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

{ "RIGHTEST Continuous Glucose Monitoring System for Diabetes Management", "This study is testing the RIGHTEST Continuous Glucose Monitoring (CGM) System to see how well and safely it helps adults with type 1 or type 2 diabetes manage their blood sugar. You could join if you are 18 or older and have either type 1 or type 2 diabetes. The main goal is to see how well the RIGHTEST CGM System performs over 15 days. The current recruitment status is unclear, but the study plans to enroll up to 150 participants.", "design": "This is a single-arm study, meaning all participants receive the intervention, and it will include up to 150 adults. It is an open-label study, so both you and the study team will know what intervention you are receiving.", "commitments": "You will wear one sensor on each upper arm for up to 15 days and attend 4 in-clinic visits. During these visits, your glucose levels will be adjusted, and you will have frequent blood draws.", "compensation": "Not stated in the trial record.", "follow_up": "The primary endpoint is measured at 15 days, which suggests the main follow-up period is for this duration.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04838392

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

UNKNOWN
NAAges 18+InterventionalTreatment
Bionime Corporation
~150 participants
Updated 2024-08-01 on ClinicalTrials.gov
What's tested:RIGHTEST Continuous Glucose Monitoring System

At a glance

Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RIGHTEST Continuous Glucose Monitoring System Performance
Measured over 15 days

Conditions

Diabetes Mellitus
Type 1 Diabetes
Type 2 Diabetes

Explore related trials

Diabetes Mellitus

Where it's being run

13 sites across 9 states
California3
Georgia2
Kentucky2
Alabama1
Arizona1
New York1
North Carolina1
Oregon1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • RIGHTEST Continuous Glucose Monitoring System Performance15 days

    The CGM System performance will be primarily evaluated in terms of point and trend accuracy of RIGHTEST™ CGM System continuous interstitial glucose measurements compared to the reference method.