Status:
NOT_YET_RECRUITING
Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Lead Sponsor:
Bionime Corporation
Conditions:
Diabetes Mellitus
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04838392
Start Date
December 1 2024
End Date
November 1 2025
Last Update
August 1 2024
Active Locations (13)
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1
Lakeview Clinical Research
Guntersville, Alabama, United States, 35951
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