effectiveness and safety of the rightest continuous glucose monitoring system for blood glucose management in persons with diabetes mellitus

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

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.

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.

Eligibility criteria:
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.

Keywords: continuous glucose monitoring