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NCT07802327

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

Sponsor: MicroTech Medical（Hangzhou）Co.,Ltd.

View on ClinicalTrials.gov

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.

Official title: PROspective Post-Market Clinical Follow-Up (PMCF) Study to Assess the Clinical Benefits of the GX-01S Continuous Glucose Monitoring System in Adult Patients With Diabetes Type 1 and Type 2

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09

Completion Date

2028-06

Last Updated

2026-09-03

Healthy Volunteers

Conditions

Diabetes Mellitus Diabetes Mellitus ( Type 1 and Type 2)

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.

Inclusion Criteria: \- 1. Patient age is between 18 and 75 years old. 2. Patient is clinically diagnosed with diabetes (T1D or T2D), with more than 50% on a stable insulin regimen, defined as no change in the prescribed number of basal insulin administrations per day and less than 10% change in basal total daily insulin dose within 3 months prior to enrollment. Patients not using insulin are considered having a stable treatment regimen if their diabetes management (lifestyle measures and/or non-insulin glucose-lowering medications) has remained unchanged within 3 months prior to enrollment and no treatment intensification is anticipated during the blinded phase. 3\. Patient has a HbA1c of \>7.5%. 4. Patient and investigator signed and dated the informed consent form prior to first sensor placement. Exclusion Criteria: * 1\. Use of any type of rtCGM within 3 months prior to study entry. 2. Severe hypoglycemia requiring assistance from another individual within the last 12 months, or seizure or loss of consciousness within the last 3 years. 3\. Severe hyperglycemia, that required hospitalization within the last 6 months. 4\. More than one diabetic ketoacidosis (DKA) event in the past year. 5. History of seizures other than due to hypoglycemia. 6. Myocardial infarction or stroke within the past 6 months. 7. Estimated glomerular filtration rate (eGFR) \< 30 mL/min obtained within the prior 12 months as part of usual care, or kidney transplant. 8\. Requirement to undergo magnetic resonance imaging (MRI) during the study period. 9\. Most recent thyroid function test results abnormal, obtained as part of usual care within the prior 2 years. 10\. Presence of a significant medical or psychiatric disorder, or use of a medication that, in the judgment of the investigator, will affect the wearing of sensors, completion of any aspect of the protocol, or increase risk. 11\. Cognitive difficulties that, in the judgment of the investigator, could impair the individual's ability to follow the protocol or increase risk. 12\. Inpatient psychiatric treatment within the past 6 months. 13. Currently pregnant, lactating, or planning to become pregnant during the study period (within the past 1 month). 14\. Deemed unsuitable by investigators due to any condition that impacts the reliability of HbA1c measurement. 15\. Patient is unable / unwilling to provide informed consent. 16. Patient is unable to comply with the protocol or proposed follow-up visits. 17. Patient who is currently enrolled in another clinical study, or has recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.