Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Aspart | Active Comparator | Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks. |
|
| Insulin Fiasp | Experimental | Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin faster aspart (Fiasp, Novo Nordisk) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemia difference in time in range (TIR) 70-180mg/dl | at week 4 of the study | |
| Glycaemia difference in time in range (TIR) 70-180mg/dl | at week 8 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemia difference in time below range (TBR) | at weeks 4 and 8 of the study | |
| Glycaemia difference in time above range (TAR) | at weeks 4 and 8 of the study | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilia Kowalczyk, MD | Contact | +48 223179538 | emilia.kowalczyk@uckwum.pl | |
| Agnieszka Szypowska, Prof. | Contact | +48 223179539 | agnieszka.szypowska@uckwum.pl |
| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szypowska, Prof. | Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland | Study Chair |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
A cross-over, open-label, randomized study.
Not provided
Not provided
Not provided
Not provided
|
|
| Glycaemia difference in the coefficient of variation (CV) |
| at weeks 4 and 8 of the study |
| Difference in the average glycemia levels + standard deviation | at weeks 4 and 8 of the study |
| Difference in Total Daily Dose (TDD) of insulin | at weeks 4 and 8 of the study |
| Difference in the basal rate of insulin | at weeks 4 and 8 of the study |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |