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

Launched by BIONIME CORPORATION · Apr 6, 2021

Keywords

ClinConnect Summary

The RIGHTEST Continuous Glucose Monitoring (CGM) System clinical trial is designed to see how well this new device helps adults with diabetes manage their blood sugar levels. This study will include people with both type 1 and type 2 diabetes, and it aims to find out if using this monitoring system is safe and effective. If you're at least 18 years old and have been diagnosed with diabetes, you might be eligible to participate. However, there are some important factors to consider, such as being able to wear sensors on your arms and being willing to attend all study visits.

Participants in this trial will have their glucose levels monitored closely, and they will need to follow specific instructions from the study team. It's important to note that some people may not be able to join, especially those with certain health conditions or allergies related to medical tape. If you think you might be interested in helping with this research, you'll need to be able to read, write, and speak English, and provide written consent to participate. Overall, this trial could provide valuable information about a new tool that may help improve the lives of people living with diabetes.

Gender

ALL

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.