Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05144802
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2021-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess accuracy of interstitial glucose values measured respectively by FreeStyle® Libre and Dexcom® G6 compared to blood glucose values in standardized hypoxemia conditions in patients with diabetes and in healthy volunteers.', 'timeFrame': 'Day 1', 'description': 'Mean absolute relative difference (MARD)'}], 'secondaryOutcomes': [{'measure': 'Safety of acute hypoxia', 'timeFrame': 'Day 1', 'description': 'Arterial blood oxygen saturation (Sp02)'}, {'measure': 'Tolerability of acute hypoxia', 'timeFrame': 'Day 1', 'description': 'Lake Louise Questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CGM (Continuous Glucose Monitoring)'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia).\n\nOur purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: all population\n\n* No history of respiratory diseases (childhood asthma, respiratory allergies, exercise-induced asthma or dyspnea)\n* Willing to participate and able to sign an informed consent form (ICF)\n* Being affiliated with the French Social Security\n\nInclusion Criteria:Patients with diabetes\n\n* type 1 diabetes mellitus or type 2 diabetes mellitus (ADA definition)\n* Age : 18 to 75 years\n* stable diabetes treatment for more than 3 months\n* no diabetic retinopathy\n* no diabetic neuropathy\n* no cardiovascular diseases\n* no contra-indication for coronary computed tomography angiography or myocardial perfusion scintigraphy.\n\nInclusion Criteria: Healthy volunteers\n\n* Age : 18 ; 40 years\n* No diabetes\n* No persistant drug use \\> 3 months except contraception\n* Body mass index : \\[18,5 - 29,9\\] kg/m2\n\nNon-inclusion criteria : all population\n\n* Active smokers\n* Pregnant or breastfeeding women, women of childbearing age without effective contraception\n* Known allergies to the patch.\n* Skin lesions at the sensor site that may interfere with sensor placement or accuracy\n* Major cardiovascular complications within the past 3 months\n* Decompensated congestive heart failure\n* Chronic respiratory failure\n* Chronic renal failure\n* Resting ambient air O2 saturation ≤95%.\n* Treatment with systemic corticosteroids\n* Severe hypertension (≥180 mmHg systolic pressure or ≥ 100 mmHg diastolic pressure)\n* Any concomitant disease or condition that the investigator believes may compromise patient safety or affect the conduct of the study\n* Anemia (Hb\\<12g/dl)\n* History of severe mountain sickness\n* Concurrent participation in another clinical research study,\n* Persons benefiting from enhanced protection\n\nNon-inclusion criteria: Patients with diabetes\n\n* Absolute contraindications to physical activity (HAS definitin) :\n* Pulmonary arterial hypertension (\\> 60 mm Hg)\n* Presence of intra-cardiac thrombus\n* Acute pericardial effusion\n* Severe obstructive cardiomyopathy\n* Symptomatic aortic stenosis\n* Recent thrombophlebitis with or without pulmonary embolism'}, 'identificationModule': {'nctId': 'NCT05144802', 'briefTitle': 'Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions', 'orgStudyIdInfo': {'id': 'FOX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm', 'description': 'In this group, participants will be continuously monitored for their interstitial glucose level with 2 CGM devices : FreeStyle Libre 2 will be applied on right arm and Dexcom G6 will be applied on left arm.', 'interventionNames': ['Procedure: acute hypoxia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm', 'description': 'In this group, participants will be continuously monitored for their interstitial glucose level with 2 CGM devices : Dexcom G6 will be applied on right arm and FreeStyle Libre 2 will be applied on left arm.', 'interventionNames': ['Procedure: acute hypoxia']}], 'interventions': [{'name': 'acute hypoxia', 'type': 'PROCEDURE', 'description': 'Participants will be exposed to a 3-hour acute hypoxia', 'armGroupLabels': ['group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm', 'group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}