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基于开源和商业自动化胰岛素输注系统的 1 型糖尿病患者临床结局的真实世界证据:一项系统评价。

Real-world evidence on clinical outcomes of people with type 1 diabetes using open-source and commercial automated insulin dosing systems: A systematic review.

机构信息

Charité - Universitätsmedizin Berlin, Department of Paediatric Endocrinology and Diabetes, Berlin, Germany.

Berlin Institute of Health (BIH), Berlin, Germany.

出版信息

Diabet Med. 2022 May;39(5):e14741. doi: 10.1111/dme.14741. Epub 2021 Nov 24.

Abstract

AIMS

Several commercial and open-source automated insulin dosing (AID) systems have recently been developed and are now used by an increasing number of people with diabetes (PwD). This systematic review explored the current status of real-world evidence on the latest available AID systems in helping to understand their safety and effectiveness.

METHODS

A systematic review of real-world studies on the effect of commercial and open-source AID system use on clinical outcomes was conducted employing a devised protocol (PROSPERO ID 257354).

RESULTS

Of 441 initially identified studies, 21 published 2018-2021 were included: 12 for Medtronic 670G; one for Tandem Control-IQ; one for Diabeloop DBLG1; two for AndroidAPS; one for OpenAPS; one for Loop; three comparing various types of AID systems. These studies found that several types of AID systems improve Time-in-Range and haemoglobin A (HbA ) with minimal concerns around severe hypoglycaemia. These improvements were observed in open-source and commercially developed AID systems alike.

CONCLUSIONS

Commercially developed and open-source AID systems represent effective and safe treatment options for PwD of several age groups and genders. Alongside evidence from randomized clinical trials, real-world studies on AID systems and their effects on glycaemic outcomes are a helpful method for evaluating their safety and effectiveness.

摘要

目的

最近已经开发出了几种商业和开源的自动胰岛素给药 (AID) 系统,并且现在越来越多的糖尿病患者 (PwD) 使用这些系统。本系统评价探讨了最新可用的 AID 系统在帮助理解其安全性和有效性方面的现有真实世界证据的现状。

方法

采用既定方案 (PROSPERO ID 257354) 对关于商业和开源 AID 系统使用对临床结果影响的真实世界研究进行了系统评价。

结果

最初确定的 441 项研究中,纳入了 21 项 2018-2021 年发表的研究:12 项关于 Medtronic 670G;1 项关于 Tandem Control-IQ;1 项关于 Diabeloop DBLG1;2 项关于 AndroidAPS;1 项关于 OpenAPS;1 项关于 Loop;3 项比较各种类型的 AID 系统。这些研究发现,几种类型的 AID 系统可以改善时间范围内的控制和血红蛋白 A1c (HbA1c),同时低血糖症的严重程度最小。开源和商业开发的 AID 系统都观察到了这些改进。

结论

商业开发和开源的 AID 系统代表了具有不同年龄组和性别的 PwD 的有效和安全的治疗选择。除了随机临床试验的证据外,关于 AID 系统及其对血糖结果影响的真实世界研究也是评估其安全性和有效性的有用方法。

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