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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RIGHTEST Continuous Glucose Monitoring System — DEVICE
    RIGHTEST 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 System
    Blood 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)

FacilityCityStateZIPSite coordinators
Lakeview Clinical ResearchGuntersvilleAlabama35951-
Novak Clinical ResearchTucsonArizona85741-
Hope Clinical Research LLCCanoga ParkCalifornia91303-
AMCR InstituteEscondidoCalifornia92029-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Infinite Clinical TrialsMorrowGeorgia30274-
L-MARC Research CenterLouisvilleKentucky40213-
Research Integrity, LLC.OwensboroKentucky42303-
Scott Research,IncLaureltonNew York11413-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
Oregon HealthPortlandOregon97239-
The Research Center of the UpstateGreenvilleSouth Carolina29607-

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