Ludovico Di Gioia, Sergio Di Molfetta, Irene Caruso, Mariangela Caporusso, Gian Pio Sorice, Angelo Cignarelli, Annalisa Natalicchio, Sebastio Perrini, Luigi Laviola, Francesco Giorgino
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We included randomized controlled trials (RCTs) comparing insulin icodec or efsitora against once-daily basal insulins in people with type 1 diabetes. Three reviewers independently evaluated the retrieved citations. The primary outcome was the change in HbA1c. Meta-analysis was performed using fixed- or random-effects models based on heterogeneity.</p><p><strong>Results: </strong>Five RCTs were included, enrolling 1629 adults living with type 1 diabetes. Once-weekly and once-daily basal insulins had similar effects on HbA1c (high certainty), body weight (moderate certainty), time in range (moderate certainty) and time above range. However, safety concerns emerged due to increased rates of level 3 hypoglycaemia (incidence rate ratio 2.532, 95% confidence interval [CI] 1.758-3.645; moderate certainty). A significantly lower weekly bolus insulin dose was observed with once-weekly basal insulin therapy (estimated treatment ratio 0.837, 95% CI 0.794-0.882, I<sup>2</sup> = 0%; high certainty).</p><p><strong>Conclusions: </strong>This meta-analysis is the first to evaluate the efficacy and safety of once-weekly basal insulin therapy exclusively in adults with type 1 diabetes and including all published RCTs. 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引用次数: 0
摘要
目的:在1型或2型糖尿病患者中,每周一次的基础胰岛素与每天一次的类似药物相比,可能提供相似或更好的HbA1c降低。然而,对于每天多次注射的个体,对低血糖的担忧仍然存在。这项荟萃分析(PROSPERO CRD42024606874)旨在评估每周一次基础胰岛素治疗1型糖尿病的疗效和安全性。材料和方法:系统检索MEDLINE、Web of Science和CENTRAL,检索时间截止到2025年4月1日。我们纳入了比较胰岛素icodec或efsitora与1型糖尿病患者每日一次基础胰岛素的随机对照试验(rct)。三位审稿人独立评估检索到的引文。主要终点是HbA1c的变化。采用基于异质性的固定效应或随机效应模型进行meta分析。结果:纳入了5项随机对照试验,纳入了1629名患有1型糖尿病的成年人。每周一次和每天一次的基础胰岛素对HbA1c(高确定性)、体重(中等确定性)、在范围内的时间(中等确定性)和在范围以上的时间有相似的影响。然而,由于3级低血糖发生率增加(发病率比2.532,95%可信区间[CI] 1.758-3.645;中等确定性),安全性问题出现了。每周一次基础胰岛素治疗显著降低每周胰岛素剂量(估计治疗比0.837,95% CI 0.794-0.882, I2 = 0%;高确定性)。结论:这项荟萃分析首次评估了每周一次的1型糖尿病成人基础胰岛素治疗的有效性和安全性,并纳入了所有已发表的随机对照试验。分析表明,与每日一次基础胰岛素相比,降糖效果相似,但严重低血糖的发生率增加。
Efficacy and safety of once-weekly basal insulin therapy in people with type 1 diabetes: A systematic review and meta-analysis.
Aims: Once-weekly basal insulins may offer similar or superior HbA1c reduction compared to once-daily analogues in people with type 1 or type 2 diabetes. However, concerns about hypoglycaemia persist in individuals on multiple daily injections. This meta-analysis (PROSPERO CRD42024606874) aimed to evaluate the efficacy and safety of once-weekly basal insulin therapy in type 1 diabetes.
Materials and methods: A systematic search was conducted in MEDLINE, Web of Science and CENTRAL up to 1 April 2025. We included randomized controlled trials (RCTs) comparing insulin icodec or efsitora against once-daily basal insulins in people with type 1 diabetes. Three reviewers independently evaluated the retrieved citations. The primary outcome was the change in HbA1c. Meta-analysis was performed using fixed- or random-effects models based on heterogeneity.
Results: Five RCTs were included, enrolling 1629 adults living with type 1 diabetes. Once-weekly and once-daily basal insulins had similar effects on HbA1c (high certainty), body weight (moderate certainty), time in range (moderate certainty) and time above range. However, safety concerns emerged due to increased rates of level 3 hypoglycaemia (incidence rate ratio 2.532, 95% confidence interval [CI] 1.758-3.645; moderate certainty). A significantly lower weekly bolus insulin dose was observed with once-weekly basal insulin therapy (estimated treatment ratio 0.837, 95% CI 0.794-0.882, I2 = 0%; high certainty).
Conclusions: This meta-analysis is the first to evaluate the efficacy and safety of once-weekly basal insulin therapy exclusively in adults with type 1 diabetes and including all published RCTs. The analysis demonstrated a similar glucose-lowering effect compared to once-daily basal insulin but revealed an increased occurrence of severe hypoglycaemia.
期刊介绍:
Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.