Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 3:36 AM
Study NCT ID:
NCT05662657
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2022-12-14', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the prevalence of post-traumatic stress disorder (PTSD) in adult with Type 1 Diabetes', 'timeFrame': 'baseline', 'description': 'Score (\\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia'}], 'secondaryOutcomes': [{'measure': 'To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to diabetes diagnosis and its initial management.', 'timeFrame': 'baseline', 'description': 'Score (\\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S).\n\nThe patient will complete the questionnaire once to evaluate PTSD related to both diabete diagnosis and its initial management.'}, {'measure': 'To evaluate the prevalence of post-traumatic stress disorder (PTSD) related to severe hypoglycemia.', 'timeFrame': 'baseline', 'description': 'Score (\\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S) for severe hypoglycemia'}, {'measure': 'To evaluate the prevalence of post-traumatic stress disorder (PTSD). This PTSD is related to at least one of the following reasons : - severe hypoglycemia - diabetes diagnosis and its initial management.', 'timeFrame': 'baseline', 'description': 'Score (\\>44) measured on the Posttraumatic Stress Disorder Checklist Scale (PCL-S).\n\nThe patient will complete the questionnaire once to evaluate PTSD related to severe hypoglycemia and/or diabetes diagnosis and its initial management'}, {'measure': 'To evaluate the prevalence of anxiety-depressive disorder in adults with type 1 diabetes', 'timeFrame': 'baseline', 'description': 'Score (from 0 to 42 ) measured on the Hospital Anxiety and Depression Scale (HADS)\n\nTotal scores can be categorized into five levels:\n\n* HADS score of 7 or less = no symptoms,\n* HADS score of 8 to 10 = doubtful symptomatology,\n* HADS score of 11 or more = definite symptomatology.'}, {'measure': 'To demonstrate the presence of anxiety-depressive disorder related to PTSD', 'timeFrame': 'baseline', 'description': 'Rate of patients with anxiety depressive disorder associated with PTSD'}, {'measure': 'To evaluate whether there is a correlation between PTSD and the patient participation to a therapeutic education program', 'timeFrame': 'baseline', 'description': 'Percentage of patients with PTSD (PCL-S \\> 44) between groups of patients participating or not in a therapeutic education program (Functional Insulin Therapy or multidisciplinary education in day hospital or hospitalization)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'In France, the adult population living with diabetes in 2016 is estimated at more than 3.3 million patients treated. Type 1 diabetes (T1DM) represents 5.6% of diabetic patients (approximately 185,000 patients).\n\nNumerous studies show that patients fear hypoglycemia, with an impact on their quality of life, sleep disorders and depressive symptoms. In addition, there is a metabolic impact with a problem of therapeutic compliance and an alteration of glycemic control.\n\nThis study examine the relation between Post Traumatic Stress disorder (PTSD) and diabetes diagnosis or severe hypoglycaemia in adults with Type 1 Diabetes.\n\nThe aim of this study is to evaluate the prevalence of PTSD in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'population of insulin-treated type 1 diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older,\n* With type 1 diabetes,\n* Willing and able to complete all the questionnaires in French,\n* Who have given oral consent,\n* being affiliated to a social security scheme or being a beneficiary of such a scheme.\n\nExclusion Criteria:\n\n* Non-diabetic type 1,\n* With an unstable psychiatric pathology,\n* Pregnant or breastfeeding women,\n* Subject to a measure for the protection of justice,\n* Having opposed the research.'}, 'identificationModule': {'nctId': 'NCT05662657', 'briefTitle': 'Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital St. Joseph, Marseille, France'}, 'officialTitle': 'Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'DIASPOT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diagnostic Test: PCL-S Questionnaire', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diagnostic Test: HADS Questionnaire'], 'description': 'PCL-S and HADS questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13008', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rahamia AHAMADA', 'role': 'CONTACT'}, {'name': 'Lise DUFAITRE PATOURAUX, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13500', 'city': 'Martigues', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisa SARDE, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Martigues', 'geoPoint': {'lat': 43.40735, 'lon': 5.05526}}], 'centralContacts': [{'name': 'Rahamia AHAMADA', 'role': 'CONTACT', 'email': 'rahamada@hopital-saint-joseph.fr', 'phone': '0488731071'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital St. Joseph, Marseille, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}