Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: All information as provided by CGM system will be masked from subjects and study team during the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, open-label, non-randomized, multicenter, single-arm pivotal study without a control group. In total, 150 subjects with type 1 or type 2 diabetes will be enrolled at 16 investigational sites in the United States. All subjects are required to wear 1 Sensor on the back of each up...
This is a prospective, open-label, non-randomized, multicenter, single-arm pivotal study without a control group. In total, 150 subjects with type 1 or type 2 diabetes will be enrolled at 16 investigational sites in the United States. All subjects are required to wear 1 Sensor on the back of each upper arm for up to 14 days (up to 336 hours) and participate in both study visit and home use portion in this study. All subjects will have venous blood draws for evaluation of the blood glucose reference measurements in in-clinic visits, and to collect accuracy information against a laboratory reference method.
Tracking Information
- NCT #
- NCT04838392
- Collaborators
- Not Provided
- Investigators
- Not Provided
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