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本文引用的文献

1
Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range.临床连续血糖监测数据解读目标:时间范围国际共识推荐意见。
Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
2
Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.验证时间在范围内作为糖尿病临床试验的结果测量。
Diabetes Care. 2019 Mar;42(3):400-405. doi: 10.2337/dc18-1444. Epub 2018 Oct 23.
3
Association of Time in Range, as Assessed by Continuous Glucose Monitoring, With Diabetic Retinopathy in Type 2 Diabetes.连续血糖监测评估的时间范围内与 2 型糖尿病患者糖尿病视网膜病变的关系。
Diabetes Care. 2018 Nov;41(11):2370-2376. doi: 10.2337/dc18-1131. Epub 2018 Sep 10.
4
Need for Regulatory Change to Incorporate Beyond A1C Glycemic Metrics.需要进行监管变革以纳入糖化血红蛋白(A1C)以外的血糖指标。
Diabetes Care. 2018 Jun;41(6):e92-e94. doi: 10.2337/dci18-0010.
5
International Consensus on Use of Continuous Glucose Monitoring.连续血糖监测应用的国际共识
Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.
6
Standardizing Clinically Meaningful Outcome Measures Beyond HbA for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.1型糖尿病HbA之外临床有意义结局指标的标准化:美国临床内分泌医师协会、美国糖尿病教育者协会、美国糖尿病协会、内分泌学会、国际青少年糖尿病研究基金会、利昂娜·M.和哈里·B.赫尔姆斯利慈善信托基金、儿科内分泌学会以及T1D交流组织的共识报告
Diabetes Care. 2017 Dec;40(12):1622-1630. doi: 10.2337/dc17-1624.
7
Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes.持续血糖监测:近期研究综述显示血糖结果得到改善
Diabetes Technol Ther. 2017 Jun;19(S3):S25-S37. doi: 10.1089/dia.2017.0035.
8
Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.动态血糖监测在临床试验中的作用:报告建议
Diabetes Technol Ther. 2017 Jul;19(7):391-399. doi: 10.1089/dia.2017.0054. Epub 2017 May 22.
9
Role of continuous glucose monitoring for type 2 in diabetes management and research.持续葡萄糖监测在2型糖尿病管理与研究中的作用。
J Diabetes Complications. 2017 Jan;31(1):280-287. doi: 10.1016/j.jdiacomp.2016.10.007. Epub 2016 Oct 14.
10
Significance and Reliability of MARD for the Accuracy of CGM Systems.平均相对绝对误差(MARD)对连续血糖监测(CGM)系统准确性的意义和可靠性
J Diabetes Sci Technol. 2017 Jan;11(1):59-67. doi: 10.1177/1932296816662047. Epub 2016 Sep 25.

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.

DOI:10.2337/cd20-0049
PMID:33986569
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8061554/
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。