A systematic literature review and meta-analysis of real-world evidence on commercially available automated insulin delivery systems in people with type 1 diabetes.

IF 5.7 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Johannes Pöhlmann, Jayne Smith-Palmer, Erik H Serné, Anna-Kaisa Tuomaala, Johan Jendle, Pratik Choudhary, Emanuele Bosi, Viswanathan Mohan, Tim van den Heuvel, Ohad Cohen, Richard F Pollock
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Abstract

Aims: Automated insulin delivery (AID) is part of the standard of care for type 1 diabetes (T1D), but real-world evidence (RWE) comparing AID systems remains limited. A systematic review and meta-analysis was conducted for outcomes across commercially available AID systems in real-world settings.

Materials and methods: PubMed and Embase were searched to March 2025 for RWE studies of commercial AID systems in ambulatory people with T1D. Eligible studies had n ≥ 250 with ≥10 days of continuous glucose monitoring data. Main outcomes were time in range (TIR) and glycated haemoglobin (HbA1c). Random-effects meta-analyses with AID system as moderator were performed, including scenario analyses by age and optimal device settings.

Results: Thirty-six records covering 34 studies with 635 463 users were included. Studies evaluated MiniMed™ 780G (n = 16), Control-IQ™ (n = 9), MiniMed™ 670G (n = 6), and other systems (≤3 studies each). Meta-analysis demonstrated frequently statistically significant between-system differences in TIR, ranging from 60.1% (95% confidence interval [CI] 54.0 to 65.9) for Omnipod® 5 to 73.9% (95% CI 72.3 to 75.5) for MiniMed 780G. For HbA1c, estimates ranged from 6.5% (95% CI 5.4 to 7.7) for Loop to 7.0% (95% CI 6.7 to 7.4) for MiniMed 780G, although differences were not significant. Significant residual heterogeneity was observed. Age was an important effect modifier, with younger users experiencing less favourable outcomes. Optimal device settings improved glycaemic outcomes.

Conclusions: RWE demonstrated differences in glycaemic outcomes, including TIR, between commercially available AID systems. User age influenced outcomes for all systems. Results must be interpreted cautiously given challenges and potential biases with RWE.

对1型糖尿病患者市售自动胰岛素输送系统的实际证据进行系统的文献综述和荟萃分析。
目的:自动胰岛素输送(AID)是1型糖尿病(T1D)护理标准的一部分,但比较AID系统的真实证据(RWE)仍然有限。对实际环境中市售AID系统的结果进行了系统回顾和荟萃分析。材料和方法:检索PubMed和Embase至2025年3月的商业辅助系统在流动T1D患者中的RWE研究。符合条件的研究有n≥250项,连续血糖监测数据≥10天。主要结局是生存时间(TIR)和糖化血红蛋白(HbA1c)。以AID系统为调节因子进行随机效应荟萃分析,包括年龄和最佳设备设置的情景分析。结果:纳入了34项研究的36条记录,涉及635 463名用户。研究评估了MiniMed™780G (n = 16)、Control-IQ™(n = 9)、MiniMed™670G (n = 6)和其他系统(每个≤3个研究)。荟萃分析显示,系统间TIR差异通常具有统计学意义,从Omnipod®5的60.1%(95%可信区间[CI] 54.0至65.9)到MiniMed 780G的73.9%(95%可信区间[CI] 72.3至75.5)。对于HbA1c, Loop组的估计范围为6.5% (95% CI 5.4 - 7.7), MiniMed 780G组的估计范围为7.0% (95% CI 6.7 - 7.4),尽管差异不显著。观察到显著的剩余异质性。年龄是一个重要的影响因素,年轻的用户经历的结果不太好。优化设备设置可改善血糖结局。结论:RWE证明了商用AID系统在血糖结局(包括TIR)方面的差异。用户年龄影响所有系统的结果。考虑到RWE的挑战和潜在的偏差,必须谨慎地解释结果。
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, Obesity & Metabolism
Diabetes, Obesity & Metabolism 医学-内分泌学与代谢
CiteScore
10.90
自引率
6.90%
发文量
319
审稿时长
3-8 weeks
期刊介绍: Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.
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