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PMCF Study of GX-01S CGM in Adults With Diabetes

NCT07802327 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-09-03

No results posted yet for this study

Summary

This clinical study evaluates the GX-01S Continuous Glucose Monitoring (CGM) System in adults with Type 1 or Type 2 diabetes. CGM systems measure glucose levels continuously throughout the day, providing real-time information that can help patients manage their diabetes more effectively.

The study aims to determine whether using the GX-01S CGM System improves glycemic control, as measured by Time in Range (the percentage of time glucose levels stay within a target range). It will also assess safety, treatment satisfaction, quality of life, and ease of use of the device.

Participants will wear the GX-01S CGM System for approximately 135 days (about 4.5 months). The first 15 days will be a "blinded" period where participants cannot see their glucose readings, which will be used to establish a baseline. For the remaining 120 days, participants will have full access to their real-time glucose data. Participants will visit the study site at the beginning, Day 15, Day 45, and Day 135 for assessments and questionnaires.

The study will enroll 100 adult patients across multiple centers in Europe. Enrollment is expected to begin in September 2026.

Conditions

Interventions

DEVICE

GX-01S Continuous Glucose Monitoring System

The GX-01S CGM System is a single-use, real-time continuous glucose monitoring device designed to provide interstitial glucose readings for the management of diabetes. The system consists of three primary components: (1) a sterile sensor with an integrated applicator, (2) a transmitter for wireless data transfer, and (3) the LinX mobile application for real-time display and alert management. The sensor is designed for a wear life of up to 15 days and provides glucose readings every minute. The system includes customizable alerts for high/low glucose levels and allows for remote data sharing through the Pancares Web Portal.

Sponsors & Collaborators

  • MicroTech Medical（Hangzhou）Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Julia Mader, Professor, M.D. · Medical University of Graz

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-02-29
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802327 on ClinicalTrials.gov