User Performance of the TV4 BGMS

NCT05647824 | Completed FDA Device

• 1 other identifier: GCA-PRO-2019-006-01
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  4 weeks

• Venous Blood Test: Obtain TV4 BGMS performance data using venous blood from lay users with diabetes.

  4 weeks

• Subject Questionnaire on the Usability of TV4 BGMS

  4 weeks

Study Arms (1)

All Subjects

Consists of people with Diabetes and people without Diabetes

Device: Capillary Testing; Device: Alternative Site Testing (AST); Device: Venous Testing

Interventions

Capillary Testing DEVICE

Testing Contour Fit BGMS with capillary blood

Also known as: Contour Fit BGMS

All Subjects

Alternative Site Testing (AST) DEVICE

Testing Contour Fit BGMS using blood from alternative site

Also known as: Contour Fit BGMS

All Subjects

Venous Testing DEVICE

Testing Contour Fit BGMS with venous blood

Also known as: Contour Fit BGMS

All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (3)

Diablo Clinical Research (DCR)

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Clinical Research, LLC

Idaho Falls, Idaho, 83404, United States

Location

Rainier Clinical Research Center Inc

Renton, Washington, 98057, United States

Location

Related Publications (3)

• Protection of laboratory workers from occupationally acquired infections; approved guideline - third edition. CLSI document M29-A3. ISBN1-56238-567-4.

  BACKGROUND

• Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008. CDC.

  BACKGROUND

• FDA, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2, 2011.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark P Christiansen, MD

  Diablo Clinical Research (DCR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 13, 2022
• Study Start: February 5, 2020
• Primary Completion: March 20, 2020
• Study Completion: July 23, 2020
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

US (3)