Efficacy, safety, and patient-centered outcomes of needle-free injectors versus insulin pens in diabetes management: a comprehensive meta-analysis

To evaluate the comparative effectiveness, safety, and patient acceptance of needle-free injectors and insulin pens through a meta-analysis. A thorough literature search was performed across multiple databases, including CNKI, the Weipu Database, the Wanfang Database, PubMed, Embase, and The Cochrane Library for randomized controlled trials (RCTs) on the use of needle-free injectors and insulin pens in diabetes treatment, with a time frame from database inception until June 2024. Five researchers carefully screened the literature in accordance with the inclusion and exclusion criteria, assessed study quality with validated tools and conducted the meta-analysis using RevMan 5.4. This study included 22 publications encompassing 22 studies, involving a total of 2,580 patients, with 1,290 in the needle-free group and 1,290 in the insulin pen group. The findings suggest that needle-free injectors were superior to insulin pens in improving treatment efficacy, local adverse reactions, and increasing patient acceptability, with statistically significant differences. However, no significant variations were observed in continuous glucose monitoring. Needle-free injectors can improve certain aspects of glycemic control, such as reducing HbA1c, FPG, and 2hPPG; improve local adverse reactions and increase patient acceptability. However, improvements in glycemic variability metrics were not statistically significant, indicating that further research is needed to fully assess their long-term safety and therapeutic effectiveness. In terms of systemic safety, the risk of hypoglycemia in the needle-free group was not significantly different from that in the needle group (<i>P</i> = 0.14). Additionally, our publication bias analysis revealed potential biases in the outcomes related to hypoglycemia and insulin dosage.

本研究通过荟萃分析（meta-analysis）评估无针注射器与胰岛素笔的临床疗效、安全性及患者接受度差异。我们对多个数据库开展全面文献检索，涵盖中国知网（CNKI）、维普数据库、万方数据库、PubMed、Embase及科克伦图书馆（The Cochrane Library），检索时限为各数据库建库至2024年6月，检索主题为糖尿病治疗中使用无针注射器与胰岛素笔的随机对照试验（randomized controlled trials, RCTs）。由5名研究人员严格按照纳入排除标准进行文献筛选，采用经过验证的工具评估研究质量，并使用RevMan 5.4软件完成荟萃分析。本研究最终纳入22篇文献，共22项研究，涉及总样本量2580例患者，其中无针注射组与胰岛素笔组各1290例。研究结果显示，无针注射器在提升治疗疗效、改善局部不良反应及提高患者接受度方面均优于胰岛素笔，差异具有统计学意义；但在持续葡萄糖监测（continuous glucose monitoring, CGM）相关指标上未观察到显著差异。无针注射器可改善血糖控制的部分指标，如降低糖化血红蛋白（HbA1c）、空腹血糖（FPG）及餐后2小时血糖（2hPPG）水平，同时改善局部不良反应并提升患者接受度；但血糖变异性相关指标的改善未达到统计学显著性，提示仍需开展进一步研究以全面评估其长期安全性与治疗疗效。在全身安全性方面，无针注射组的低血糖发生风险与胰岛素笔组相比无显著差异（P=0.14）。此外，发表偏倚分析结果显示，低血糖与胰岛素剂量相关的结局指标存在潜在发表偏倚。