闭环自动胰岛素输送系统对1型糖尿病患者低血糖意识的影响：一项系统评价和荟萃分析。
The impact of closed-loop automated insulin delivery systems on hypoglycaemia awareness in people living with type 1 diabetes: A systematic review and meta-analysis.
作者信息
Efthymiadis Agathoklis, Bastounis Anastasios, Liu Linda, Bourlaki Marianthi, Spinos Dimitrios, Tsikopoulos Konstantinos
机构信息
Department of Diabetes & Endocrinology, Northwick Park Hospital, London North West University Healthcare NHS Trust, Watford Road, London, Harrow HA1 3UJ UK.
Sheffield Centre for Health and Related Research (SCHARR), Division of Population Health, School of Medicine and Population Health, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
出版信息
J Diabetes Metab Disord. 2024 Sep 5;23(2):2251-2261. doi: 10.1007/s40200-024-01492-6. eCollection 2024 Dec.
OBJECTIVES
Impaired awareness of hyperglycaemia (IAH) affects approximately 20-40% of people living with type 1 diabetes (T1D), predisposing them to severe hypoglycaemia. This systematic review evaluated the efficacy of closed-loop automated insulin delivery systems (CL-AID) in restoring IAH compared with standard diabetes care, including other diabetes technologies.
METHODS
Six electronic databases were searched for published and unpublished observational and randomised-control studies (RCTs) from inception to 29th of May 2024. The results of observational studies and RCTs were meta-analysed separately to calculate the effect of CL-AID on IAH in people living with T1D. Quality assessment of studies was performed using the Joanna-Briggs appraisal tool for cohort studies and the Risk of Bias (Rob-2) tool for RCTs.
RESULTS
Meta-analysis of four prospective observations studies (n = 583) demonstrated a statistically significant improvement in hypoglycaemia awareness upon transition to a hybrid closed-loop (HCL) system compared with standard diabetes care in people with T1D, Clarke score mean difference (MD) of -0.45 (-0.69 to -0.22, p = 0.0001). However, this was less than 1 point, which is the minimum clinically important difference (MCID) of Clarke score. Meta-analysis of three RCTs (n = 55) comparing standard diabetes care did not demonstrate any statistically significant effect on hypoglycaemia awareness, Clarke score MD of -0.69 (-1.89 to 0.50, p = 0.26).
CONCLUSIONS
This systematic review demonstrated that transition from standard diabetes care to HCL has the potential to improve hypoglycaemia awareness in people with T1D and IAH, but this might not be of major clinical significance. Hence, psychoeducational interventions continue to be the cornerstone of IAH management. Novel therapeutic modalities, such as bi-hormonal automated delivery systems, need to be further explored to help restore hypoglycaemia awareness.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s40200-024-01492-6.
目的
高血糖意识受损（IAH）影响约20%-40%的1型糖尿病（T1D）患者，使他们易发生严重低血糖。本系统评价评估了闭环自动胰岛素给药系统（CL-AID）与标准糖尿病护理（包括其他糖尿病技术）相比，在恢复IAH方面的疗效。
方法
检索了六个电子数据库，以查找从数据库建立至2024年5月29日发表和未发表的观察性研究和随机对照试验（RCT）。分别对观察性研究和RCT的结果进行荟萃分析，以计算CL-AID对T1D患者IAH的影响。使用乔安娜-布里格斯队列研究评估工具和RCT的偏倚风险（Rob-2）工具对研究进行质量评估。
结果
对四项前瞻性观察性研究（n = 583）的荟萃分析表明，与T1D患者的标准糖尿病护理相比，过渡到混合闭环（HCL）系统后低血糖意识有统计学意义的改善，克拉克评分平均差（MD）为-0.45（-0.69至-0.22，p = 0.0001）。然而，这不到1分，这是克拉克评分的最小临床重要差异（MCID）。对三项比较标准糖尿病护理的RCT（n = 55）的荟萃分析未显示对低血糖意识有任何统计学意义的影响，克拉克评分MD为-0.69（-1.89至0.50，p = 0.26）。
结论
本系统评价表明，从标准糖尿病护理过渡到HCL有可能改善T1D和IAH患者的低血糖意识，但这可能没有重大临床意义。因此，心理教育干预仍然是IAH管理的基石。需要进一步探索新型治疗模式，如双激素自动给药系统，以帮助恢复低血糖意识。
补充信息
在线版本包含可在10.1007/s40200-024-01492-6获取的补充材料。
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