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

NCT07802327 | Not Yet Recruiting

• 1 other identifier: PROMISE-GX
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Diabetes Mellitus; Diabetes Mellitus ( Type 1 and Type 2)

Keywords

Continuous Glucose Monitoring; Time in Range; Diabetes Mellitus; Post-Market Clinical Follow-up

Outcome Measures

Primary Outcomes (2)

• Change in Time in Range (TIR), Time Above Range (TAR), and Time Below Range (TBR) from Blinded Baseline to Unblinded CGM Use

  15-day blinded run-in period compared to Day 45 unblinded follow-up visit

• 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.

  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)

  Baseline (Visit 1) to End of Study (Visit 5, Day 135)

Study Arms (1)

GX-01S Continuous Glucose Monitoring System

EXPERIMENTAL

All participants will use the GX-01S Continuous Glucose Monitoring (CGM) System. The study consists of a 15-day blinded run-in period during which participants wear the sensor but do not have access to real-time glucose data (baseline period), followed by a 120-day unblinded period during which participants have full access to real-time glucose data and all app functionalities. Sensors are worn continuously and replaced every 15 days. Total study duration is approximately 135 days (about 4.5 months) per participant.

Device: GX-01S Continuous Glucose Monitoring System

Interventions

GX-01S Continuous Glucose Monitoring System DEVICE

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.

GX-01S Continuous Glucose Monitoring System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of seizures other than due to hypoglycemia.
• Myocardial infarction or stroke within the past 6 month.
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min obtained within the prior 12 months as part of usual care, or kidney transplant.
• Requirement to undergo magnetic resonance imaging (MRI) during the study period.
• Most recent thyroid function test results abnormal, obtained as part of usual care within the prior 2 years.
• 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.
• Cognitive difficulties that, in the judgment of the investigator, could impair the individual's ability to follow the protocol or increase risk.
• Inpatient psychiatric treatment within the past 6 months.
• Currently pregnant, lactating, or planning to become pregnant during the study period (within the past 1 month).
• Deemed unsuitable by investigators due to any condition that impacts the reliability of HbA1c measurement.
• Patient is unable / unwilling to provide informed consent.

Sponsors & Collaborators

• MicroTech Medical（Hangzhou）Co.,Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Julia Mader, Professor, M.D.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maudline Abra Novihoho

CONTACT

+8613648604281; na.mao@microtechmd.com

Tim Enis

CONTACT

tim.enis@archerresearch.eu

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: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share