Status:
RECRUITING
Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
Lead Sponsor:
Henan University of Science and Technology
Conditions:
Type1diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 S...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07139808
Start Date
August 1 2025
End Date
December 1 2025
Last Update
August 24 2025
Active Locations (1)
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1
Henan University of Science and Technology
Luoyang, Henan, China, 471003