Diabetes MellitusNCT07448805
Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
A study testing continuous glucose monitor in people with Diabetes Mellitus and Blood Sugar, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
Researchers at the Department of Intensive Internal Medicine and the Department of Endocrinology and Diabetology will conduct a study to verify the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients in intensive internal care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Blood Sugar, Sepsis
- What is being tested?
- continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 18 Feb 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the intensive care unit
- Expected ICU stay more than 24 hours
- Presence of an arterial line
Who cannot join
- Age under 18
- Pregnancy
- Skin changes that prevent sensor application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Researchers at the Department of Intensive Internal Medicine and the Department of Endocrinology and Diabetology will conduct a study to verify the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients in intensive internal care. Almost 150,000 people in Slovenia have diabetes, so keeping a close eye on blood sugar levels is key to preventing complications. The new sensors for continuous monitoring are available over the counter and certified as medical devices. The study will include at least 100 patients who will need blood sugar monitoring during their stay in the intensive care unit. Each patient will have two small sensors placed on each upper arm to continuously measure their blood sugar levels, but these values will not be visible to medical staff. At the same time, healthcare professionals will perform routine blood sugar measurements, and researchers will then compare the accuracy of both methods. The procedure is safe and painless, and patients will receive the same quality of care as usual.
- Being tested
- continuous glucose monitor
- Keywords
- diabetes mellitus, continuous glucose monitor, blood sugar, intensive care unit, sepsis, critically ill intensive care unit patients
- Medical subject headings
- Diabetes Mellitus, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitorDevice
patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| CGM | Experimental | patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring Receives: Device: continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of sensor functional uptime during the ICU stay.
The proportion of time during which the CGM system continuously provided glucose data without signal loss or mechanical sensor failure.
Measured: From enrollment to discharge or up to 14 days.
Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements.
Statistical comparison between CGM values and reference laboratory measurements from arterial blood to assess the accuracy of the device.
Measured: From admission to discharge or up to 14 days.
Secondary outcomes (3)
Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements.
The MARD will be calculated to assess CGM accuracy compared to the gold standard (arterial blood gas). To evaluate the impact of noradrenaline, MARD will be stratified and compared between two patient groups: those receiving noradrenaline (Yes) and those not receiving noradrenaline (No). Unit of Measure: Percentage (%).
Measured: From enrollment to discharge or up to 14 days.
CGM lifespan in ICU conditions.
The effective duration of CGM sensor function will be evaluated and compared to the manufacturer's expected lifespan.
Measured: From enrollment to discharge or up to 14 days.
CGM glucose measurements are comparable to arterial blood glucose measurements.
We will measure glucose in interstitial fluid with a CGM, expressed in mmol/l, and obtain arterial blood to determine blood glucose in mmol/l, and compare the analyses.
Measured: From enrollment to discharge or up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start18 Feb 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CGM glucose monitoring is feasible in the intensive care unit. Blood glucose measurements from arterial blood are comparable to those from the CGM sensor.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nika Kravos Tramšek, MD PhD, Principal investigator, UMC Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448805
- Sponsor's protocol ID
- OIIM CGM
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
- ClinicalTrials.gov ID
- NCT07448805
- Acronym / sponsor ID
- OIIM CGM
- Keywords
- diabetes mellitus, continuous glucose monitor, blood sugar, intensive care unit, sepsis, critically ill intensive care unit patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers at the Department of Intensive Internal Medicine and the Department of Endocrinology and Diabetology will conduct a study to verify the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients in intensive internal care. Almost 150,000 people in Slovenia have diabetes, so keeping a close eye on blood sugar levels is key to preventing complications. The new sensors for continuous monitoring are available over the counter and certified as medical devices. The study will include at least 100 patients who will need blood sugar monitoring during their stay in the intensive care unit. Each patient will have two small sensors placed on each upper arm to continuously measure their blood sugar levels, but these values will not be visible to medical staff. At the same time, healthcare professionals will perform routine blood sugar measurements, and researchers will then compare the accuracy of both methods. The procedure is safe and painless, and patients will receive the same quality of care as usual.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CGM glucose monitoring is feasible in the intensive care unit. Blood glucose measurements from arterial blood are comparable to those from the CGM sensor.
| Arm | Type | Receives |
|---|---|---|
| CGM | Experimental | Device: continuous glucose monitorpatients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to the intensive care unit
- Expected ICU stay more than 24 hours
- Presence of an arterial line
Key exclusion criteria (3 listed)
- Age under 18
- Pregnancy
- Skin changes that prevent sensor application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous glucose monitorpatients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring | Device | CGM |
Primary outcome
Percentage of sensor functional uptime during the ICU stay.
Time frame: From enrollment to discharge or up to 14 days.
The proportion of time during which the CGM system continuously provided glucose data without signal loss or mechanical sensor failure.
Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements.
Time frame: From admission to discharge or up to 14 days.
Statistical comparison between CGM values and reference laboratory measurements from arterial blood to assess the accuracy of the device.
3 secondary outcomes
Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements.
Time frame: From enrollment to discharge or up to 14 days.
CGM lifespan in ICU conditions.
Time frame: From enrollment to discharge or up to 14 days.
CGM glucose measurements are comparable to arterial blood glucose measurements.
Time frame: From enrollment to discharge or up to 14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nika Kravos Tramšek, MD PhD principal investigator
UMC Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous glucose monitor in people with Diabetes Mellitus and Blood Sugar, run by University Medical Centre Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nika Kravos Tramšek, MD PhD (+38631423030, nikakravos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of sensor functional uptime during the ICU stay. (time frame: From enrollment to discharge or up to 14 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.