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

NCT04033315 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-06-13

Study results available
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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.

Conditions

Interventions

DEVICE

L-PLUS meter

Blood Glucose Monitoring System

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2019-09-05
Completion
2019-09-05

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033315 on ClinicalTrials.gov