Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
Status: Recruiting
Location: See location...
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
Contact Information
Primary
Peng Liu
peng.liu87@outlook.com
0379-64811993
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2025-12-01
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