Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices

摘要

In this issue of Journal of Diabetes Science and Technology (JDST) Philis-Tsimikas and colleagues report that it was nec- essary to revise the protocol of a multicenter drug study because of a safety concern that the FDA-cleared blood glu- cose monitoring system (BGMS) used in this study was not accurate. In this study, compared to a prior similar clinical trial with a similar study population, mean values of hemo- globin Alc (HbAIc) and fasting plasma glucose concentra- tions were lower, while mean self monitored blood glucose (SMBG) values were higher. Because of safety concerns, the original glycemic data collection system (MyGlucoHealth blood glucose meter + electronic diary) was discontinued and replaced with an alternate BGMS. The actions of the study sponsors were intended to ensure that the scientific integrity of the pharmaceutical trial was not compromised.