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

Sponsor
Bionime Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04838392
Collaborator
(none)
150
16
1
7.1
9.4
1.3

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
  • Device: RIGHTEST Continuous Glucose Monitoring System
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

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
All information as provided by CGM system will be masked from subjects and study team during the study.
Primary Purpose:
Treatment
Official Title:
Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Bionime Corporation
ClinicalTrials.gov Identifier:
NCT04838392
Other Study ID Numbers:
  • US-312-01
First Posted:
Apr 9, 2021
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 9, 2021