Other Clinical Trial - User Performance of the TV4 BGMS

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Diabetes Mellitus

Clinical Trial Details

NCT number	NCT05647824
Study type	Observational
Source	Ascensia Diabetes Care
Contact
Status	Completed
Phase
Start date	February 5, 2020
Completion date	July 23, 2020

View Details

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