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Clinical Trial Details

Trial ID: L2978
Source ID: NCT04149262
Associated Drug: Fiasp
Title: Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Fiasp|DRUG: Novorapid|DEVICE: 640G pump
Outcome Measures: Primary: 1-hour glucose levels on Fiasp, ost-prandial 1-hour glucose levels on Fiasp® when used in the MiniMed 640G pump in children with type 1 diabetes., Weeks 1 to 4|1-hour glucose levels on Novorapid, ost-prandial 1-hour glucose levels on Novorapid® when used in the MiniMed 640G pump in children with type 1 diabetes., Weeks 1 to 4 | Secondary: Half-hour glucose levels on Fiasp, ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed, Weeks 1 to 4|Half-hour glucose levels on Novorapid, ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed, Weeks 1 to 4|2 hours glucose levels on Fiasp, ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed, Weeks 1 to 4|2 hours glucose levels on Novorapid, ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed, Weeks 1 to 4|Time in Range in Fiasp, Percent of time spent within 70-180 mg/dl during Fiasp® use, Weeks 1 to 4|Time in Range in Novorapid, Percent of time spent within 70-180 mg/dl during Novorapid® use, Weeks 1 to 4|Hypoglycemia in Fiasp, Percent of time spent below 70mg mg/dl during Fiasp® use, Weeks 1 to 4|Hypoglycemia in Novorapid, Percent of time spent below 70mg mg/dl during Novorapid® use, Weeks 1 to 4|Total Daily Dose in Fiasp, Units of insulin used per day during Fiasp® use, Weeks 1 to 4|Total Daily Dose in Novorapid, Units of insulin used per day during Novorapid® use, Weeks 1 to 4|Basal/Bolus in Fiasp, Units of insulin used per basal/bolus day during Fiasp® use, Weeks 1 to 4|Basal/Bolus in Novorapid, Units of insulin used per basal/bolus day during Novorapid® use, Weeks 1 to 4|eHbA1c in Fiasp, Estimated HbA1c levels during Fiasp® use, Weeks 1 to 4|eHbA1c in Novorapid, Estimated HbA1c levels during Novorapid® use, Weeks 1 to 4|Incidence of infusion sites reactions in Fiasp, Number of reactions involving infusion sites during Fiasp® use, Weeks 1 to 4|Incidence of infusion sites reactions in Novorapid, Number of reactions involving infusion sites during Fiasp® use, Weeks 1 to 4|Occlusion events in Fiasp, Number of occlusion events during Fiasp® use, Weeks 1 to 4|Occlusion events in Novorapid, Number of occlusion events during Novorapid® use, Weeks 1 to 4
Sponsor/Collaborators: Sponsor: Aristotle University Of Thessaloniki
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-11-15
Completion Date: 2020-04-15
Results First Posted:
Last Update Posted: 2019-11-04
Locations: Aristotle University of Thessaloniki, Thessaloniki, 54246, Greece
URL: https://clinicaltrials.gov/show/NCT04149262