User Performance of the Thunder Plus BGMS

T-PLUS (Thunder PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and CONTOUR PLUS test strips. The meter can wirelessly transmit BG results using Bluetooth® Low Energy technology to the meter mobile application that will be available on specified versions of the iOS and Android mobile platforms. This clinical trial will assess the performance (accuracy) of the T-PLUS meters by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).

This study is designed to satisfy both the FDA SMBG:2018 and the ISO 15197:2013, Section 8 requirements. Besides different analysis criteria, the main difference between these regulations is that FDA SMBG:2018 requires that both naïve users (people without diabetes) and people with diabetes to be included in the study population. The ISO 15197:2013 standard states that the study population shall only include people with diabetes. The study will be conducted at one clinical site and enroll approximately 370 lay users. Ten to fifteen percent (10-15%) of the enrolled subjects will be people without diabetes and twenty percent (20%) of subjects enrolled with diabetes will have Type 1 diabetes. Each subject will make one visit, lasting approximately 1 hour at the clinical site. Study sessions will be conducted by study staff members who have been trained on all aspects of the protocol. PROCEDURES: Subjects will be assigned to use the T-PLUS meter and use one lot of Contour Plus test strip lots throughout the visit. • Additional Procedures for Subjects with Diabetes: Subjects with diabetes will be given a venipuncture. The venous blood will be tested by the study staff using the T-PLUS system, and the YSI lab analyzer. After all self-testing is completed, subjects with diabetes will be given a questionnaire to provide feedback about the new features of the system.