PMCF Study of GX-01S CGM in Adults With Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMicroTech Medical（Hangzhou）Co.,Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age is between 18 and 75 years old.
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.
Patient has a HbA1c of >7.5%.
Patient and investigator signed and dated the informed consent form prior to first sensor placement.
Disqualifiers
Use of any type of rtCGM within 3 months prior to study entry.
Severe hypoglycemia requiring assistance from another individual within the last 12 months, or seizure or loss of consciousness within the last 3 years.
Severe hyperglycemia, that required hospitalization within the last 6 months.
More than one diabetic ketoacidosis (DKA) event in the past year.
Trial design
Design model
Single group
Treatments tested in this trial
GX-01S Continuous Glucose Monitoring System
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: GX-01S Continuous Glucose Monitoring SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Time in Range (TIR), Time Above Range (TAR), and Time Below Range (TBR) from Blinded Baseline to Unblinded CGM Use
Time frame
15-day blinded run-in period compared to Day 45 unblinded follow-up visit2
Change in Time in Range (TIR), Time Above Range (TAR), and Time Below Range (TBR) from Blinded Baseline to Unblinded CGM Use
Change in CGM-derived glycemic metrics: Time in Range (TIR, 70-180 mg/dL), Time Above Range (TAR, \>180 mg/dL), and Time Below Range (TBR, \<70 mg/dL). Calculated using blinded CGM data from the 15-day run-in period compared to unblinded CGM data at the Day 45 follow-up visit.
Time frame
15-day blinded run-in period (Visit 2 to Visit 3) compared to Day 45 unblinded follow-up visit (Visit 3 to Visit 4)Secondary outcomes
1
Change in Hemoglobin A1c (HbA1c)
Change in HbA1c from baseline (Visit 1) to end of study (Visit 5, Day 135).
Time frame
Baseline (Visit 1) to End of Study (Visit 5, Day 135)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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