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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
156
Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
William Sansum Diabetes Center
Santa Barbara, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI).
Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL.
Time frame: 14 days
Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.
Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study.
Time frame: Safety was evaluated throughout the subject's study participation.
The Trend Accuracy of the System P Device Performance Was Evaluated.
Trend accuracy of the device performance was assessed by comparing of the glucose rate of change results between the sensor glucose readings and YSI reference results for System P only.
Time frame: 14 days
The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated.
The Continuous Glucose Error Grid Analysis (CG-EGA) in the Hypoglycemic range (YSI ≤ 70 mg/dL), in the Euglycemic range (70 \< YSI ≤ 180 mg/dL) and in the Hyperglycemic range (YSI \> 180 mg/dL) were evaluated.
Time frame: 14 days
The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG).
Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the capillary blood glucose (BG) value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for capillary blood glucose (BG) levels \<80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had approximately112 capillary blood glucose (BG) samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the BG value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG levels \<80 mg/dL.
Time frame: 14 days
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