Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
Recruiting now · Not applicable
Conditions studied: Type1diabetes
In brief
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.
Key facts
- Study ID
- NCT07139808
- Run by
- Henan University of Science and Technology
- People needed
- 12
- Starts
- 2025-08-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
- Henan University of Science and Technology — Luoyang, Henan, China (enrolling)
Full record on ClinicalTrials.gov
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