Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:31 AM
Study NCT ID:
NCT07448805
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'CGM glucose monitoring is feasible in the intensive care unit. Blood glucose measurements from arterial blood are comparable to those from the CGM sensor.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensor reliability and failure rate.', 'timeFrame': 'From enrollment to discharge or up to 14 days.', 'description': 'The frequency of CGM sensor failures (signal loss, detachment or need for replacement) will be recorded and analysed.'}, {'measure': 'Causes of sensor malfunction.', 'timeFrame': 'From enrollment to discharge or up to 14 days.', 'description': 'Reasons for CGM sensor replacement (e.g. poor adhesion, calibration failure, mechanical damage, interference from clinical procedures) will be descriptively documented. We will count the number of sensor malfunction events.'}], 'primaryOutcomes': [{'measure': 'Percentage of sensor functional uptime during the ICU stay.', 'timeFrame': 'From enrollment to discharge or up to 14 days.', 'description': 'The proportion of time during which the CGM system continuously provided glucose data without signal loss or mechanical sensor failure.'}, {'measure': 'Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements.', 'timeFrame': 'From admission to discharge or up to 14 days.', 'description': 'Statistical comparison between CGM values and reference laboratory measurements from arterial blood to assess the accuracy of the device.'}], 'secondaryOutcomes': [{'measure': 'Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements.', 'timeFrame': 'From enrollment to discharge or up to 14 days.', 'description': '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 (%).'}, {'measure': 'CGM lifespan in ICU conditions.', 'timeFrame': 'From enrollment to discharge or up to 14 days.', 'description': "The effective duration of CGM sensor function will be evaluated and compared to the manufacturer's expected lifespan."}, {'measure': 'CGM glucose measurements are comparable to arterial blood glucose measurements.', 'timeFrame': 'From enrollment to discharge or up to 14 days.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'continuous glucose monitor', 'blood sugar', 'intensive care unit', 'sepsis', 'critically ill intensive care unit patients'], 'conditions': ['Diabetes Mellitus', 'Blood Sugar', 'Sepsis', 'Critically Ill Intensive Care Unit Patients']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to the intensive care unit\n* Expected ICU stay more than 24 hours\n* Presence of an arterial line\n\nExclusion Criteria:\n\n* Age under 18\n* Pregnancy\n* Skin changes that prevent sensor application'}, 'identificationModule': {'nctId': 'NCT07448805', 'briefTitle': 'Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Maribor'}, 'officialTitle': 'Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit', 'orgStudyIdInfo': {'id': 'OIIM CGM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGM', 'description': 'patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring', 'interventionNames': ['Device: continuous glucose monitor']}], 'interventions': [{'name': 'continuous glucose monitor', 'type': 'DEVICE', 'description': 'patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring', 'armGroupLabels': ['CGM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Maribor', 'status': 'RECRUITING', 'country': 'Slovenia', 'facility': 'UMC Maribor', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'centralContacts': [{'name': 'Nika Kravos Tramšek, MD PhD', 'role': 'CONTACT', 'email': 'nikakravos@gmail.com', 'phone': '+38631423030'}], 'overallOfficials': [{'name': 'Nika Kravos Tramšek, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Maribor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Maribor', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}