Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT03682250
Status:
TERMINATED
Last Update Posted:
2025-02-25
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes 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': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No one with the qualifications required to analyse the data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QT intervals corrected for heart rate', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Percentage of time between 4.0 and 10.0 mmol/L', 'timeFrame': '48 hours'}, {'measure': 'Percentage of time below 3.5 mmol/L', 'timeFrame': '48 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The population of type 1 diabetes patients with cardiovascular disease is increasing and this study aims to explore the electrocardiographic changes that are associated with spontaneous hypoglycemia in this type of population. More precisely, this study will investigate if these modifications are of the same nature as those already observed in different populations (patients with type 2 diabetes) to see the pro-arrhythmogenic impact of hypoglycemia in patients with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with type 1 diabetes presenting a high cardiovascular risk', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years old;\n* Be able to give informed consent;\n* Diagnosis of type 1 diabetes for ≥ 6 months;\n* Treated with intensive insulin therapy (multiple injections of insulin or insulin pump)\n\nAND EITHER\n\n* A history of CV disease defined as: 1) Established diagnosis of atherosclerotic coronary artery disease (example: previous history of infarction); 2) Previous cerebral Vascular Stroke or Transient Ischemic Accident; 3) Anterior revascularization of the coronary arteries, carotid artery or peripheral arteries; 4) At least one coronary stenosis, carotid artery or lower extremity arteries \\> 50%; 5) History of symptomatic coronary heart disease confirmed with hospitalization or a positive stress test result or by any cardiac imaging result, or unstable angina with changes observed at the ECG; 6) Asymptomatic cardiac ischemia confirmed by a nuclear imaging test, an exercise test, a dobutamine stress echo; 7) NYHA II-III class chronic heart failure; 8) Amputation of limb or foot due to circulatory insufficiency.\n* Or more than 20 years duration of T1D and at least 2 of the following risk factors or associated condition: 1) Chronic renal failure eGFR \\<60 ml / min / 1.73 m2); 2) Presence of micro or macro-albuminuria (albumin / creatinine ratio \\> 2); 3) Hypertension or treatment for hypertension; 4) Hyperlipidemia or treatment for hypolipemia; 5) Abdominal obesity (Waist circumference\\> 94 cm for men and \\> 80 cm for women); 6) Smoking ; 7) Significant retinopathy (pre-proliferative, proliferating, laser or intravitreous injection); 8) Body mass index \\> 30 kg /m2; 9) Erectile dysfunction; 10) Left ventricular hypertrophy; 11) Positive family history of early MCAS (H \\< 55 years old and F \\< 65 years old)\n\nExclusion Criteria:\n\n* Definitive criteria: 1) QRS \\> 120 ms on the baseline ECG; 2) Presence of atrial fibrillation at inclusion; 3) Current intake of any drug that may prolong QT according to the judgment of the investigator and the update of the list available on www.professionsante.com.\n* Transient criteria (the patient can be included once the anomaly is corrected): 1) Hypokalemia (\\< 3.5 mmol/L); 2) Hypocalcemia (ionized calcium \\< 1.10 mmol/L); 3) Hypomagnesemia (\\< 0.7 mmol/L)'}, 'identificationModule': {'nctId': 'NCT03682250', 'briefTitle': 'Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recherches Cliniques de Montreal'}, 'officialTitle': 'Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients with Type 1 Diabetes At High Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'FRYPOT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with type 1 diabetes with a high cardiovascular risk', 'interventionNames': ['Device: FreeStyle Libre Pro', 'Device: Holter monitor']}], 'interventions': [{'name': 'FreeStyle Libre Pro', 'type': 'DEVICE', 'description': 'A FreeStyle Libre Pro will be used to identify hypoglycemic episodes', 'armGroupLabels': ['Patients with type 1 diabetes with a high cardiovascular risk']}, {'name': 'Holter monitor', 'type': 'DEVICE', 'description': "A Holter monitor will be used to measure heart's activity", 'armGroupLabels': ['Patients with type 1 diabetes with a high cardiovascular risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de recherches cliniques de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Remi Rabasa-Lhoret', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de recherches cliniques de Montréal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Cliniques de Montreal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Rémi Rabasa-Lhoret', 'investigatorAffiliation': 'Institut de Recherches Cliniques de Montreal'}}}}