N/A
Completed N=130
Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus
Source: ClinicalTrials.gov NCT04033315 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test — 127 Participants
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 (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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test |
127 | — |
| SECONDARY Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST) |
119 | — |
| SECONDARY Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood |
129 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04033315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.