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

NCT04033315 | Completed Results

• 1 other identifier: GCA-PRO-2019-002-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

diabetes; BGMS; blood glucose monitoring system; fingerstick; AST self-test; YSI Glucose Analyzer

Outcome Measures

Primary Outcomes (1)

• Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test

  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 Outcomes (2)

• Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST)

  Day 1

• Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood

  Day 1

Study Arms (1)

Untrained Subjects with Diabetes use the L-PLUS BGMS

EXPERIMENTAL

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

Interventions

L-PLUS meter DEVICE

Blood Glucose Monitoring System

Untrained Subjects with Diabetes use the L-PLUS BGMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jane Wallace
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

5748501467

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be assigned to use the L-PLUS meter

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: July 15, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-05

Locations

US (1)