The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.
Study Type
OBSERVATIONAL
Enrollment
75
AMCR Institute
Escondido, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Clinical point accuracy as assessed by the Consensus Error Grid
Time frame: 14 days
Safety endpoints that include signs and symptoms related to sensor application site
Time frame: 14 days
Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)
Time frame: 14 days
Composite measure: Clinical point accuracy (Clarke Error Grid), trend accuracy (R-deviation, Rate Error Grid and Continuous Glucose Error Grid) and lag time, performance of notifications (sensitivity and false notifications) and questionnaire responses.
Time frame: 14 days
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