User Performance of the TV4 BGMS

User Performance of the TV4 Blood Glucose Monitoring System

Thunder V4 (TV4) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and new Contour FIT test strips. This clinical trial will assess the performance (accuracy) of the TV4 meter by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Capillary Testing; Device: Alternative Site Testing (AST); Device: Venous Testing

Detailed Description

The study will be conducted at three clinical sites and enroll a total of approximately 402 lay users. Ten to fifteen percent (10 - 15%) of the enrolled subjects will be naïve users (naïve to SMBG's and may include people without diabetes). At least twenty percent (20%) of subjects enrolled with diabetes will have Type 1 diabetes. At least 70% of subjects will be younger than age 65. Sites will also enroll subjects of Chinese descent.

This clinical investigation will be conducted within the US.

• Study Type: Observational
• Enrollment (Actual): 402

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research (DCR)
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research, LLC
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The following population criteria are study goals, with each site recruiting to meet these goals:

1. Enrollment: A total of at least 402 subjects across the sites, or it can also be 134 per clinical site.
2. At least 70% of all subjects will be younger than age 65 (across all the sites).
3. Ten to fifteen % (10-15%) of naïve users (naïve to SMBG's and may include people without diabetes) (across all the sites).
4. At least 20% of non-naïve users (subjects with diabetes) will have type 1 diabetes (across all the sites).
5. Sites will also recruit subjects of Chinese descent according to the site's ability. (One or both of the subject's parents can be of Chinese descent.)

Description

Inclusion Criteria:

• Males and females, 18 years of age and older
• Ability to speak, read and understand English. Subjects must demonstrate the ability to read a paragraph from the first page of the User Guide (UG) to qualify for the study.
• Willing to complete all study procedures

Exclusion Criteria:

• Subjects without diabetes that are not naïve to Blood Glucose Monitoring System.
• 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 use of the Ascensia Contour Thunder V3 (TV3), or Thunder PLUS (T-PLUS), or Thunder V4 (TV4) BGMS.
• Working for a medical laboratory, hospital or another clinical setting that involves training on, or clinical use of blood glucose monitors.
• Being in this trial during or soon after xylose absorption testing (Xylose in the blood is known to cause interference). However, subjects can be enrolled as soon as 2 days after the test is performed (25 gms of oral xylose administered during this test is cleared within 480 mins or 8 hours).

• 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.

  • Immediate family members are the subject's parents, spouse, children, and siblings, including the parent's spouse; step-children and adopted children and their spouses.
  • A competitive medical device company is a company that provides a medical device or components of a device that is related to diabetes. For example, people who are not eligible are those who work for companies that create or manufacture the following (or a company that is in a partnership with a company that provides such devices): lancing devices, blood glucose monitoring systems, continuous glucose monitoring systems, insulin pens, or systems related to the measurement of HbA1c.

People who are eligible are those who work for companies associated with products such as wound dressings, medications or dietary products.

- 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Subjects; Consists of people with Diabetes and people without Diabetes	Device: Capillary Testing; Testing Contour Fit BGMS with capillary blood; Other Names: Contour Fit BGMS; Device: Alternative Site Testing (AST); Testing Contour Fit BGMS using blood from alternative site; Other Names: Contour Fit BGMS; Device: Venous Testing; Testing Contour Fit BGMS with venous blood; Other Names: Contour Fit BGMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fingerstick Test: Obtain TV4 BGMS performance data in the hands of lay users with diabetes using fingerstick capillary blood obtained with Microlet NEXT® lancing device.	Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alternative Site Test (AST): Obtain TV4 BGMS performance data in the hands of lay users with diabetes using capillary blood from the palm site obtained with Microlet NEXT lancing device with the AST endcap.	Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL	4 weeks
Venous Blood Test: Obtain TV4 BGMS performance data using venous blood from lay users with diabetes.	Number of glucose results falling within ±15mg/dL of laboratory method at glucose concentration <100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL	4 weeks
Subject Questionnaire on the Usability of TV4 BGMS	Number of results with scores of 3 or higher to statements concerning instructions for use or ease of use. Scores of 3 or greater (on a scale of 0 to 5) are more favorable to usability.	4 weeks

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Mark P Christiansen, MD, Diablo Clinical Research (DCR)

Publications and helpful links

General Publications

• Protection of laboratory workers from occupationally acquired infections; approved guideline - third edition. CLSI document M29-A3. ISBN1-56238-567-4.
• Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008. CDC.
• FDA, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2, 2011.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): July 23, 2020

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GCA-PRO-2019-006-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes