At a glance
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Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional
In Brief
A clinical study evaluating Abbott Sensor Based Glucose Monitoring System for Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2. Completed, enrolled 156 participants across 6 sites.
Detailed Summary
The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional Sensors will be worn by adult subjects over a 14-day wear period. The primary objective is to characterize the Systems performance with respect to Yellow Spring Instrument (YSI) reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in reference to YSI. Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants. 240 subjects will be enrolled and additional healthy subjects may also be enrolled in the study as training subjects.
Study Details
Timeline
Interventions
Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.