Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT07241702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse Wave Velocity', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess pulse wave velocity as a marker of arterial stiffness at baseline, at six and twelve months post-treatment'}, {'measure': 'Perfused Boundary Region', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess perfused boundary region as a marker of endothelial glycocalyx integrity at baseline, at six and twelve months post-treatment'}, {'measure': 'Global Longitudinal Strain', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess global londitudinal strain as a marker of myocardial function at baseline, at six and twelve months post-treatment'}], 'secondaryOutcomes': [{'measure': 'Central Systolic Blood Pressure', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess central systolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment'}, {'measure': 'Central Diastolic Blood Pressure', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess central diastolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment'}, {'measure': 'Augmentation Index', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess Augmentation Index as a marker of vascular function at baseline, at six and twelve months post-treatment'}, {'measure': 'Flow mediated dilation', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess Flow Mediated Dilation as a marker of endothelial function at baseline, at six and twelve months post-treatment'}, {'measure': 'Coronary flow reserve', 'timeFrame': 'Baseline, Six Months, Twelve months', 'description': 'The investigators will assess Coronary flow reserve at baseline, at six and twelve months post-treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized, observational cohort study conducted in adult patients with type 1 diabetes.Participants with poorly controlled T1D under multiple daily injection (MDI) treatment will be assigned to one of three treatment groups:\n\n1. hybrid closed-loop systems (HCLS) or\n2. Sodium glucose co-transporter 2 inhibitors (SGLT-2i) added to MDI or\n3. intensification of MDI treatment. Markers of endothelial and cardiovascular function will be assessed at baseline, at 6 and 12 months post-treatment. The primary objactive of the study is to evaluate the effect of HCLS on cardiovacular and endothelial function compared to MDI or SGLT-2i in T1D.', 'detailedDescription': 'Patients with type 1 diabetes mellitus (T1DM) present subclinical signs of vascular and endothelial dysfunction earlier compared to healthy individuals. Hybrid closed loop systems (HCLS) are currently the gold standard method for glycemic management, however, the data regarding its superiority in terms of the prevention of subclinical vascular and endothelial dysfunction are scarce. The aim of this study is to determine whether treatment with HCLS improves vascular and endothelial function compared to multiple daily injections (MDI) or Sodium glucose co-transporter 2 inhibitors (SGLT-2i) in patients with T1DM. Partcipants with poorly controlled T1DM under MDI treatment, will be assigned to receive either:\n\n1. HCLS or\n2. SGLT-2i as an add-on treatment to MDI or\n3. intensification of MDI treatment.\n\nWe will assess at baseline and 6 and 12 months post-treatment:\n\n(i) glycemic parameters derived via continuous glucose monitoring (GGM) (ii) pulse wave velocity (PWV) (iii)central systolic and diastolic blood pressure (cSBP, cDBP) (iv) the perfused boundary region (PBR) of the sublingual arterial microvessels, as a marker of endothelial glycocalyx integrity.\n\n(v) global longitudinal strain(GLS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with poorly controlled type 1 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* history of type 1 diabetes with diabetes duration \\> 5 years\n* HbA1c ≥ 7% and ≤ 10%\n* eGFR\\> 60ml/min/1,73m2.\n\nExclusion Criteria:\n\n* history of malignancy within the last 5 years\n* severe hepatic impairment\n* cardiovascular events within the recent three months'}, 'identificationModule': {'nctId': 'NCT07241702', 'briefTitle': 'EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'The Effect of Hybrid Closed-loop Systems on Markers of Endothelial, Myocardial and Vascular Function in Patients With Type 1 Diabetes.', 'orgStudyIdInfo': {'id': 'TYPE 1-HCLS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCL group', 'description': 'Patients will recieve hybrid closed loop system', 'interventionNames': ['Device: HCLS']}, {'label': 'SGLT-2i group', 'description': 'Patients will recieve SGLT-2i as add on treatment to multiple daily injections', 'interventionNames': ['Drug: SGLT2 inhibitor']}, {'label': 'MDI group', 'description': 'Patients will recieve intensification of MDI treatment.', 'interventionNames': ['Drug: MDI']}], 'interventions': [{'name': 'HCLS', 'type': 'DEVICE', 'description': 'Hybrid Closed-Loop System treatment', 'armGroupLabels': ['HCL group']}, {'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'description': 'SGLT-2 Inhibitor Treatment', 'armGroupLabels': ['SGLT-2i group']}, {'name': 'MDI', 'type': 'DRUG', 'description': 'Multiple Daily Injection Insulin treatment', 'armGroupLabels': ['MDI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'country': 'Greece', 'facility': 'Attikon University General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine-Endocrinology', 'investigatorFullName': 'VAIA LAMBADIARI', 'investigatorAffiliation': 'Attikon Hospital'}}}}