NCT05647824

User Performance of the TV4 BGMS

User Performance of the TV4 Blood Glucose Monitoring System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 402 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DEVICE	Capillary Testing	Testing Contour Fit BGMS with capillary blood
DEVICE	Alternative Site Testing (AST)	Testing Contour Fit BGMS using blood from alternative site
DEVICE	Venous Testing	Testing Contour Fit BGMS with venous blood

Timeline

• Start date: 2020-02-05
• Primary completion: 2020-03-20
• Completion: 2020-07-23
• First posted: 2022-12-13
• Last updated: 2023-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study