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

Launched by ASCENSIA DIABETES CARE · Jul 24, 2019

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females, 18 years of age and older
• • People with diabetes (PWD) - type 1 or type 2
• • Ability to speak, read and understand English. Subjects must demonstrate ability to read a paragraph from the first page of the UG to qualify for the study.
• • Willing to complete all study procedures
• Exclusion Criteria:
• • Hemophilia or any other bleeding disorder
• • Pregnancy (self-reported)
• • Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS.
• • Previous participation in a blood glucose monitoring study using the Ascensia's Contour Next (Lightning Next) and Lightning PLUS (L-PLUS or Contour Plus ELITE) BGMS.
• • Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose monitors.
• • Being in this trial during or less than two days since xylose absorption testing (Xylose in the blood is known to cause interference).
• • Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
• • A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk. The reason for exclusion will be clearly documented by investigator or designee on the subject disposition form.