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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Diabetes Mellitus ( Type 1 and Type 2)
• Intervention / Treatment: Device: GX-01S Continuous Glucose Monitoring System

Detailed Description

Diabetes mellitus remains one of the most prevalent chronic diseases worldwide, contributing significantly to morbidity, mortality, and healthcare costs. For individuals with Type 1 Diabetes (T1D) and many with Type 2 Diabetes (T2D), insulin therapy is essential for maintaining glycemic control and preventing acute and long-term complications. Traditional self-monitoring of blood glucose (SMBG) via fingertip testing, while effective, has limitations including pain, inconvenience, and the inability to capture glucose trends or nocturnal fluctuations.

Continuous Glucose Monitoring Systems (CGMS) have emerged as a transformative technology in diabetes management. By measuring interstitial glucose levels at frequent intervals, CGMS offers real-time glucose data, trend information, and alerts for hypo- and hyperglycemic events. These features support more informed treatment decisions, reduce the burden of fingertip testing, and have been shown to improve glycemic outcomes such as Time In Range (TIR) and Hemoglobin A1c (HbA1c).

Despite the growing adoption of CGMS, real-world evidence on patient acceptance, clinical benefits, and the impact of device-specific features-such as remote data sharing and retrospective pattern analysis-remains limited, particularly in European populations. Furthermore, understanding the reasons for device discontinuation, including skin reactions, sensor insertion burden, and body image concerns, is critical for optimizing patient-centered care.

The GX-01S Continuous Glucose Monitoring System is a single-use, real-time medical device designed to provide continuous 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.

This PROspective Post-Market Clinical Follow-Up (PMCF) study aims to evaluate the clinical benefits of the GX-01S CGM System in adult patients with diabetes. The investigation will focus on improvements in glycemic control, treatment satisfaction, device usability, quality of life, and safety outcomes in a real-world European cohort. Findings from this study are intended to support the clinical utility and patient acceptance of CGMS as a standard of care in diabetes management.

The primary objective of this study is to demonstrate that use of the GX-01S CGM System can improve glycemic control, as measured by an improvement in CGM-derived glycemic metrics (TIR, Time Above Range [TAR], and Time Below Range [TBR]) after 30 days of device usage, compared to baseline. Baseline is defined as the blinded 15-day CGM run-in period during which participants use the GX-01S CGM without access to real-time glucose data.

The secondary objectives are to assess efficacy, ease of use, and safety of the GX-01S CGM System, as well as patient treatment satisfaction and quality of life. Secondary outcomes include change in HbA1c, treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ), satisfaction and quality of life measured by the CGM Satisfaction Scale (CGM-SAT), device usability measured by the Post-Study System Usability Questionnaire (PSSUQ), and the number and type of (serious) adverse events and device deficiencies.

The study is a post-market, commercial, prospective, interventional, single-arm multicenter study. A total of 100 adult patients with T1D and T2D will be enrolled, with at least 70% being T1D patients and more than 50% on a stable insulin regimen. Enrollment will take place across multiple centers in Europe. Participants will be followed for approximately 135 days (about 4.5 months), consisting of a 15-day blinded run-in period and a 120-day unblinded period with full access to real-time glucose data.

The sensor insertion is a minimally invasive procedure performed by the participant under the supervision of qualified site staff. Sensors will be applied to the back of the upper arm and replaced every 15 days. Participants will use a study-specific blinded application during the run-in period and the commercial LinX application during the unblinded period. Investigators will have remote access to sensor data through the Pancares Web Portal for monitoring and data collection.

The study has received ethical approval from the relevant Ethics Committees and will be conducted in compliance with ISO 14155, the Declaration of Helsinki, and the EU Medical Device Regulation (MDR) 2017/745. Results will be published to support the clinical utility of the GX-01S CGM System in diabetes management.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maudline Abra Novihoho; Phone Number: +8613648604281; Email: na.mao@microtechmd.com
• Study Contact Backup: Name: Tim Enis; Email: tim.enis@archerresearch.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Patient is unable to comply with the protocol or proposed follow-up visits.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GX-01S Continuous Glucose Monitoring System; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c (HbA1c)	Change in HbA1c from baseline (Visit 1) to end of study (Visit 5, Day 135).	Baseline (Visit 1) to End of Study (Visit 5, Day 135)

Collaborators and Investigators

• Sponsor: MicroTech Medical（Hangzhou）Co.,Ltd.
• Investigators: Principal Investigator: Julia Mader, Professor, M.D., Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 5, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Diabetes Mellitus; Time in Range; Post-Market Clinical Follow-up
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: PROMISE-GX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No