achieving < 7.0 %. Time in range 3·9-10·0 mmol/L (TIR) improved to 78·8 ± 12·9 %, with 80·5 % achieving > 70 %, followed by time below 3·9 mmol/L of 3·9 (2·1, 6·1) %. After 12 months, HbA1c and TIR remained similar at 6·4 ± 1·0 % and 77·9 ± 12·2 %. No DKA and severe hypoglycemia was observed.

Interpretation: Real-world data from mainland China highlights current uptake of open-source AAPS with potential glycemic benefits. No safety signals are seen. More support to enhance access and utilization of all AID systems in this region is warranted.

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1 型糖尿病患者使用开源自动胰岛素给药的实际效果和安全性：中国大陆的经验。

背景：开放源码的胰岛素自动给药系统正被越来越多地采用，但在亚洲以外的地区讨论较少。本研究旨在描述安卓人工胰岛（AAPS）在中国大陆 1 型糖尿病（T1DM）患者中的有效性和安全性：这项真实世界研究招募了在2019年至2024年期间开始使用人工胰岛素≥3个月的患者。主要结果包括糖化血红蛋白A1c（HbA1c）和连续血糖监测指标、糖尿病酮症酸中毒（DKA）和严重低血糖的发生率。研究结果：共纳入292名（男性，46-9%）参与者，年龄为25-7（14-7，35-0）岁，其中183人（62-7%）和68人（23-3%）使用AAPS 6个月和12个月。使用 AAPS 之前的 HbA1c 为 7-6 ± 1-7 %，其中 44-5 % 达到 70%，其次是低于 3-9 mmol/L 的时间为 3-9 (2-1, 6-1)%。12 个月后，HbA1c 和 TIR 保持相似，分别为 6-4 ± 1-0 % 和 77-9 ± 12-2%。未观察到 DKA 和严重低血糖：来自中国大陆的真实世界数据突显了目前对开源 AAPS 的接受程度以及潜在的血糖效益。未发现安全信号。有必要提供更多支持，以提高该地区所有 AID 系统的接入和利用率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes research and clinical practice 医学-内分泌学与代谢

CiteScore

10.30

自引率

3.90%

发文量

862

审稿时长

32 days

期刊介绍： Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.