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

May 17, 2024 updated by: Ascensia Diabetes Care

User Performance of the L-PLUS Blood Glucose Monitoring System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Untrained Subjects with Diabetes use the L-PLUS BGMS
Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma.
Device: L-PLUS meter
Blood Glucose Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test
Time Frame: Day 1
Accuracy of BGMS test with fingerstick blood. The results of the fingerstick meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST)
Time Frame: Day 1
Accuracy of BGMS test with palm blood. The results of the palm blood meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria
Day 1
Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood
Time Frame: Day 1
Accuracy of BGMS using venous blood compared to the reference analyzer for all subjects using pre-specified accuracy criteria
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascensia Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

September 5, 2019

Study Completion (Actual)

September 5, 2019

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCA-PRO-2019-002-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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