Can a 15-Day wearable sensor keep blood sugar on target?
NCT ID NCT07802327
First seen Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This trial tests whether the GX-01S continuous glucose monitoring system helps adults with type 1 or type 2 diabetes improve their blood sugar control. Participants wear the sensor for about 4.5 months, with the first 15 days blinded to establish a baseline, then full access to real-time glucose readings. Researchers measure changes in time in range, HbA1c, safety, and quality of life. The study enrolls 100 adults across multiple European centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GX-01S Continuous Glucose Monitoring System, a wearable device that measures glucose levels in real time
- What this could lead to
- If it works, this device could help people with diabetes keep their blood sugar in a healthier range more easily, reducing the risk of complications.
- What could go wrong
- This is a post-market study, so the device is already available. The trial is relatively small and focuses on short-term glucose control, so long-term benefits remain uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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