Bionime Corporation
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.
Inclusion Criteria: * Subjects must be 18 years and older * Subjects must have a diagnosis of type 1 or type 2 diabetes mellitus * Subjects must be available to participate in all clinical sessions with the following parameters: * Subject must be willing to wear 1 sensor on each upper arm simultaneously. * Subjects must be willing to have their glucose levels manipulated in each in-clinic visit. * Subjects must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. * Subjects must be willing and able to provide signed…
RIGHTEST Continuous Glucose Monitoring System