Amer Basma Ehab, Yaqout Yasmeen Essam, Abozaid Ahmed Mohamed, Afifi Eslam, Aboelkhier Menna M
Medical Research Group of Egypt, Negida Academy, Arlington, Massachusetts, USA.
Faculty of Medicine, Benha University, Benha, Egypt.
Diabet Med. 2024 Jan;41(1):e15196. doi: 10.1111/dme.15196. Epub 2023 Aug 18.
This meta-analysis investigated the efficacy and safety of fully closed-loop automated insulin delivery (AID) in patients with type 2 diabetes.
We systemically searched PubMed, Scopus, Web of Science, and Cochrane Central from inception until April 26, 2023. We included randomized controlled trials (RCTs) comparing fully closed-loop AID versus conventional insulin therapy. The outcomes were pooled as the mean difference (MD) and risk ratio with 95% confidence interval (CI) in the random effect model. Our primary outcome was the proportion of time in the target glucose range (5.6-10 mmol/L, 3.9-10 mmol/L, or 3.9-8 mmol/L, depending on the study). Key secondary outcomes included the proportion of time spent in hyperglycaemia or hypoglycaemia.
We included seven RCTs (three crossover and four parallel design), compromising 390 patients. Our analysis showed that compared to the control group, fully closed-loop AID increased the proportion of time spent within the target glucose range by additional 337 min per 24 h (MD = 23.39%, 95% CI [16.64%, 30.14%], p < 0.01), additional 108 min overnight (MD = 22.40%, 95% CI [12.88%, 31.91%], p < 0.01), and additional 258 min during the daytime period (MD = 26.85%, 95% CI [21.06%, 32.63%], p < 0.01). Compared to the control group, the overall time in hyperglycaemia was shortened by 326 min per 24 h (MD = -22.67%, 95% CI [-30.87%, -14.46%], p < 0.01). There was no significant difference between the two groups in terms of overall, overnight, and daytime periods spent in hypoglycaemia.
Our meta-analysis suggests that fully closed-loop AID may improve glycaemic control in patients with type 2 diabetes, particularly for those with more challenging diabetes management. Further research is required to establish the feasibility of implementing these systems in clinical practice. [Correction added on 26 August 2023 after first online publication: Under Results, the first sentence "We included seven RCTs (three crossover and one parallel designs)" has been changed to "We included seven RCTs (three crossover and four parallel designs)".].
本荟萃分析探讨了完全闭环自动胰岛素给药（AID）在2型糖尿病患者中的疗效和安全性。
我们系统检索了从数据库建立至2023年4月26日的PubMed、Scopus、Web of Science和Cochrane Central数据库。我们纳入了比较完全闭环AID与传统胰岛素治疗的随机对照试验（RCT）。在随机效应模型中，将结果合并为平均差（MD）和风险比，并给出95%置信区间（CI）。我们的主要结局是血糖处于目标范围内的时间比例（根据研究不同，目标范围为5.6 - 10 mmol/L、3.9 - 10 mmol/L或3.9 - 8 mmol/L）。关键次要结局包括高血糖或低血糖持续时间比例。
我们纳入了七项RCT（三项交叉设计和四项平行设计），共390例患者。我们的分析表明，与对照组相比，完全闭环AID使每24小时血糖处于目标范围内的时间增加了337分钟（MD = 23.39%，95% CI [16.64%，30.14%]，p < 0.01），夜间增加了108分钟（MD = 22.40%，95% CI [12.88%，31.91%]，p < 0.01），白天增加了258分钟（MD = 26.85%，95% CI [21.06%，32.63%]，p < 0.01）。与对照组相比，每24小时高血糖总时长缩短了326分钟（MD = -22.67%，95% CI [-30.87%，-14.46%]，p < 0.01）。两组在低血糖总时长、夜间低血糖时长和白天低血糖时长方面无显著差异。
我们的荟萃分析表明，完全闭环AID可能改善2型糖尿病患者的血糖控制，特别是对于糖尿病管理更具挑战性的患者。需要进一步研究以确定在临床实践中应用这些系统的可行性。[2023年8月26日首次在线发表后添加的更正：在结果部分，第一句“We included seven RCTs (three crossover and one parallel designs)”已改为“We included seven RCTs (three crossover and four parallel designs)”。]
