Design and analysis of high-risk medical device clinical trials for diabetes monitoring and treatment: a review

作     者：Zhang Bo Shankara Sravya B. Ye Shangyuan Zhang Hui Zhang Bo;Shankara Sravya B.;Ye Shangyuan;Zhang Hui

作者机构：Department of Neurology and ICCTR Biostatistics and Research Design CenterBoston Children’s HospitalHarvard Medical SchoolBoston Program in Health:ScienceSocietyand PolicyBrandeis UniversityWaltham Department of Population MedicineHarvard Pilgrim Health Care and Harvard Medical SchoolBostonMA Division of BiostatisticsDepartment of Preventive MedicineFeinberg School of MedicineNorthwestern UniversityChicagoILUSA 

出 版 物：《Journal of Pancreatology》 (胰腺病学杂志（英文）)

年 卷 期：2019年第2卷第4期

页      面：123-130页

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：HZ would thank the Robert H.Lurie Comprehensive Cancer Center of Northwestern University in Chicago IL for the use of the Quantitative Data Sciences Core.The Lurie Cancer Center is supported in part by an NCI Cancer Center Support Grant#P30CA060553 

主　　题：Analysis Clinical trials Diabetes treatment Glucose monitoring Medical device Study design 

摘      要：Class III medical devices are those devices that support or sustain human life or prevent impairment of human health but,when used,pose high risks to the *** were 15 class III medical devices that were approved by the US Food and Drug Administration from September 1,2005 to December 31,2018 for glucose monitoring and diabetes *** this article,we reviewed the study design and statistical analysis in clinical trials that were conducted to provide evidences for safety and effectiveness of these medical *** exemplars of clinical trials forEversense continuous glucose monitoring systemandt:slim X2 Insulin Pump with Basal-IQ Technologyare discussed in details.