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Clinical Trial Details

Trial ID: L5023
Source ID: NCT04019821
Associated Drug: Insulin Glulisine
Title: Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Insulin Glulisine|DRUG: Insulin Aspart|DRUG: Insulin Lispro
Outcome Measures: Primary: Postprandial Glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG), 90 minutes after the prandial bolus | Secondary: Hypoglycemia Episodes, Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms, 3-hours after the prandial bolus|Glucose Area Under the Curve (AUC), Measurements based on Continuous Glucose Monitoring System (CGMS), 3-hours after the prandial bolus|Mean amplitude of glycaemic excursion (MAGE), MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations, 3-hours after the prandial bolus|Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus, measured by SMBG, 3-hours after the prandial bolus|Glycemic rise (GR), a difference between baseline and the maximum glucose value based on CGMS, 3-hours after the prandial bolus|Peak glucose level (PG), the maximum value of glycemia during 3 hours of postmeal time based on CGMS, 3-hours after the prandial bolus|Time to glucose peak, based on CGMS, 3-hours after the prandial bolus|Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L), based on CGMS, 3-hours after the prandial bolus
Sponsor/Collaborators: Sponsor: Medical University of Warsaw
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-01-01
Completion Date: 2023-04-01
Results First Posted:
Last Update Posted: 2023-11-30
Locations: Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital, Warsaw, Poland
URL: https://clinicaltrials.gov/show/NCT04019821