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闭环胰岛素输送与传感器增强型泵治疗 1 型糖尿病成人患者的疗效和安全性:系统评价和随机对照试验的荟萃分析。

Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials.

机构信息

Department of Thoracic Surgery, The Second Affiliated Hospital of Nanchang University, 1 Minde Road, Nanchang, 330006, China.

Jiangxi Medical College, Nanchang University, Nanchang, 330006, China.

出版信息

J Endocrinol Invest. 2022 Mar;45(3):471-481. doi: 10.1007/s40618-021-01674-6. Epub 2021 Sep 17.

Abstract

BACKGROUND

Controversy remains regarding whether closed-loop (CL) insulin delivery or insulin sensor-augmented pump (SAP) delivery is more efficient for clinical treatment. Therefore, we aimed to compare the efficacy and safety of CL insulin delivery systems versus insulin SAP delivery for adults with type 1 diabetes (T1D).

METHODS

Embase, Ovid MEDLINE, PubMed, ScienceDirect, Scopus, the Cochrane Library, and other databases were searched for related articles, and we analyzed the average blood glucose (BG), time in range (TIR), and adverse effects (AEs) as primary endpoints to evaluate efficacy and safety.

RESULTS

Of 1616 articles, 12 randomized-controlled trials (RCTs) were included in the final analysis. Regarding BG control efficacy, CL insulin delivery resulted better outcomes than SAP therapy with regard to the average BG value, which was detected and recorded by continuous glucose monitoring (mean difference [MD][mmol/L]:  - 0.25 95% confidence interval [CI]  - 0.42 to - 0.08, p = 0.003); TIR 3.9-10 mmol/L (MD [%]: 7.91 95% CI 4.45-11.37, p < 0.00001). Similar results were observed for the secondary outcomes including low blood glucose index (LBGI) (MD:  - 0.41 95% CI - 0.55 to - 0.26, p < 0.00001), high blood glucose index (HBGI) (MD:  - 2.56 95% CI - 3.38 to - 1.74, p < 0.00001), and standard deviation (SD) of glucose variability (MD [mmol/L]: -0.25 95% CI - 0.44 to - 0.06, p = 0.01). Furthermore, SAP therapy was associated with more adverse effects (risk ratio: 0.20 95% CI 0.07-0.52, p = 0.001) than CL insulin delivery, and one of the most common adverse effects was hypoglycemia.

CONCLUSIONS

CL insulin delivery appears to be a better treatment method than SAP therapy for adults with T1D because of its increased BG control efficacy and decreased number of hypoglycemic events.

摘要

背景

闭环(CL)胰岛素输送或胰岛素传感器增强型泵(SAP)输送在临床治疗方面哪个更有效仍存在争议。因此,我们旨在比较 CL 胰岛素输送系统与成人 1 型糖尿病(T1D)患者的 SAP 胰岛素输送的疗效和安全性。

方法

在 Embase、Ovid MEDLINE、PubMed、ScienceDirect、Scopus、Cochrane 图书馆和其他数据库中搜索相关文章,并将平均血糖(BG)、达标时间(TIR)和不良反应(AE)分析作为主要终点,以评估疗效和安全性。

结果

在 1616 篇文章中,最终有 12 项随机对照试验(RCT)被纳入分析。关于 BG 控制效果,CL 胰岛素输送在通过连续血糖监测检测和记录的平均 BG 值方面优于 SAP 治疗(平均差值 [MD] [mmol/L]:-0.25,95%置信区间 [CI]:-0.42 至-0.08,p=0.003);TIR 3.9-10mmol/L(MD [%]:7.91,95% CI:4.45-11.37,p<0.00001)。对于包括低血糖指数(LBGI)(MD:-0.41,95% CI:-0.55 至-0.26,p<0.00001)、高血糖指数(HBGI)(MD:-2.56,95% CI:-3.38 至-1.74,p<0.00001)和血糖变异性标准差(MD [mmol/L]:-0.25,95% CI:-0.44 至-0.06,p=0.01)在内的次要结局,也观察到了类似的结果。此外,SAP 治疗与更多不良反应相关(风险比:0.20,95% CI 0.07-0.52,p=0.001),而 CL 胰岛素输送则相反,最常见的不良反应之一是低血糖。

结论

CL 胰岛素输送似乎是 T1D 成人的一种更好的治疗方法,因为它能提高 BG 控制效果并减少低血糖事件的发生。

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