NCT07139808 Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
| NCT ID | NCT07139808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henan University of Science and Technology |
| Condition | Type1diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2025-08-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Spring Instrument (YSI) and Randox reference venous plasma sample measurements.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Hongwei Jiang
PRINCIPAL INVESTIGATOR
Henan University of Science and Technology
Frequently Asked Questions
Who can join the NCT07139808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07139808 currently recruiting?
Yes, NCT07139808 is actively recruiting participants. Contact the research team at peng.liu87@outlook.com for enrollment information.
Where is the NCT07139808 trial being conducted?
This trial is being conducted at Shijiazhuang, China, Luoyang, China.
Who is sponsoring the NCT07139808 clinical trial?
NCT07139808 is sponsored by Henan University of Science and Technology. The principal investigator is Hongwei Jiang at Henan University of Science and Technology. The trial plans to enroll 12 participants.
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