User Performance of the TV4 BGMS

NCT ID: NCT05647824

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 402 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2020-07-23

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).

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

All Subjects

Consists of people with Diabetes and people without Diabetes

Capillary Testing

Intervention Type: DEVICE

Testing Contour Fit BGMS with capillary blood

Alternative Site Testing (AST)

Intervention Type: DEVICE

Testing Contour Fit BGMS using blood from alternative site

Venous Testing

Intervention Type: DEVICE

Testing Contour Fit BGMS with venous blood

Interventions

Capillary Testing

Testing Contour Fit BGMS with capillary blood

Intervention Type: DEVICE

Alternative Site Testing (AST)

Testing Contour Fit BGMS using blood from alternative site

Intervention Type: DEVICE

Venous Testing

Testing Contour Fit BGMS with venous blood

Intervention Type: DEVICE

Other Intervention Names

Contour Fit BGMS; Contour Fit BGMS; Contour Fit BGMS

Eligibility Criteria

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).
• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark P Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Diablo Clinical Research (DCR)

Locations

Diablo Clinical Research (DCR)

Walnut Creek, California, United States

Rocky Mountain Clinical Research, LLC

Idaho Falls, Idaho, United States

Rainier Clinical Research Center Inc

Renton, Washington, United States

Countries

United States

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

GCA-PRO-2019-006-01

Identifier Type: -

Identifier Source: org_study_id