NCT07139808

Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (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 continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.

Detailed description

The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring (CGKM) system among adult patients with type 1 diabetes mellitus with respect to YSI and Randox reference venous plasma sample measurements. Up to 14 patients will be enrolled. Interstitial glucose and ketone readings from the sensors will be obtained immediatedly following each venous blood sample test. Each participant will make 3 visits to the clinical study site, including the screening visit.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
DEVICE	GK5 CGKM	Wear for a consecutive 15 days

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-08-24
• Last updated: 2026-04-07

Locations

2 sites across 1 country: China