In this example study, "blinded" CGM devices were provided by the sponsor to monitor subjects' glucose levels independently of their usual insulin management regime. Each CGM device was attached to a subject and collected glucose levels over time. The device did not provide any information to the subject: The device did not notify the subject of high/low glucose levels and the subject did not have access to the collected information, which was downloaded periodically by the investigator. As these devices were provided by the sponsor, the sponsor collected information about the individual devices. The sponsor needed to record the blinding status of the output from these devices (the notifications and results) as well as the software version of the devices and, as neither the blinding status of the device output nor the software version changed over the course of the study, the DO domain was used to do this. The table below shows 3 of the CGM devices used in the study, all of which were blinded and used the same software version. Certain Expected variables may have been omitted in consideration of space and clarity.
|2||T001||DO||CGM-1||2||DVOPBLST||Device Output Blinding Status||SUBJECT-BLINDED|
|4||T001||DO||CGM-2||2||DVOPBLST||Device Output Blinding Status||SUBJECT-BLINDED|
|6||T001||DO||CGM-3||2||DVOPBLST||Device Output Blinding Status||SUBJECT-BLINDED|