2 results
Not approvedWill not start
Primary Objective:To verify the accuracy and performance of the GlycostatTM System including its ability to secure good glycemic control by means of its algorithm. The accuracy of Glycostat, expressed by MARD (Mean Absolute Relative Difference), the…
Approved WMOCompleted
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…