Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Part of paid clinical trials in Guntersville, Alabama.
- Sponsor
- Bionime Corporation
- Study ID
- NCT04838392
- Status
- Not Yet Recruiting
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Conditions
- Diabetes Mellitus
- Type 1 Diabetes
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RIGHTEST Continuous Glucose Monitoring System — DEVICERIGHTEST Continuous Glucose Monitoring System
Study Details
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.
Key Dates
- Start date
- Dec 31, 2024
- Status verified
- Jul 2024
- Primary completion
- Jul 31, 2025
- Completion
- Nov 30, 2025
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CGM SystemBlood draw and glucose challenge will be performed to evaluate the performance of the CGM system compared to reference measurements during the in in-clinic visits.
Primary Outcome Measure
RIGHTEST Continuous Glucose Monitoring System Performance [ Time Frame: 15 days ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lakeview Clinical Research | Guntersville | Alabama | 35951 | - |
| Novak Clinical Research | Tucson | Arizona | 85741 | - |
| Hope Clinical Research LLC | Canoga Park | California | 91303 | - |
| AMCR Institute | Escondido | California | 92029 | - |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | - |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | - |
| Infinite Clinical Trials | Morrow | Georgia | 30274 | - |
| L-MARC Research Center | Louisville | Kentucky | 40213 | - |
| Research Integrity, LLC. | Owensboro | Kentucky | 42303 | - |
| Scott Research,Inc | Laurelton | New York | 11413 | - |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | - |
| Oregon Health | Portland | Oregon | 97239 | - |
| The Research Center of the Upstate | Greenville | South Carolina | 29607 | - |
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