Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)
• Venous blood sampling access can be established in the forearm
• Capable of independently reading instructions and complying with the clinical trial requirements
• Willing to sign the Informed Consent Form (ICF)
Locations
Other Locations
China
Henan University of Science and Technology
RECRUITING
Luoyang
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
Peng Liu
peng.liu87@outlook.com
0379-64811993
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 12
Treatments
Experimental: Adult patients with T1DM
Adult patients with T1DM
Related Therapeutic Areas
Sponsors
Leads: Henan University of Science and Technology