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Clinical Trial Details

Trial ID: L4700
Source ID: NCT04124302
Associated Drug: Insulin Glulisine
Title: The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.
Acronym:
Status: UNKNOWN
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)., 60 minutes after meal|Postprandial glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)., 120 minutes after meal|Postprandial glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)., 180 minutes after meal|Postprandial glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)., 210 minutes after meal|Postprandial glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)., 240 minutes after meal|Postprandial glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)., 270 minutes after meal|Postprandial glycemia, Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)., 300 minutes after meal | Secondary: Glucose Area Under the Curve (AUC), Measurements based on Continuous Glucose Monitoring System (CGMS), 5 hours study period|The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE), Measurements based on SMBG, 5 hours study period|Hypoglycemia Episodes, Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms, 5 hours study period
Sponsor/Collaborators: Sponsor: Medical University of Warsaw
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-11
Completion Date: 2023-08
Results First Posted:
Last Update Posted: 2019-10-11
Locations:
URL: https://clinicaltrials.gov/show/NCT04124302