NCT07745244

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jun 2026Dec 2027

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

type1diabetesCGMT1D

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

    15 days

  • System-related Safety

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

    15 days

Study Arms (1)

Adult patients with T1DM

EXPERIMENTAL
Device: GS3 CGM

Interventions

GS3 CGMDEVICE

Wearing CGM for a consecutive 14 days

Adult patients with T1DM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Diagonsed with T1D
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zibo Central Hospital

Zibo, Shandong, 255100, China

RECRUITING

Central Study Contacts

Xiaodong Zhao

CONTACT

0533-3570000xd.zhao26@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 4, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations

CN(1)