Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Bionime Corporation
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceRIGHTEST Continuous Glucose Monitoring System
RIGHTEST Continuous Glucose Monitoring System
Locations (13)
- Lakeview Clinical ResearchGuntersville, Alabama
- Novak Clinical ResearchTucson, Arizona
- Hope Clinical Research LLCCanoga Park, California
- AMCR InstituteEscondido, California
- Diablo Clinical Research, Inc.Walnut Creek, California
- Atlanta Diabetes AssociatesAtlanta, Georgia