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 patients.There were 15 class III medical devices that were appr...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 patients.There 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 treatment.In 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 devices.Two exemplars of clinical trials for"Eversense continuous glucose monitoring system"and"t:slim X2 Insulin Pump with Basal-IQ Technology"are discussed in details.展开更多
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.
文摘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 patients.There 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 treatment.In 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 devices.Two exemplars of clinical trials for"Eversense continuous glucose monitoring system"and"t:slim X2 Insulin Pump with Basal-IQ Technology"are discussed in details.
