NCT05348928

A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study

A Pilot Study of the Feasibility and Accuracy of the TrueVie Continuous Glucose Monitoring System - A Non-Significant Risk Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Sinocare Meditech Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.

Detailed description

After being informed about the study and potential risks, all participants giving written informed consent will be screened for participation. Qualifying participants will insert CGM sensors and come to 3 clinic visits at the beginning, middle and end of the 15 days intended sensor life. At the clinic visits participants are served two meals and perform a brief period of exercise of moderate intensity while blood samples are drawn according to a planned schedule timed to coincide with the TrueVie measurements.

Conditions

• Continuous Glucose Monitoring

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitoring device	Continuous glucose monitoring device
OTHER	Laboratory plasma glucose concentration determination	Laboratory plasma glucose concentration determination

Timeline

• Start date: 2022-05-04
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2022-04-27
• Last updated: 2022-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study