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

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.

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.