Clinical trial NCT04033315: Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus
Official title: User Performance of the L-PLUS Blood Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: diabetes
BGMS
blood glucose monitoring system
fingerstick
AST self-test
YSI Glucose Analyzer
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will be assigned to use the L-PLUS meter
Primary purpose: SUPPORTIVE_CARE

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 (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.

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.

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.

Primary outcomes:
measure: Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test
timeFrame: Day 1
Secondary outcomes:
measure: Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST)
timeFrame: Day 1
measure: Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood
timeFrame: Day 1
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
Study officials:
References: