Managing of Missed Meal Bolus by HCL Systems

Launched by ZDENĚK ŠUMNÍK · Jan 19, 2024

Nctid: NCT06230276

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003922", "term"=>"Diabetes Mellitus, Type 1"}], "ancestors"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M7117", "name"=>"Diabetes Mellitus, Type 1", "asFound"=>"Diabetes Mellitus, Type 1", "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"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune 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"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2023-12-17", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.", "timeFrame"=>"4 hour after a meal"}], "secondaryOutcomes"=>[{"measure"=>"Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.", "timeFrame"=>"4 hours after a meal"}, {"measure"=>"Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.", "timeFrame"=>"4 hours after a meal"}, {"measure"=>"Difference in CGM parameters 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.", "timeFrame"=>"4 hours after a meal", "description"=>"time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\\> 13.9 mmol/L; \\>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\\< 3.0 mmol/L; \\<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL)"}, {"measure"=>"Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using different types of insulin analogs", "timeFrame"=>"4 hours after a meal", "description"=>"insulin analogs - aspart and ultra-rapid lispro"}, {"measure"=>"Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs", "timeFrame"=>"4 hours after a meal", "description"=>"insulin analogs - aspart and ultra-rapid lispro"}, {"measure"=>"Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs", "timeFrame"=>"4 hours after a meal", "description"=>"insulin analogs - aspart and ultra-rapid lispro"}, {"measure"=>"Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin ultra-rapid lispro", "timeFrame"=>"4 hours after a meal", "description"=>"time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\\> 13.9 mmol/L; \\>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\\< 3.0 mmol/L; \\<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL)"}, {"measure"=>"Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin aspart.", "timeFrame"=>"4 hours after a meal", "description"=>"time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\\> 13.9 mmol/L; \\>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\\< 3.0 mmol/L; \\<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL)"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Diabetes Mellitus, Type 1"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this interventional study is to compare glycemic outcomes after missed meal bolus in children and adolescents with type 1 diabetes (CwD) treated by one of the three most common used types of hybrid closed loop (HCL) systems - Medtronic MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS. The main questions it aims to answer are:\n\n* Do the glycemic outcomes (area under the curve of glucose concentration change, maximal glucose rise from baseline, time to maximal glucose rise from baseline, CGM parameters) vary after missed meal bolus among different types of HCL systems?\n* Does the type of insulin analog influence glycemic outcomes after a missed meal bolus?\n\nParticipants will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"19 years", "minimumAge"=>"9 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* children with type 1 diabetes (CwD) 9.00-18.99 years old\n* use of continuous glucose monitoring (CGM) \\>70% of the time 14 days before a regular check-up in the outpatient clinic\n* HCL use (MiniMed 780G, Tandem Control-IQ or Ypsomed CamAPS) \\>3 months\n* duration of T1D \\>2 years\n* baseline HbA1c level \\<58 mmol/mol (7.5%)\n* weight \\> 30 kilograms\n* without any medication influencing glycemia (f.e. gliflozins, systemic corticosteroids...)\n* signed informed consent form with the study"}, "identificationModule"=>{"nctId"=>"NCT06230276", "acronym"=>"NOELLE", "briefTitle"=>"Managing of Missed Meal Bolus by HCL Systems", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Motol"}, "officialTitle"=>"How do the Currently Available HCL Systems Manage Missed Meal Bolus? The Comparison of Glycemic Outcomes After Missed Meal Bolus Between MiniMed 780G, Tandem Control-IQ and Ypsomed CamAPS", "orgStudyIdInfo"=>{"id"=>"1B_23N01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention with and without premeal bolus", "interventionNames"=>["Other: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast"]}], "interventions"=>[{"name"=>"enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast", "type"=>"OTHER", "description"=>"Participants who are already treated by one of the HCL systems (MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS) will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.", "armGroupLabels"=>["Intervention with and without premeal bolus"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"15006", "city"=>"Prague", "status"=>"RECRUITING", "country"=>"Czechia", "contacts"=>[{"name"=>"Alžbeta Šantová, MD", "role"=>"CONTACT", "email"=>"alzbetkasantova@gmail.com", "phone"=>"+420773707270"}], "facility"=>"Motol University Hospital", "geoPoint"=>{"lat"=>50.08804, "lon"=>14.42076}}], "centralContacts"=>[{"name"=>"Alžbeta Šantová, MD", "role"=>"CONTACT", "email"=>"alzbetkasantova@gmail.com", "phone"=>"+420 773 707 270"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Zdeněk Šumník", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Head of the Department of Pediatrics", "investigatorFullName"=>"Zdeněk Šumník", "investigatorAffiliation"=>"University Hospital, Motol"}}}}