Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional
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.
Sensors are inserted into the back of the subject's upper arm for up to fourteen (14) days. The subjects are expected to perform capillary BG tests during the 14-day sensor wear. Three in clinic visits are scheduled during the 14-day sensor wear period. During each in-clinic visit, study staff performed IV blood draws to obtain venous blood for YSI reference glucose measurements. ;
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