Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
1 other identifier
interventional
150
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Dec 2024
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedAugust 1, 2024
July 1, 2024
7 months
March 29, 2021
July 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RIGHTEST Continuous Glucose Monitoring System Performance
The CGM System performance will be primarily evaluated in terms of point and trend accuracy of RIGHTEST™ CGM System continuous interstitial glucose measurements compared to the reference method.
15 days
Secondary Outcomes (1)
To investigate the RIGHTEST Glucose Monitoring System other system performance and safety
15 days
Study Arms (1)
CGM System
EXPERIMENTALBlood 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.
Interventions
RIGHTEST Continuous Glucose Monitoring System
Eligibility Criteria
You may qualify if:
- 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 written consent.
- Subjects must be able to speak, read and write English.
You may not qualify if:
- Known allergy and not able to tolerate to medical grade tape adhesive.
- Presence and unresolved of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- Subjects who have or are female of child-bearing potential age:
- Has a positive pregnancy screening test
- That plans to become pregnant during the course of study.
- Diagnosed with hemophilia or any other bleeding disorders
- Acute or chronic kidney disease
- Currently managed by dialysis or anticipating initiating dialysis during the course of study.
- Current or know history of coronary artery or cardiovascular disease that is not stable with medical management thromboembolic disease.
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose excessive risk to study staff.
- Prior to enrollment, subject has had:
- Severe hypoglycemia within past 6 months.
- History of Diabetic Ketoacidosis (DKA) within the past 6 months,
- History of a seizure disorder within the last 6 month
- Hypoglycemia unawareness.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Lakeview Clinical Research
Guntersville, Alabama, 35951, United States
Novak Clinical Research
Tucson, Arizona, 85741, United States
Hope Clinical Research LLC
Canoga Park, California, 91303, United States
AMCR Institute
Escondido, California, 92029, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Infinite Clinical Trials
Morrow, Georgia, 30274, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Research Integrity, LLC.
Owensboro, Kentucky, 42303, United States
Scott Research,Inc
Laurelton, New York, 11413, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Oregon Health
Portland, Oregon, 97239, United States
The Research Center of the Upstate
Greenville, South Carolina, 29607, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All information as provided by CGM system will be masked from subjects and study team during the study.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 9, 2021
Study Start
December 1, 2024
Primary Completion
July 1, 2025
Study Completion
November 1, 2025
Last Updated
August 1, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share