Clinical Research and Evidence Based Medicine Unit, Aristotle University of Thessaloniki, 54642 Thessaloniki, Greece.
Diabetes Centre, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
BMJ. 2018 Apr 18;361:k1310. doi: 10.1136/bmj.k1310.
To evaluate the efficacy and safety of artificial pancreas treatment in non-pregnant outpatients with type 1 diabetes.
Systematic review and meta-analysis of randomised controlled trials.
Medline, Embase, Cochrane Library, and grey literature up to 2 February 2018.
Randomised controlled trials in non-pregnant outpatients with type 1 diabetes that compared the use of any artificial pancreas system with any type of insulin based treatment. Primary outcome was proportion (%) of time that sensor glucose level was within the near normoglycaemic range (3.9-10 mmol/L). Secondary outcomes included proportion (%) of time that sensor glucose level was above 10 mmol/L or below 3.9 mmol/L, low blood glucose index overnight, mean sensor glucose level, total daily insulin needs, and glycated haemoglobin. The Cochrane Collaboration risk of bias tool was used to assess study quality.
40 studies (1027 participants with data for 44 comparisons) were included in the meta-analysis. 35 comparisons assessed a single hormone artificial pancreas system, whereas nine comparisons assessed a dual hormone system. Only nine studies were at low risk of bias. Proportion of time in the near normoglycaemic range (3.9-10.0 mmol/L) was significantly higher with artificial pancreas use, both overnight (weighted mean difference 15.15%, 95% confidence interval 12.21% to 18.09%) and over a 24 hour period (9.62%, 7.54% to 11.7%). Artificial pancreas systems had a favourable effect on the proportion of time with sensor glucose level above 10 mmol/L (-8.52%, -11.14% to -5.9%) or below 3.9 mmol/L (-1.49%, -1.86% to -1.11%) over 24 hours, compared with control treatment. Robustness of findings for the primary outcome was verified in sensitivity analyses, by including only trials at low risk of bias (11.64%, 9.1% to 14.18%) or trials under unsupervised, normal living conditions (10.42%, 8.63% to 12.2%). Results were consistent in a subgroup analysis both for single hormone and dual hormone artificial pancreas systems.
Artificial pancreas systems are an efficacious and safe approach for treating outpatients with type 1 diabetes. The main limitations of current research evidence on artificial pancreas systems are related to inconsistency in outcome reporting, small sample size, and short follow-up duration of individual trials.
评估人工胰腺治疗 1 型糖尿病非妊娠门诊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。
截至 2018 年 2 月 2 日，检索了 Medline、Embase、Cochrane 图书馆和灰色文献。
比较任何人工胰腺系统与任何类型的基于胰岛素治疗的 1 型糖尿病非妊娠门诊患者的随机对照试验。主要结局是传感器血糖水平处于接近正常血糖范围（3.9-10mmol/L）的时间比例（%）。次要结局包括传感器血糖水平高于 10mmol/L 或低于 3.9mmol/L 的时间比例、夜间低血糖指数、平均传感器血糖水平、总日胰岛素需求和糖化血红蛋白。使用 Cochrane 协作风险偏倚工具评估研究质量。
荟萃分析纳入了 40 项研究（1027 名参与者，44 项比较）。35 项比较评估了单一激素人工胰腺系统，9 项比较评估了双激素系统。只有 9 项研究的偏倚风险较低。使用人工胰腺时，无论是夜间（加权平均差异 15.15%，95%置信区间 12.21%-18.09%）还是 24 小时期间（9.62%，7.54%-11.7%），接近正常血糖范围（3.9-10.0mmol/L）的时间比例均显著升高。与对照组相比，人工胰腺系统在 24 小时内传感器血糖水平高于 10mmol/L（-8.52%，-11.14%至-5.9%）或低于 3.9mmol/L（-1.49%，-1.86%至-1.11%）的时间比例具有有利影响。在敏感性分析中，通过纳入仅低偏倚风险（11.64%，9.1%-14.18%）或在未监督、正常生活条件下进行的试验（10.42%，8.63%-12.2%），对主要结局的发现进行了稳健性验证。亚组分析结果在单激素和双激素人工胰腺系统中均一致。
人工胰腺系统是治疗 1 型糖尿病门诊患者的一种有效且安全的方法。目前关于人工胰腺系统的研究证据的主要局限性与结果报告的不一致、样本量小以及个别试验的随访时间短有关。
