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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is a prospective, open-label, non-randomized, multicenter, single-arm pivotal study without a control group. In total, 150 subjects with type 1 or type 2 diabetes will be enrolled at 16 investigational sites in the United States. All subjects are required to wear 1 Sensor on the back of each upper arm for up to 14 days (up to 336 hours) and participate in both study visit and home use portion in this study. All subjects will have venous blood draws for evaluation of the blood glucose reference measurements in in-clinic visits, and to collect accuracy information against a laboratory reference method.

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

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: RIGHTEST Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be at least 18 years of age. Subjects must have type 1 or type 2 diabetes mellitus. Subjects must be available to participate in all study visits. Willing to wear 1 Sensor on each upper arm simultaneously. Subjects must be willing and able to provide signed written consent. Subjects must be able to read and understand the device instructions. Subjects must be able to speak, read and write English. Exclusion Criteria: Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. Extensive skin changes or diseases at the proposed application sites. Subjects who have or are: Pregnant, A hematocrit level >37%, A condition requiring or likely requiring magnetic resonance imaging (MRI), computerized tomography (CT) or diathermy scheduled during the study, Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study. Unsuitable for participation due to any other cause as determined by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM System<br>Blood draw and glucose challenge will be performed to evaluate performance of CGM system compared to reference measurement during in in-clinic visits. | Device: RIGHTEST Continuous Glucose Monitoring System<br>* RIGHTEST Continuous Glucose Monitoring System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RIGHTEST Continuous Glucose Monitoring System Performance | The CGM System performance will be evaluated in terms of point and trend accuracy of CGM System readings comparted to the reference measurements. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RIGHTEST Glucose Monitoring System Related Adverse Device Effects | The CGM System will be characterized by Adverse Device Effects experienced by study participants. | 14 days |