Stahl-Pehe Anna, Shokri-Mashhadi Nafiseh, Wirth Marielle, Schlesinger Sabrina, Kuss Oliver, Holl Reinhard W, Bächle Christina, Warz Klaus-D, Bürger-Büsing Jutta, Spörkel Olaf, Rosenbauer Joachim
Institute for Biometrics and Epidemiology, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
German Center for Diabetes Research (DZD), Partner Düsseldorf, Munich-Neuherberg, Germany.
EClinicalMedicine. 2025 Apr 11;82:103190. doi: 10.1016/j.eclinm.2025.103190. eCollection 2025 Apr.
The comparative efficacy of automated insulin delivery (AID) systems and other treatment options for type 1 diabetes, accounting for the certainty of evidence (CoE), is unknown.
We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov and included outpatient randomised controlled trials (RCTs) published until January 8, 2025, in people with type 1 diabetes with a three-week or longer intervention of AID systems (PROSPERO registration number: CRD42023395492). We performed pairwise and network meta-analyses and used the Risk of Bias tool 2 and the Grading of Recommendations Assessment, Development and Evaluation methods to determine the CoE for each outcome.
A total of 46 studies involving seven insulin treatment options and 4113 participants were included, of which 29 and 17 had low and moderate risks of bias, respectively. The intervention AID systems, including the hybrid closed-loop (HCL), advanced HCL (AHCL) and full closed-loop (FCL) systems, were evaluated in 20, 25 and 1 studies, respectively. The network meta-analysis did not indicate global inconsistencies but did indicate global publication bias for all glycaemic outcomes. The CoE varied between very low and high, depending on the treatment and outcome under consideration. Compared with pump therapy, the percentage of time in the range 70-180 mg/dl was greater with AID use (HCL: 19.7% [95% confidence interval 13.2%; 26.1%], moderate CoE; AHCL: 24.1% [18.2%; 29.9%], moderate CoE; FCL: 25.5% [11.1%; 39.9%], high CoE). Compared with pump therapy, the percentage of time above 180 mg/dl and 250 mg/dl was lower with AHCL, on average, by 19.6% (14.0%; 25.1%), moderate CoE, and 14.8% (8.8%; 20.8%), moderate CoE, respectively. The CoE was very uncertain regarding the overall effect of AID systems on the percentage of time below 70 mg/dl and 54 mg/dl and the HbA1c.
AID systems improve glycaemic outcomes to varying degrees and with varying CoE.
German Federal Ministry of Education and Research (BMBF; grant 01KG2203).
考虑到证据确定性（CoE），自动胰岛素给药（AID）系统与1型糖尿病其他治疗方案的疗效对比尚不清楚。
我们检索了PubMed、EMBASE、Cochrane对照试验中央注册库和ClinicalTrials.gov，并纳入截至2025年1月8日发表的门诊随机对照试验（RCT），这些试验针对1型糖尿病患者，采用AID系统进行为期三周或更长时间的干预（PROSPERO注册号：CRD42023395492）。我们进行了成对和网状荟萃分析，并使用偏倚风险工具2以及推荐分级评估、制定和评价方法来确定每个结局的CoE。
共纳入46项研究，涉及七种胰岛素治疗方案和4113名参与者，其中29项和17项分别具有低和中度偏倚风险。干预措施AID系统，包括混合闭环（HCL）、先进混合闭环（AHCL）和全闭环（FCL）系统，分别在20项、25项和1项研究中进行了评估。网状荟萃分析未显示总体不一致性，但确实表明所有血糖结局存在总体发表偏倚。CoE因所考虑的治疗和结局而异，范围从极低到高。与胰岛素泵治疗相比，使用AID系统时血糖在70 - 180mg/dl范围内的时间百分比更高（HCL：19.7%[95%置信区间13.2%；26.1%]，中度CoE；AHCL：24.1%[18.2%；29.9%]，中度CoE；FCL：25.5%[11.1%；39.9%]，高度CoE）。与胰岛素泵治疗相比，AHCL使血糖高于180mg/dl和250mg/dl的时间百分比平均分别降低19.6%（14.0%；25.1%），中度CoE，以及14.8%（8.8%；20.8%），中度CoE。关于AID系统对血糖低于70mg/dl和54mg/dl的时间百分比以及糖化血红蛋白（HbA1c）的总体影响，CoE非常不确定。
AID系统在不同程度上并以不同的CoE改善血糖结局。
德国联邦教育与研究部（BMBF；资助编号01KG2203）。
