Nctid:
NCT06227650
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}], "ancestors"=>[{"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes", "relevance"=>"HIGH"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M13115", "name"=>"Pancreatitis", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000007328", "term"=>"Insulin"}], "ancestors"=>[{"id"=>"D000007004", "term"=>"Hypoglycemic Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M10365", "name"=>"Insulin", "asFound"=>"Day 1", "relevance"=>"HIGH"}, {"id"=>"M173166", "name"=>"Insulin, Globin Zinc", "relevance"=>"LOW"}, {"id"=>"M22554", "name"=>"Pancrelipase", "relevance"=>"LOW"}, {"id"=>"M13114", "name"=>"Pancreatin", "relevance"=>"LOW"}, {"id"=>"M10054", "name"=>"Hypoglycemic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>10}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-04-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-04-05", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-08", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percentage of time spent in the target", "timeFrame"=>"at day 0", "description"=>"Percentage of time spent in the target, between 70 and 180 mg/dl: 14 to 90 days before starting hybrid closed loop"}, {"measure"=>"Percentage of time spent in the target", "timeFrame"=>"at day 90", "description"=>"Percentage of time spent in the target, between 70 and 180 mg/dl the last 90 days available (T1) after starting hybrid closed loop"}], "secondaryOutcomes"=>[{"measure"=>"Percentage of time spent", "timeFrame"=>"at day 0", "description"=>"Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range )"}, {"measure"=>"Percentage of time spent", "timeFrame"=>"at day 90", "description"=>"Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range )"}, {"measure"=>"Pourcentage of closed-loop mode use", "timeFrame"=>"at day 90", "description"=>"Pourcentage of closed-loop mode use"}, {"measure"=>"Hypoglycemia events (serveral hypoglycemia )", "timeFrame"=>"at day 0", "description"=>"Number of serveral hypoglycemia events requiring hospitilisation and/or emergency"}, {"measure"=>"Hypoglycemia events (serveral hypoglycemia )", "timeFrame"=>"at day 90", "description"=>"Number of serveral hypoglycemia events requiring hospitilisation and/or emergency"}, {"measure"=>"Hyperglycemia events", "timeFrame"=>"at day 0", "description"=>"Number of hyperglycemia events requiring hospitalisation and /or emergency"}, {"measure"=>"Hyperglycemia events", "timeFrame"=>"at day 90", "description"=>"Number of hyperglycemia events requiring hospitalisation and /or emergency"}, {"measure"=>"Glucose Management Indicator (GMI)", "timeFrame"=>"at day 0", "description"=>"Glucose Management Indicator (GMI)"}, {"measure"=>"Glucose Management Indicator (GMI)", "timeFrame"=>"at day 90", "description"=>"Glucose Management Indicator (GMI)"}, {"measure"=>"Coeffecient of variabilty of Glucose Management Indicator", "timeFrame"=>"at day 0", "description"=>"Coeffecient of variabilty"}, {"measure"=>"Coeffecient of variabilty of Glucose Management Indicator", "timeFrame"=>"at day 90", "description"=>"Coeffecient of variabilty"}, {"measure"=>"Microangiopathic events", "timeFrame"=>"at day 0", "description"=>"Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )"}, {"measure"=>"Microangiopathic events", "timeFrame"=>"at day 90", "description"=>"Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Closed-loop insulin delivery systems", "artificial pancreas", "pancreatitis", "pancreatectomy", "secondary diabetes", "continuous glucose monitoring"], "conditions"=>["Secondary Pancreatic Diabetes"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems (\"artificial pancreas\").", "detailedDescription"=>"Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.\n\nA retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with secondary pancreatic diabetes and implementation of automated insulin therapy in BF", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult patient\n* Presenting secondary pancreatic diabetes\n* Treatment with insulin closed-loop delivery\n\nExclusion Criteria:\n\n* Patient who objected to the use of data"}, "identificationModule"=>{"nctId"=>"NCT06227650", "acronym"=>"IADIASP", "briefTitle"=>"Closed-loop Insulin Delivery Systems in Pancreatic Diabetes", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier Sud Francilien"}, "officialTitle"=>"Closed-loop Insulin Delivery Systems (\"Artificial Pancreas\") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series", "orgStudyIdInfo"=>{"id"=>"2023/0057"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Group1", "description"=>"Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device", "interventionNames"=>["Device: hybrid closed loop insulin delivery system"]}], "interventions"=>[{"name"=>"hybrid closed loop insulin delivery system", "type"=>"DEVICE", "description"=>"Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device", "armGroupLabels"=>["Group1"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"9110", "city"=>"Corbeil-Essonnes", "state"=>"Fra", "country"=>"France", "facility"=>"Centre Hospitalier Sud Francilien", "geoPoint"=>{"lat"=>48.60603, "lon"=>2.48757}}], "overallOfficials"=>[{"name"=>"Alfred PENFORNIS, PHD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Centre Hospitalier Sud Francilien"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Hospitalier Sud Francilien", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
