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

NCT ID: NCT07092761

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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. Up to 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.

Conditions

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Type1diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adult patients with T1DM or T2DM

Group Type OTHER

GS3 CGM

Intervention Type DEVICE

Wearing CGM for a consecutive 14 days

Interventions

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GS3 CGM

Wearing CGM for a consecutive 14 days

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Peng Liu

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongwei Jiang

Role: PRINCIPAL_INVESTIGATOR

Henan University of Science and Technology

Locations

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Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Liu

Role: CONTACT

0379-64811993

Facility Contacts

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Peng Liu

Role: primary

Other Identifiers

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SS-KY-CGM-0003

Identifier Type: -

Identifier Source: org_study_id

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