RecruitingNot ApplicableNCT07139808

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

Sponsor

Henan University of Science and Technology

Enrollment

12 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Type1diabetes

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

Min Age: 18 Years

Inclusion Criteria5

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)

Exclusion Criteria14

Severe hypoglycemia within the past 6 months
A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
Severe skin conditions at the sensor wear site
Extensive systemic skin disorders
Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications
Anemia or abnormal hematocrit
Blood donation within the past 6 months
Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
Current or recent (≤1 month) participation in other clinical trials
Planned MRI/CT scans during sensor wear
Allergy to medical adhesives or alcohol
Conditions impairing comprehension of informed consent or study procedures
Other exclusionary conditions per investigator's discretion