New real-time continuous glucose monitor accuracy and safety in adults with type 1 diabetes
Official title: Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System
Run by Henan University of Science and Technology · NCT07092761 · Data updated 2026-11-12
This project will test a new real-time continuous glucose monitor to see if its sensor readings match lab venous plasma (YSI) measurements in adults with type 1 diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | Henan University of Science and Technology Academic / other |
| Locations | 1 site (Luoyang, Henan) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07092761 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with type 1 diabetes who can undergo forearm venous blood sampling, follow study instructions independently, and attend four clinic visits are ideal candidates.
✕Probably not a fit
People with recent severe hypoglycemia, active or extensive skin conditions at the sensor site, coagulation or hematologic abnormalities, pregnancy or lactation, inability to provide forearm venous access, or planned imaging/MRI during wear are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial will enroll up to 42 adults with type 1 diabetes who will each wear two sensors of the GS3 continuous glucose monitoring system. Interstitial glucose readings from each sensor will be obtained immediately following venous blood samples measured by the YSI reference method to compare accuracy. Each participant will make four clinic visits, including a screening visit, and safety data will be collected alongside performance data. The protocol focuses on paired sensor-to-reference comparisons and monitoring for adverse device effects.
Why it matters
Potential benefit: If successful, the device could provide people with type 1 diabetes more accurate real-time glucose readings, helping improve glucose management and reduce the risk of hypo- or hyperglycemia.
How similar studies have gone: Comparable continuous glucose monitoring devices have previously shown good agreement with YSI venous reference measurements, so the testing approach is well established though the specific device is new.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagonsed with T1DM or T2DM * 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 month * Heart failure or hemiplegic sequelae due to prior cerebrovascular disease * Severe skin conditions at the sensor wear site * Extensive systemic skin disorders * Coagulation disorders confirmed by the investigator * 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's running
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Henan University of Science and Technology
Luoyang, Henan, China Recruiting
Study contacts
- Principal investigator: Hongwei Jiang — Henan University of Science and Technology
- Study coordinator: Peng Liu
- Email: peng.liu87@outlook.com
- Phone: 0379-64811993
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.