Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark
Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark.
BMJ Open. 2020 Nov 14;10(11):e038970. doi: 10.1136/bmjopen-2020-038970.
Obesity increases the risk of comorbidities and diabetes-related complications and, consequently, efforts to prevent and reduce excess weight in people with type 1 diabetes are essential. The aim of this systematic review and network meta-analysis is to assess the effect of adjunctive glucose-lowering drugs on body weight and other important health outcomes in people with type 1 diabetes.
This systematic review and network meta-analysis will include randomised controlled trials (RCTs) evaluating the use of adjunctive glucose-lowering drugs for treatment of people with type 1 diabetes. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched from inception to present. Key eligibility criteria include: RCT study design; adult participants with type 1 diabetes; treatment with a glucose-lowering drug for ≥24 weeks; and comparison of the intervention to placebo, usual care or another glucose-lowering drug. The primary outcome is change in body weight. Other major outcomes include change in HbA1c and total daily insulin dose and risk of hypoglycaemia and other adverse events. Dual study selection, data extraction and risk of bias assessment will be performed. Results from the meta-analysis will be presented as weighted mean differences for continuous outcomes and risk ratios for dichotomous outcomes. Sources of heterogeneity will be explored by subgroup and sensitivity analysis. A network meta-analysis for the primary outcome will be performed using an arm-based random-effects model based on the Bayesian framework while assessing for transitivity across studies and consistency between direct and indirect estimates. The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach for each outcome.
No ethical assessment is required. The results of this review will be disseminated through peer-reviewed publication and conference presentation.
CRD42020158676.
肥胖会增加合并症和糖尿病相关并发症的风险，因此，努力预防和减少 1 型糖尿病患者的体重超标至关重要。本系统评价和网络荟萃分析的目的是评估辅助降糖药物对 1 型糖尿病患者体重和其他重要健康结局的影响。
本系统评价和网络荟萃分析将包括评估辅助降糖药物治疗 1 型糖尿病患者的随机对照试验（RCT）。将从建库开始检索 MEDLINE、EMBASE、Cochrane 对照试验中心注册库、Cochrane 系统评价数据库、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台。主要纳入标准包括：RCT 研究设计；成人 1 型糖尿病患者；治疗 24 周以上的降糖药物；干预措施与安慰剂、常规护理或其他降糖药物的比较。主要结局是体重变化。其他主要结局包括 HbA1c 和总每日胰岛素剂量变化以及低血糖和其他不良事件风险。将进行双重研究选择、数据提取和偏倚风险评估。荟萃分析的结果将以连续结局的加权均数差和二分类结局的风险比呈现。通过亚组分析和敏感性分析探索异质性来源。将使用基于贝叶斯框架的基于臂的随机效应模型对主要结局进行网络荟萃分析，同时评估研究间的可传递性和直接与间接估计之间的一致性。将使用推荐、评估、开发和评估方法对每个结局进行整体证据质量评估。
不需要伦理评估。本综述的结果将通过同行评审出版物和会议报告进行传播。
PROSPERO 注册号：CRD42020158676。
