Trial Outcomes & Findings for User Study for Enhanced Meter Feature (NCT NCT01889355)

5.5 Evaluation Procedure The evaluation shall be performed in the following sequence and be supervised by one or more healthcare providers trained in the use of the device under evaluation (ISO 15197:2013 8.1). 1. Briefly describe to the subject that the goal of this study is to obtain a blood glucose reading, describe the study procedures, and obtain written informed consent ensuring all questions are answered. 2. For each consenting study subject, assign a sequential User ID number and obtain inclusion criteria, exclusion criteria, and user demographics. 3. Perform a urine pregnancy test for women of childbearing potential if pregnancy status unknown. 4. Locate subjects to a private area where they are not able to see others performing the test. 5. The trained technician will put on a new pair of gloves. 6. Provide the subject with an AgaMatrix meter, test strips, the system kit lancing device and lancets. Prior to performing self-testing, each study subject shall

n=113 Participants

Age group ranged from ages 18-86, Male and female with both Type 1 and Type 2 diabetics. Race was both white, black/African American and Hispanic who are able to read and understand English per the subject consent form.

n=50 Participants

This clinical study will consist of at least 50 evaluable subjects who meet all inclusion/exclusion criteria. Subjects shall be selected using the consecutive sampling method. All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system (e.g. packed cell volume within the system's specified limits), and applicable regulatory requirements (e.g. written informed consent), shall be eligible to participate in the study (ISO 15197:2013 8.3). 3.2 Inclusion Criteria Potential participants may be enrolled in the study if they satisfy the following inclusion criteria: IC 1. Age of subject is 18 years or older IC 2. Has been diagnosed with Type1 or Type 2 diabetes IC 3. Able to speak and read English proficiently IC 4. Must be physically able to self-test 3.3 Exclusion Criteria Potential subjects who display any o