Actively Recruiting
Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
Led by Henan University of Science and Technology · Updated on 2026-04-07
12
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Diagnosed with type 1 diabetes mellitus and using continuous subcutaneous insulin infusion (CSII)
- Able to have venous blood sampling access in the forearm
- Capable of reading instructions independently and following clinical trial requirements
- Willing to sign the Informed Consent Form (ICF)
You will not qualify if you...
- Severe hypoglycemia within the past 6 months
- Diabetic ketoacidosis (DKA) diagnosed in the past 3 months
- Heart failure or hemiplegic effects from previous cerebrovascular disease
- Severe skin conditions at the sensor wear site
- Extensive systemic skin disorders
- Problems with wound healing, bleeding disorders, or use of anticoagulant medications
- Anemia or abnormal hematocrit levels
- Blood donation within the past 6 months
- Pregnancy, breastfeeding, or plans for pregnancy within 30 days
- Current or recent participation (within 1 month) in other clinical trials
- Planned MRI or CT scans during sensor wear
- Allergy to medical adhesives or alcohol
- Conditions affecting understanding of informed consent or study procedures
- Any other conditions that the investigator considers exclusionary
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
2
Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
Research Team
P
Peng Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here