Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus

L-PLUS (Lightning PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and marketed CONTOUR PLUS® test strip. This clinical trial will assess the performance (accuracy) of the L-PLUS meter by lay users with diabetes enrolled as subjects in the study, and by health care professionals (also called study staff). The trial will follow the requirements and procedures described in ISO 15197:2013 International Standard.

This study is designed to satisfy the ISO 15197:2013, Section 8 requirements. The study will be conducted at a minimum of one clinical site and enroll a total of approximately 130 persons with diabetes. For this study, there must be at least 120 evaluable results each for fingerstick and AST self-test results, as well as for staff testing subject fingertip and venous blood using the L-PLUS BGMS. Subject enrollment will continue until the required evaluable samples are collected. The subjects will be 18 years and older. Each subject will make one visit, lasting approximately 1 hour at the clinical site. All subjects will complete the informed consent process before performing any study procedures. All Subjects will be assigned a L-PLUS meter and one Contour Plus test strip lots. The untrained subjects will learn to use the L-PLUS meter by reading the instructional materials. Each subject will perform one fingerstick self-test, one palm test, and staff will perform a fingerstick test on the subject. Subjects will be given a venipuncture and the venous blood will be tested by the study staff with the L-PLUS system. All subject capillary and AST self-test results and study staff fingerstick results will be compared to YSI fingerstick results. Venous blood meter tests will be compared to YSI results of the corresponding venous blood. Hematocrit will be measured for all subjects. All Subjects will then complete a questionnaire (Questionnaire 1) to provide feedback on the meter system and instructions for use.