Saaed Abunada, Sheela Bai, Usha Kumari, F. N. U. Nancy, Areeba Khan, Nikeeta Bai, F. N. U. Shevani, Anusha Bai, Shah Dev, Noshad Zain ul Abiddin, F. N. U. Umer, Abdul Manan, Sadia Habib Bhutto, Salih Abdella Yusuf
{"title":"连续血糖监测和低血糖指标与每周一次的基础胰岛素Fc和胰岛素Degludec:系统回顾和荟萃分析","authors":"Saaed Abunada, Sheela Bai, Usha Kumari, F. N. U. Nancy, Areeba Khan, Nikeeta Bai, F. N. U. Shevani, Anusha Bai, Shah Dev, Noshad Zain ul Abiddin, F. N. U. Umer, Abdul Manan, Sadia Habib Bhutto, Salih Abdella Yusuf","doi":"10.1002/edm2.70067","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Introduction</h3>\n \n <p>Once-weekly basal insulin Fc (BIF) offers a promising alternative to daily basal insulin by reducing injection burden while maintaining glycaemic control. However, comprehensive comparisons with insulin degludec regarding continuous glucose monitoring (CGM) metrics and hypoglycaemia outcomes remain limited. This meta-analysis evaluates these critical parameters.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing once-weekly BIF with once-daily insulin degludec in type 1 and type 2 diabetes. Outcomes included CGM-derived glycaemic variability, time in range, time above/below range and hypoglycaemia event rates. Data were pooled using random-effects models, with heterogeneity assessed via <i>I</i><sup>2</sup> statistics.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Five RCTs (<i>n</i> = 2427) were included. BIF demonstrated comparable glycaemic variability (within-day CV: MD = 0.06, <i>p</i> = 0.90; between-day CV: MD = -0.26, <i>p</i> = 0.30) and Time in range (MD = 0.56, <i>p</i> = 0.27) versus degludec. However, BIF increased time spent in the mild hypoglycaemia range (54–69 mg/dL) (MD = 0.30, <i>p</i> = 0.0004) and clinically significant hypoglycaemia event rates (rate ratio = 1.20, <i>p</i> < 0.00001). Severe hypoglycaemia event rates were higher with BIF (rate ratio = 3.34, <i>p</i> < 0.0001). Nocturnal hypoglycaemia and time above range (> 250 mg/dL) did not differ significantly.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Once-weekly BIF provides similar overall glycaemic control to insulin degludec but with increased time in mild hypoglycaemia and higher event rates of clinically significant and severe hypoglycaemia. These findings highlight the need for individualised dosing and monitoring when transitioning to weekly insulin regimens.</p>\n </section>\n </div>","PeriodicalId":36522,"journal":{"name":"Endocrinology, Diabetes and Metabolism","volume":"8 4","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/edm2.70067","citationCount":"0","resultStr":"{\"title\":\"Continuous Glucose Monitoring and Hypoglycaemia Metrics With Once-Weekly Basal Insulin Fc Versus Insulin Degludec: A Systematic Review and Meta-Analysis\",\"authors\":\"Saaed Abunada, Sheela Bai, Usha Kumari, F. N. U. Nancy, Areeba Khan, Nikeeta Bai, F. N. U. Shevani, Anusha Bai, Shah Dev, Noshad Zain ul Abiddin, F. N. U. Umer, Abdul Manan, Sadia Habib Bhutto, Salih Abdella Yusuf\",\"doi\":\"10.1002/edm2.70067\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Introduction</h3>\\n \\n <p>Once-weekly basal insulin Fc (BIF) offers a promising alternative to daily basal insulin by reducing injection burden while maintaining glycaemic control. However, comprehensive comparisons with insulin degludec regarding continuous glucose monitoring (CGM) metrics and hypoglycaemia outcomes remain limited. This meta-analysis evaluates these critical parameters.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing once-weekly BIF with once-daily insulin degludec in type 1 and type 2 diabetes. Outcomes included CGM-derived glycaemic variability, time in range, time above/below range and hypoglycaemia event rates. Data were pooled using random-effects models, with heterogeneity assessed via <i>I</i><sup>2</sup> statistics.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Five RCTs (<i>n</i> = 2427) were included. BIF demonstrated comparable glycaemic variability (within-day CV: MD = 0.06, <i>p</i> = 0.90; between-day CV: MD = -0.26, <i>p</i> = 0.30) and Time in range (MD = 0.56, <i>p</i> = 0.27) versus degludec. However, BIF increased time spent in the mild hypoglycaemia range (54–69 mg/dL) (MD = 0.30, <i>p</i> = 0.0004) and clinically significant hypoglycaemia event rates (rate ratio = 1.20, <i>p</i> < 0.00001). Severe hypoglycaemia event rates were higher with BIF (rate ratio = 3.34, <i>p</i> < 0.0001). Nocturnal hypoglycaemia and time above range (> 250 mg/dL) did not differ significantly.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Once-weekly BIF provides similar overall glycaemic control to insulin degludec but with increased time in mild hypoglycaemia and higher event rates of clinically significant and severe hypoglycaemia. These findings highlight the need for individualised dosing and monitoring when transitioning to weekly insulin regimens.</p>\\n </section>\\n </div>\",\"PeriodicalId\":36522,\"journal\":{\"name\":\"Endocrinology, Diabetes and Metabolism\",\"volume\":\"8 4\",\"pages\":\"\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-06-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/edm2.70067\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Endocrinology, Diabetes and Metabolism\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/edm2.70067\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Endocrinology, Diabetes and Metabolism","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/edm2.70067","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0
摘要
每周一次的基础胰岛素Fc (BIF)提供了一种有希望的替代每日基础胰岛素的方法,减少了注射负担,同时保持了血糖控制。然而,在持续血糖监测(CGM)指标和低血糖结局方面,与降糖糖胰岛素的综合比较仍然有限。本荟萃分析评估了这些关键参数。方法:我们对1型和2型糖尿病患者的随机对照试验(rct)进行了系统回顾和荟萃分析,比较了每周一次的BIF和每天一次的降糖糖胰岛素。结果包括cgm衍生的血糖变异性、在范围内的时间、高于/低于范围的时间和低血糖事件发生率。采用随机效应模型汇总数据,通过I2统计量评估异质性。结果共纳入5项rct (n = 2427)。BIF表现出相当的血糖变异性(日内CV: MD = 0.06, p = 0.90;日间CV: MD = -0.26, p = 0.30)和范围内时间(MD = 0.56, p = 0.27)。然而,BIF增加了轻度低血糖范围(54-69 mg/dL)的时间(MD = 0.30, p = 0.0004)和临床显著低血糖事件发生率(比率比= 1.20,p < 0.00001)。BIF组严重低血糖事件发生率较高(比率比= 3.34,p < 0.0001)。夜间低血糖和时间高于范围(> 250 mg/dL)无显著差异。结论每周一次BIF与降糖糖胰岛素的总体血糖控制效果相似,但轻度低血糖的时间延长,临床显著性和重度低血糖的发生率更高。这些发现强调了在过渡到每周胰岛素治疗方案时个体化给药和监测的必要性。
Continuous Glucose Monitoring and Hypoglycaemia Metrics With Once-Weekly Basal Insulin Fc Versus Insulin Degludec: A Systematic Review and Meta-Analysis
Introduction
Once-weekly basal insulin Fc (BIF) offers a promising alternative to daily basal insulin by reducing injection burden while maintaining glycaemic control. However, comprehensive comparisons with insulin degludec regarding continuous glucose monitoring (CGM) metrics and hypoglycaemia outcomes remain limited. This meta-analysis evaluates these critical parameters.
Methods
We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing once-weekly BIF with once-daily insulin degludec in type 1 and type 2 diabetes. Outcomes included CGM-derived glycaemic variability, time in range, time above/below range and hypoglycaemia event rates. Data were pooled using random-effects models, with heterogeneity assessed via I2 statistics.
Results
Five RCTs (n = 2427) were included. BIF demonstrated comparable glycaemic variability (within-day CV: MD = 0.06, p = 0.90; between-day CV: MD = -0.26, p = 0.30) and Time in range (MD = 0.56, p = 0.27) versus degludec. However, BIF increased time spent in the mild hypoglycaemia range (54–69 mg/dL) (MD = 0.30, p = 0.0004) and clinically significant hypoglycaemia event rates (rate ratio = 1.20, p < 0.00001). Severe hypoglycaemia event rates were higher with BIF (rate ratio = 3.34, p < 0.0001). Nocturnal hypoglycaemia and time above range (> 250 mg/dL) did not differ significantly.
Conclusion
Once-weekly BIF provides similar overall glycaemic control to insulin degludec but with increased time in mild hypoglycaemia and higher event rates of clinically significant and severe hypoglycaemia. These findings highlight the need for individualised dosing and monitoring when transitioning to weekly insulin regimens.