Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor

Study Overview
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Brief Summary
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This is an exploratory, single-center, open label, randomized, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoRapid® when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus

Detailed Description
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This study is designed to compare Fiasp® to NovoRapid® in children with T1DM wearing MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter in terms of glycemic control with a focus on post-prandial ½-hour and 1-hour plasma glucose levels. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period. Half, randomized subjects will have a 4 weeks screening period using NovoRapid® and then 4 weeks treatment period with Fiasp® whereas the rest of the participants will start the trial period with 4 weeks using Fiasp® followed by 4 weeks in NovoRapid®.

Official Title
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An Open Label, Single-center, Randomized, Cross-over Trial Comparing the Efficacy and Safety of Faster-acting Insulin Aspart (Fiasp®) Compared to Insulin Aspart (NovoRapid)® Used in the Medtronic MiniMed 640G Insulin Pump Equipped With Sensor

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Fiasp
* Drug: Novorapid
* Device: 640G pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained by parents or legal caregivers before any trial-related activities. Any age, age ≥ 2 years and age <18 years at the time of signing informed consent Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study Using the Medtronic MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial. Ability and willingness to use the same insulin infusion sets throughout the trial Using the same insulin for at least 30 days prior to screening HbA1c < 9.0% as assessed by local laboratory at screening Ability and willingness to adhere to the protocol including performing SMBG (Self Monitoring Blood Glucose) profiles, attending visits, uploading pump and sensor data to the CareLink platform Exclusion Criteria: Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial Any diabetic complication including renal disease, retinopathy, etc History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with the protocol

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fiasp/Novorapid<br>4 weeks on Fiasp® then crossover to 4 weeks on NovoRapid® in subjects on the MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter | Drug: Fiasp<br>* Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter<br>Drug: Novorapid<br>* Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter<br>Device: 640G pump<br>* MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link<br>|
| Active Comparator: Novorapid/Fiasp<br>4 weeks on NovoRapid® then crossover to 4 weeks on Fiasp® in subjects on the MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter | Drug: Fiasp<br>* Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter<br>Drug: Novorapid<br>* Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter<br>Device: 640G pump<br>* MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |