Effect of automated insulin delivery systems on person-reported outcomes in people with diabetes: a systematic review and meta-analysis.

IF 9.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-09-21 eCollection Date: 2024-10-01 DOI:10.1016/j.eclinm.2024.102852

Timm Roos, Norbert Hermanns, Christopher Groß, Bernhard Kulzer, Thomas Haak, Dominic Ehrmann

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Abstract

Background: Conclusive evidence on the benefits of automated insulin delivery (AID) systems on person-reported outcomes (PROs) is missing.

Methods: In this systematic review and meta-analysis, four databases (PubMed, PsycINFO, Cochrane, and GoogleScholar) were searched from inception up to August 7th, 2024. All types of studies were included if studies reported on PROs in people with diabetes using an AID system. All types of control groups in randomised controlled trials (RCT) were included. Summary data were extracted by three reviewers. Main outcomes focused on diabetes distress, fear of hypoglycaemia and quality of life. Meta-analyses were conducted for RCTs and observational studies separately. When five or more studies could be pooled, random-effects meta-analysis was used, otherwise common-effects meta-analysis was used. Risk of bias was evaluated with Cochrane tools. This study was registered with PROSPERO, CRD42022352502.

Findings: A total of 62 studies (n = 9253) were included reporting on 45 different questionnaires. Twenty-seven studies were RCTs and 25 were observational studies. RCT meta-analyses showed reduced diabetes distress (standardised mean difference [95% CI]: -0.159 [-0.309, -0.010], I² = 23.0%), reduced fear of hypoglycaemia (-0.339 [-0.566, -0.111], I² = 42.6%), and improved hypoglycaemia unawareness (-0.231 [-0.424, -0.037], I² = 0.0%), quality of life in adults (0.347 [0.134, 0.560], I² = 0.0%) and children/adolescents (0.249 [0.050, 0.448], I² = 0.0%). Observational meta-analyses corroborated improvements in diabetes distress (-0.217 [-0.403, -0.031], I² = 68.5%), fear of hypoglycaemia (-0.445 [-0.540, -0.349], I² = 0.0%), hypoglycaemia unawareness (-0.212 [-0.419, -0.004], I² = 0.0%), and showed improved sleep quality (-0.158 [-0.255, -0.061], I² = 0.0%).

Interpretation: We found low to moderate effect sizes indicating that AID therapy is associated with reduced burden and improved well-being in people with diabetes. Evidence comes from both RCTs and observational studies. However, for some PROs only a limited number of studies could be pooled with a large heterogeneity in questionnaires used. More research is needed with a more uniformed assessment of PROs to demonstrate the added value of AID therapy on psychosocial outcomes.

Funding: None.

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胰岛素自动给药系统对糖尿病患者个人报告结果的影响：系统综述和荟萃分析。

背景：关于胰岛素自动给药系统（AID）对个人报告结果（PROs）的益处，目前尚无确凿证据：关于胰岛素自动给药系统（AID）对个人报告结果（PROs）的益处尚缺乏确凿证据：在本系统综述和荟萃分析中，检索了从开始到 2024 年 8 月 7 日的四个数据库（PubMed、PsycINFO、Cochrane 和 GoogleScholar）。如果研究报告涉及使用 AID 系统的糖尿病患者的 PROs，则纳入所有类型的研究。随机对照试验（RCT）中所有类型的对照组均包括在内。由三位评审员提取摘要数据。主要结果集中在糖尿病困扰、低血糖恐惧和生活质量方面。对随机对照试验和观察性研究分别进行了荟萃分析。如果有五项或五项以上的研究可以汇总，则采用随机效应荟萃分析，否则采用共效荟萃分析。偏倚风险采用 Cochrane 工具进行评估。本研究已在 PROSPERO 注册，注册号为 CRD42022352502：共纳入了 62 项研究（n = 9253），报告了 45 种不同的问卷。其中 27 项为 RCT 研究，25 项为观察性研究。研究性临床试验荟萃分析表明，糖尿病困扰减少（标准化平均差[95% CI]：-0.159 [-0.309, -0.010]，I2 = 23.0%），对低血糖的恐惧减少（-0.339 [-0.566, -0.111]，I2 = 42.6%），改善低血糖意识（-0.231 [-0.424, -0.037]，I2 = 0.0%），提高成人（0.347 [0.134, 0.560]，I2 = 0.0%）和儿童/青少年（0.249 [0.050, 0.448]，I2 = 0.0%）的生活质量。观察性荟萃分析证实，糖尿病困扰（-0.217 [-0.403, -0.031]，I2 = 68.5%）、低血糖恐惧（-0.445 [-0.540, -0.349]，I2 = 0.0%）、低血糖无意识（-0.212 [-0.419, -0.004]，I2 = 0.0%），并显示睡眠质量有所改善（-0.158 [-0.255, -0.061]，I2 = 0.0%）：我们发现，低度至中度的效应大小表明，AID疗法与减轻糖尿病患者的负担和改善其生活质量有关。证据来自研究性临床试验和观察性研究。然而，对于某些PROs，只有有限的几项研究可以汇总，而且所使用的问卷也存在很大的异质性。需要进行更多的研究，对PROs进行更统一的评估，以证明AID疗法对心理社会结果的附加价值：无。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.