Clinical trial NCT04838392: Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Official title: Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Type 1 Diabetes
Type 2 Diabetes
Keywords: Continuous Glucose Monitoring
Lead sponsor: Bionime Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: RIGHTEST Continuous Glucose Monitoring System Performance
timeFrame: 15 days
Secondary outcomes:
measure: To investigate the RIGHTEST Glucose Monitoring System other system performance and safety
timeFrame: 15 days
Other outcomes:
Locations:
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Tucson
country: United States
facility: Novak Clinical Research
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research LLC
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Morrow
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC.
state: Kentucky
city: Laurelton
country: United States
facility: Scott Research,Inc
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Portland
country: United States
facility: Oregon Health
state: Oregon
city: Greenville
country: United States
facility: The Research Center of the Upstate
state: South Carolina
Study officials:
References: