Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System
Amulti-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.Locations in: California, Michigan, Missouri, North Carolina & Texas
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.
Further study details as provided by Abbott Diabetes Care:
Primary Outcome Measures:
Glucose variability as measured by AGP Interquartile Range, (IQR) obtained via System-Pro Sensor. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Assessment of ambulatory glucose profiles (AGPs) generated by the Software [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 132
Source and Details: https://clinicaltrials.gov/ct2/show/NCT02336945