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

Bionime

Status: Not yet enrolling

Conditions: Type 1 Diabetes; Diabetes Mellitus; Type 2 Diabetes

Treatments: Device: RIGHTEST Continuous Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04838392

US-312-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

CGM System

Experimental group

Description:

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.

Treatment:

Device: RIGHTEST Continuous Glucose Monitoring System