Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?
NCT ID: NCT04772729
Last Updated: 2021-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
77 participants
INTERVENTIONAL
2021-03-01
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Insulin Aspart
Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.
Insulin faster aspart (Fiasp, Novo Nordisk)
Duration of the study: 10 weeks.
It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.
W0: The study will start with a 2-week run-in period in order to normalize glycemia.
W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.
W2: after 2 weeks, diabetology telephone consultation (washout period).
W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.
W4: after 2 weeks, diabetology telephone consultation (washout period).
W5: after 2 weeks, diabetology telephone consultation.
W6: the results obtained throughout the study will be discussed with the patient and the parent.
Insulin Fiasp
Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks.
Insulin faster aspart (Fiasp, Novo Nordisk)
Duration of the study: 10 weeks.
It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.
W0: The study will start with a 2-week run-in period in order to normalize glycemia.
W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.
W2: after 2 weeks, diabetology telephone consultation (washout period).
W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.
W4: after 2 weeks, diabetology telephone consultation (washout period).
W5: after 2 weeks, diabetology telephone consultation.
W6: the results obtained throughout the study will be discussed with the patient and the parent.
Interventions
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Insulin faster aspart (Fiasp, Novo Nordisk)
Duration of the study: 10 weeks.
It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.
W0: The study will start with a 2-week run-in period in order to normalize glycemia.
W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.
W2: after 2 weeks, diabetology telephone consultation (washout period).
W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.
W4: after 2 weeks, diabetology telephone consultation (washout period).
W5: after 2 weeks, diabetology telephone consultation.
W6: the results obtained throughout the study will be discussed with the patient and the parent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
* using continuous glucose monitoring system for at least 1 month;
* HbA1c\<8%;
* consent to participate in the study obtained from the parent and the patient (\>16 years of age).
Exclusion Criteria
* concomitant medical problems which might significantly affect glucose levels;
* the withdrawal of the consent to participate in the study.
6 Years
17 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Agnieszka Szypowska, Prof.
Role: STUDY_CHAIR
Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland
Central Contacts
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Other Identifiers
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TIR: Fiasp vs. Asp
Identifier Type: -
Identifier Source: org_study_id