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

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.