Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT02790060
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fear of Hypoglycemia and Glycemic Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* blood (whole blood + plasma + serum)\n* urines'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-05-30', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear of hypoglycemia score', 'timeFrame': '2 weeks', 'description': 'hypoglycemia questionnaire and hypoglycemia reported by patients'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': 'from 2 weeks up to 3 months', 'description': 'SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit'}, {'measure': 'Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)', 'timeFrame': '2 weeks', 'description': 'reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '31182337', 'type': 'DERIVED', 'citation': 'Saulnier PJ, Briet C, Gand E, Chaillous L, Dubois S, Bonnet F, Leguerrier AM, Fradet G, Delcourt Crespin I, Kerlan V, Gouet D, Perlemoine C, Ducluzeau PH, Pichelin M, Wargny M, Gonder-Frederick L, Ragot S, Hadjadj S, Cariou B; VARDIA study group. No association between fear of hypoglycemia and blood glucose variability in type 1 diabetes: The cross-sectional VARDIA study. J Diabetes Complications. 2019 Aug;33(8):554-560. doi: 10.1016/j.jdiacomp.2019.05.003. Epub 2019 May 10.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of 5 questionnaires including fear of hypoglycemia-2 questionnaire.', 'detailedDescription': 'Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of questionnaires including fear of hypoglycemia-2 questionnaire.\n\nBiobanking of urine/blood Collection of key medical informations by investigators\n\nQuestionnaires :\n\n* socio-economic status\n* Fear of hypoglycemia-2\n* Anxiety Depression scale (HAD)\n* Health survey (SF36, SF12)\n* Satisfaction to treatment (DHP-18)\n* Dutch Eating Behavior Questionnaire (DEBQ)\n* Pittsburgh quality of sleep (PSQI)\n* Blood Glucose diary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* type 1 diabetes\n* at least 2 Blood Glucose monitoring daily\n* on insulin for more than 5 years\n\nExclusion Criteria :\n\n* not stable metabolic condition (infection, steroid therapy)\n* below 3 months change in insulin treatment\n* other clinical trial\n* renal failure (eDFG below 30 ml/min/1.73 m²)\n* Pregnancy and/or lactation'}, 'identificationModule': {'nctId': 'NCT02790060', 'acronym': 'VARDIA', 'briefTitle': 'Fear of Hypoglycemia and Glycemic Variability', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': "Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1", 'orgStudyIdInfo': {'id': 'VARDIA'}}, 'contactsLocationsModule': {'locations': [{'zip': '37170', 'city': 'Tours', 'state': 'France', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Brest University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'La Roche sur Yon Hospital', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'La Rochelle Hospital', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Lorient', 'country': 'France', 'facility': 'CH Bretagne sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '44035', 'city': 'Nantes', 'country': 'France', 'facility': 'Chu de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Chu de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}