NCT02283411

Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems

Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Abbott Sensor Based Glucose Monitoring System	Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-11-05
• Last updated: 2018-02-22
• Results posted: 2018-02-22

Locations

6 sites across 1 country: United States