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

NCT ID: NCT04838392

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-11-30

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.

Detailed Description

This is a prospective, open-label, randomized, multicenter, single-arm pivotal study without control groups in up to 150 adult subjects with type 1 or type 2 diabetes mellitus who will be enrolled at 12 investigational sites in the United States.

All subjects are required to wear 1 Sensor on the back of each upper arm for up to 15 days (up to 360 hours) and participate in 4 in-clinic visits. All subjects will have frequent venous blood draws to evaluate the blood glucose reference measurements in each in-clinic visit and collect accurate information against a laboratory reference method.

Conditions

Diabetes Mellitus; Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGM System

Blood 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.

Group Type: EXPERIMENTAL

RIGHTEST Continuous Glucose Monitoring System

Intervention Type: DEVICE

RIGHTEST Continuous Glucose Monitoring System

Interventions

RIGHTEST Continuous Glucose Monitoring System

RIGHTEST Continuous Glucose Monitoring System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Severe diabetes related complications.
• Required or scheduled to have a Magnetic Resonance Imagining (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period.
• Plans to donate blood during the course of the study
• Insulin-dependent type 2 subjects that receive sodium-glucose cotransporter 2 inhibitor (SGLT2 inhibitor) treatment[14]
• Hematocrit (Hct) level lower than the normal reference range
• Weight less than 110 pounds (50 kg)
• Participated in another clinical trial within 2 weeks prior to screening
• Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bionime Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lakeview Clinical Research

Guntersville, Alabama, United States

Novak Clinical Research

Tucson, Arizona, United States

Hope Clinical Research LLC

Canoga Park, California, United States

AMCR Institute

Escondido, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Infinite Clinical Trials

Morrow, Georgia, United States

L-MARC Research Center

Louisville, Kentucky, United States

Research Integrity, LLC.

Owensboro, Kentucky, United States

Scott Research,Inc

Laurelton, New York, United States

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Oregon Health

Portland, Oregon, United States

The Research Center of the Upstate

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

US-312-01

Identifier Type: -

Identifier Source: org_study_id