The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus.
This is a prospective, open-label, randomized, multicenter, single-arm pivotal study without control groups in up to 150 adult subjects with type 1 or type 2 diabetes mellitus who will be enrolled at 12 investigational sites in the United States. All subjects are required to wear 1 Sensor on the back of each upper arm for up to 15 days (up to 360 hours) and participate in 4 in-clinic visits. All subjects will have frequent venous blood draws to evaluate the blood glucose reference measurements in each in-clinic visit and collect accurate information against a laboratory reference method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
RIGHTEST Continuous Glucose Monitoring System
Lakeview Clinical Research
Guntersville, Alabama, United States
Novak Clinical Research
Tucson, Arizona, United States
Hope Clinical Research LLC
Canoga Park, California, United States
RIGHTEST Continuous Glucose Monitoring System Performance
The CGM System performance will be primarily evaluated in terms of point and trend accuracy of RIGHTEST™ CGM System continuous interstitial glucose measurements compared to the reference method.
Time frame: 15 days
To investigate the RIGHTEST Glucose Monitoring System other system performance and safety
The secondary objective is to investigate other system performance by comparing the CGM System readings to the reference method. System performance includes the point and the trend accuracy, the precision of the CGM system, the stability of the CGM system across the wear period, and the glucose event alert function. The safety of RIGHTEST CGM will be examined through the number and percentage of subjects experiencing adverse events and examined through symptoms related to the Sensor insertion site.
Time frame: 15 days
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AMCR Institute
Escondido, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Infinite Clinical Trials
Morrow, Georgia, United States
L-MARC Research Center
Louisville, Kentucky, United States
Research Integrity, LLC.
Owensboro, Kentucky, United States
Scott Research,Inc
Laurelton, New York, United States
...and 3 more locations