Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed 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 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CGM System Blood draw and glucose challenge will be performed to evaluate performance of CGM system compared to reference measurement during in in-clinic visits. |
Device: RIGHTEST Continuous Glucose Monitoring System
RIGHTEST Continuous Glucose Monitoring System
|
Outcome Measures
Primary Outcome Measures
- RIGHTEST Continuous Glucose Monitoring System Performance [14 days]
The CGM System performance will be evaluated in terms of point and trend accuracy of CGM System readings comparted to the reference measurements.
Secondary Outcome Measures
- RIGHTEST Glucose Monitoring System Related Adverse Device Effects [14 days]
The CGM System will be characterized by Adverse Device Effects experienced by study participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must be at least 18 years of age.
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Subjects must have type 1 or type 2 diabetes mellitus.
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Subjects must be available to participate in all study visits.
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Willing to wear 1 Sensor on each upper arm simultaneously.
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Subjects must be willing and able to provide signed written consent.
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Subjects must be able to read and understand the device instructions.
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Subjects must be able to speak, read and write English.
Exclusion Criteria:
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Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
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Extensive skin changes or diseases at the proposed application sites.
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Subjects who have or are:
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Pregnant,
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A hematocrit level >37%,
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A condition requiring or likely requiring magnetic resonance imaging (MRI), computerized tomography (CT) or diathermy scheduled during the study,
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Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study.
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Unsuitable for participation due to any other cause as determined by the Investigator.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Lakeview Clinical Research | Guntersville | Alabama | United States | 35976 |
2 | Novak Clinical Research | Tucson | Arizona | United States | 85741 |
3 | Hope Clinical Research, LLC | Canoga Park | California | United States | 91303 |
4 | AMCR Institute | Escondido | California | United States | 92029 |
5 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
6 | Dr. De Armas Research Center, LLC | Miami | Florida | United States | 11373 |
7 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30318 |
8 | RNA America,LLC | Buford | Georgia | United States | 30518 |
9 | Infinite Clinical Trials | Morrow | Georgia | United States | 30274 |
10 | L-MARC Research Center | Louisville | Kentucky | United States | 40213 |
11 | Research Integrity, LLC. | Owensboro | Kentucky | United States | 42303 |
12 | Scott Research,Inc | Laurelton | New York | United States | 11413 |
13 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
14 | Oregon Health | Portland | Oregon | United States | 97239 |
15 | The Research Center of the Upstate | Greenville | South Carolina | United States | 29607 |
16 | Research Trials WorldWide | Humble | Texas | United States | 77338 |
Sponsors and Collaborators
- Bionime Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- US-312-01