Nctid:
NCT06616779
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type 2 Diabetes", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes", "relevance"=>"HIGH"}, {"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"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10365", "name"=>"Insulin", "relevance"=>"LOW"}, {"id"=>"M173166", "name"=>"Insulin, Globin Zinc", "relevance"=>"LOW"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-03-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Efficacy - mean percentage of Fasting Blood Glucose", "timeFrame"=>"≥ 24 hours after start of the therapy by using the GlucoTab system", "description"=>"Efficacy is assessed by evaluating the mean percentage of Fasting Blood Glucose (FBG) in the FBG target range 80 - 180 mg/dl"}], "secondaryOutcomes"=>[{"measure"=>"Safety - number of hypoglycaemic events", "timeFrame"=>"at the end of the study, on average three months", "description"=>"Safety is assessed by evaluating the number of hypoglycaemic events"}, {"measure"=>"Efficacy", "timeFrame"=>"at the end of the study, on average three months", "description"=>"mean pre-breakfast blood glucose"}, {"measure"=>"Usability", "timeFrame"=>"at the end of the study, on average three months", "description"=>"Percentage of insulin dose injections performed according to the GlucoTab system"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Type 2 Diabetes", "Type 2 Diabetes Mellitus (T2DM)", "Type 2 Diabetes, Insulin Requiring"]}, "descriptionModule"=>{"briefSummary"=>"GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.\n\nIt provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.", "detailedDescription"=>"GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.\n\nIn this study, only the GlucoTab algorithm supported basal therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care requiring insulin therapy.\n\nGlucoTab has a CE certificate, will be used according to its intended purpose and no additional burdensome or invasive interventions are planned"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Non-critically ill patients with type 2 diabetes receiving domiciliary nursing care who require s.c. insulin therapy", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Informed consent obtained after being advised of the nature of the study\n* Male or female aged ≥ 18 years\n* Type 2 diabetes (treated with insulin therapy)\n* Receiving domiciliary nursing care\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus\n* intravenous insulin therapy\n* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy\n* continuous subcutaneous insulin infusion\n* gestational diabetes or pregnancy\n* known or suspected allergy to insulin\n* total parenteral nutrition\n* any mental condition rendering the patient incapable of giving his/her consent\n* any disease or condition which according to the investigator would interfere with the trial or the safety of the patient"}, "identificationModule"=>{"nctId"=>"NCT06616779", "briefTitle"=>"DigiDiab Evaluation Domiciliary Nursing Care", "organization"=>{"class"=>"OTHER", "fullName"=>"Medical University of Graz"}, "officialTitle"=>"An Open, Single-centre, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures", "orgStudyIdInfo"=>{"id"=>"DigiDiab Styria"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"GlucoTab Group", "interventionNames"=>["Device: GlucoTab"]}, {"label"=>"Retrospective Control Group", "interventionNames"=>["Other: Diabetes Treatment"]}], "interventions"=>[{"name"=>"GlucoTab", "type"=>"DEVICE", "description"=>"Insulin therapy will be started and adjusted according to the GlucoTab system with incorporated software algorithm. The goal of the basal insulin algorithm is to maintain blood glucose (BG) within acceptable targets according to the predefined health status. For a limited time period after therapy start, three BG measurements per day are suggested by the algorithm to determine blood glucose. Insulin dosage titration will be performed according to the algorithm in GlucoTab under supervision of the nurses of domiciliary nursing care. Correctional bolus insulin will be administered at defined time-points according to BG targets in the predefined health status. Nurses and nursing assistants will be trained in the use of the GlucoTab system.", "armGroupLabels"=>["GlucoTab Group"]}, {"name"=>"Diabetes Treatment", "type"=>"OTHER", "description"=>"Diabetes Standard Care", "armGroupLabels"=>["Retrospective Control Group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Lichtenegger", "role"=>"CONTACT", "email"=>"katharina.lichtenegger@medunigraz.at", "phone"=>"+4331638572766"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical University of Graz", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
