Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04838392
• Other study ID #: US-312-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: February 2022

Study information

• Verified date: April 2021
• Source: Bionime Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must be at least 18 years of age.

• Subjects must have type 1 or type 2 diabetes mellitus.

• Subjects must be available to participate in all study visits.

• Willing to wear 1 Sensor on each upper arm simultaneously.

• Subjects must be willing and able to provide signed written consent.

• Subjects must be able to read and understand the device instructions.

• Subjects must be able to speak, read and write English.

Exclusion Criteria:

• Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.

• Extensive skin changes or diseases at the proposed application sites.

• Subjects who have or are:

• Pregnant,

• A hematocrit level >37%,

• A condition requiring or likely requiring magnetic resonance imaging (MRI), computerized tomography (CT) or diathermy scheduled during the study,

• Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study.

• Unsuitable for participation due to any other cause as determined by the Investigator.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• RIGHTEST Continuous Glucose Monitoring System
RIGHTEST Continuous Glucose Monitoring System

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	RNA America,LLC	Buford	Georgia
United States	Hope Clinical Research, LLC	Canoga Park	California
United States	AMCR Institute	Escondido	California
United States	The Research Center of the Upstate	Greenville	South Carolina
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	Research Trials WorldWide	Humble	Texas
United States	Scott Research,Inc	Laurelton	New York
United States	L-MARC Research Center	Louisville	Kentucky
United States	Dr. De Armas Research Center, LLC	Miami	Florida
United States	Infinite Clinical Trials	Morrow	Georgia
United States	Research Integrity, LLC.	Owensboro	Kentucky
United States	Oregon Health	Portland	Oregon
United States	Novak Clinical Research	Tucson	Arizona
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bionime Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RIGHTEST Continuous Glucose Monitoring System Performance	The CGM System performance will be evaluated in terms of point and trend accuracy of CGM System readings comparted to the reference measurements.	14 days
Secondary	RIGHTEST Glucose Monitoring System Related Adverse Device Effects	The CGM System will be characterized by Adverse Device Effects experienced by study participants.	14 days