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User Performance of the TV4 BGMS | Clinical Trials | Clareo Health

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User Performance of the TV4 BGMS

User Performance of the TV4 Blood Glucose Monitoring System

NCT05647824•Ascensia Diabetes Care

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (3)

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

Key Dates

Start Date

February 5, 2020

Primary Completion Date

March 20, 2020

Completion Date

July 23, 2020

Last Updated

February 2, 2023

Enrollment

402

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

Capillary Testing

DEVICE

Alternative Site Testing (AST)

DEVICE

Venous Testing

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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