NCT07092761

Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements.

Detailed description

The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements. Up to 42 patients will be enrolled. Each patient will wear two sensors. Interstitial glucose readings from each sensor will be obtained immediatedly following each venous blood sample test. Each participant will make 4 visits to the clinical study site, including the screening visit.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
DEVICE	GS3 CGM	Wearing CGM for a consecutive 14 days

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2025-07-30
• Last updated: 2025-11-20

Locations

1 site across 1 country: China