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

NCT07092761 | Recruiting

• 1 other identifier: SS-KY-CGM-0003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• System performance

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

  14 days

• System-related Safety

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

  14 days

Study Arms (1)

Adult patients with T1DM or T2DM

OTHER

Device: GS3 CGM

Interventions

GS3 CGM DEVICE

Wearing CGM for a consecutive 14 days

Adult patients with T1DM or T2DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Science and Technology: lead

Study Sites (1)

Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Study Officials

• Hongwei Jiang

  Henan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Liu

CONTACT

0379-64811993; peng.liu87@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)