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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: RIGHTEST Continuous Glucose Monitoring System

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Guntersville, Alabama, United States, 35976
      • Lakeview Clinical Research
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Novak Clinical Research
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC
    • Escondido, California, United States, 92029
      • AMCR Institute
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Miami, Florida, United States, 11373
      • Dr. de Armas Research Center, Llc
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Buford, Georgia, United States, 30518
      • RNA America,LLC
    • Morrow, Georgia, United States, 30274
      • Infinite Clinical Trials
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC.
  • New York
    • Laurelton, New York, United States, 11413
      • Scott Research,Inc
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • The Research Center of The Upstate
  • Texas
    • Humble, Texas, United States, 77338
      • Research Trials WorldWide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
RIGHTEST Glucose Monitoring System Related Adverse Device Effects	The CGM System will be characterized by Adverse Device Effects experienced by study participants.	14 days

Collaborators and Investigators

• Sponsor: Bionime Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: US-312-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes