Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT04485351
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.', 'timeFrame': '6 months period prior to lockdown - 6 weeks period following the end of the lockdown', 'description': 'HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.'}], 'secondaryOutcomes': [{'measure': 'Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy', 'timeFrame': '6 weeks period following the end of the lockdown', 'description': 'Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records'}, {'measure': 'Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.', 'timeFrame': '6 months period prior to lockdown - 6 weeks period following the end of the lockdown', 'description': 'Use BMI, lipid profile, renal and hepatic function from medical records'}, {'measure': 'Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.', 'timeFrame': '6 weeks period following the end of the lockdown', 'description': 'Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization'}, {'measure': 'Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.', 'timeFrame': '6 weeks period following the end of the lockdown', 'description': 'Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation'}, {'measure': "Describe the proportion of patients who changed their lifestyle's habits during the lockdown.", 'timeFrame': '6 weeks period following the end of the lockdown', 'description': 'Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco'}, {'measure': 'Describe healthcare consumption of patients with diabetes during the lockdown.', 'timeFrame': '6 weeks period following the end of the lockdown', 'description': 'Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)'}, {'measure': 'Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.', 'timeFrame': '6 weeks period following the end of the lockdown', 'description': 'Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'lockdown', 'covid-19'], 'conditions': ['Diabetes Mellitus', 'Coronavirus Infection', 'Metabolic Disease', 'Glucose Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '34241812', 'type': 'DERIVED', 'citation': 'Ludwig L, Scheyer N, Remen T, Guerci B. The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study. Diabetes Ther. 2021 Aug;12(8):2207-2221. doi: 10.1007/s13300-021-01105-y. Epub 2021 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.\n\nThe French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.\n\nThis cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Patient with diabetes known for at least 6 months before inclusion\n* Patient followed by a specialist physician from the University Hospital of Nancy for routine care within the 6 months prior to the lockdown.\n* Patient who was assessed for prioritization of care following the end of the lockdown by the department of endocrinology, diabetology and nutrition\n\nExclusion Criteria:\n\n* Subjects opposed to the use of their data\n* Minors, adults under guardianship, protected persons'}, 'identificationModule': {'nctId': 'NCT04485351', 'acronym': 'CONFI-DIAB', 'briefTitle': 'Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study', 'orgStudyIdInfo': {'id': '2020PI137'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic patients from the University Hospital of Nancy', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Diabetic patients from the University Hospital of Nancy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lisa Ludwig, Dr', 'role': 'CONTACT'}], 'facility': 'University Regional Hospital of Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Lisa Ludwig, Dr', 'role': 'CONTACT', 'email': 'L.LUDWIG@chru-nancy.fr', 'phone': '+33383155056'}], 'overallOfficials': [{'name': 'Lisa Ludwig, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}