Type 2 Diabetes Mellitus Clinical Trial
Official title:
Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional
This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2 diabetes management. This is a non-significant risk study.
Subjects will wear two Sensors, one applied to the back of each upper arm, for a period of
14 days. Subjects will wear the Sensor while going about their normal daily activities
during the home use period. Subjects will not be able to see any glucose data. The devices
will be removed at the completion of the final study visit.
Data obtained from the Reader and reports generated by the system will not be used by the
subject or the research team members to determine treatment. Subjects must adhere to their
diabetes clinical management plan established prior to the study.
No additional medical care will be provided to study subjects following study completion
other than care related to the follow up and treatment of adverse events.
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