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

Abstract

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.