Status:
COMPLETED
Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
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 (a...
Detailed Description
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 diabet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04033315
Start Date
July 15 2019
End Date
September 5 2019
Last Update
June 13 2024
Active Locations (1)
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1
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057