NCT05806554

Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 159 (actual)
• Sponsor: Sinocare · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.

Detailed description

Participants will attend a screening visit, 4 clinic visits with Frequent Sampling Testing (FST) at the beginning, 2 in the middle, and end of the I3 CGM sensor wear, and a visit for removal of the I3 CGM. Participants will wear 3 I3 CGM devices for up to 15 days and be instructed to continue their normal daily activities and manage their glucose as usual between in clinic FST per routine care. Participants will not have access to the I3 CGM data for the management of their blood glucose between clinic visits and will continue their usual care including CGM, if they are CGM users. At the clinic FST visits venous blood samples will be drawn from an intravenous cannula for FST for up to 10 hours for plasma glucose determination. During the clinic visits the investigative site staff will determine the participants' insulin doses and meals and may induce both hypoglycemia and hyperglycemia of up to an hour duration.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitoring device	Continuous glucose monitoring device

Timeline

• Start date: 2023-07-19
• Primary completion: 2024-06-13
• Completion: 2024-10-22
• First posted: 2023-04-10
• Last updated: 2025-11-25

Locations

6 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study