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RecruitingNCT07092761Updated May 29, 2026

Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System

An interventional study of GS3 CGM in Type1diabetes, sponsored by Henan University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Henan University of Science and Technology · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Apr 2025, registered Jul 2025).
  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements.

Read the detailed description

The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements. No less than 42 patients will be enrolled. Each patient will wear two sensors. Interstitial glucose readings from each sensor will be obtained immediatedly following each venous blood sample test. Each participant will make 4 visits to the clinical study site, including the screening visit.

02

Conditions studied

  • Type1diabetes
03

In context

Lead sponsor

Henan University of Science and Technology is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

  • Other
    Adult patients with T1DM or T2DM

    Device: GS3 CGM

Interventions

  • DeviceGS3 CGM

    Wearing CGM for a consecutive 14 days

06

What researchers measure

Primary outcomes

  1. System performance

    The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements

    Time frame: 14 days

  2. System-related Safety

    The CGM system will be characterized by adverse device effects experienced by the study participants

    Time frame: 14 days

07

Study locations

1 of 1 sites recruiting
  • Henan University of Science and Technology
    Luoyang, Henan 471003, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07092761
Lead sponsor
Henan University of Science and Technology
Responsible party
Peng Liu (Physician, The First Affiliated Hospital of Henan University of Science and Technology) — Principal investigator
First posted
Jul 30, 2025
Start date
Apr 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
May 29, 2026

Study contacts

Peng Liu
Contact
peng.liu87@outlook.com
0379-64811993
Hongwei Jiang
principal investigator · Henan University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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