持续葡萄糖监测在上市糖尿病药物临床试验中的应用
Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs.
作者信息
Fox Bradley Q, Benjamin Peninah F, Aqeel Ammara, Fitts Emily, Flynn Spencer, Levine Brian, Maslak Elizaveta, Milner Rebecca L, Ose Benjamin, Poeschla Michael, Ray Meghna, Serino Maeve, Shah Sahaj S, Close Kelly L
机构信息
Close Concerns, San Francisco, CA.
Dartmouth College, Hanover, NH.
出版信息
Clin Diabetes. 2021 Apr;39(2):160-166. doi: 10.2337/cd20-0049.
Abstract
To the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacological agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 antihyperglycemic therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov, 119 (5.9%) of these trials used CGM. CGM usage in clinical trials has increased over time, rising from <5% before 2005 to 12.5% in 2019. However, it is still low given its inclusion in the American Diabetes Association's latest guidelines and known limitations of A1C for assessing ongoing diabetes care.
摘要
据我们所知，目前尚无关于持续葡萄糖监测（CGM）在糖尿病治疗药物临床试验中的历史使用情况和近期使用情况的已发表数据。我们分析了目前市场上40种抗高血糖疗法的2032项临床试验，这些试验的研究开始日期在2000年1月1日至2019年12月31日之间。根据美国国立医学图书馆临床试验数据库（ClinicalTrials.gov），其中119项（5.9%）试验使用了CGM。随着时间的推移，临床试验中CGM的使用有所增加，从2005年之前的<5%上升到2019年的12.5%。然而，鉴于其被纳入美国糖尿病协会的最新指南以及糖化血红蛋白（A1C）在评估糖尿病持续治疗方面已知的局限性，其使用率仍然较低。
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