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

Phase 4

• Conditions: Type 1 Diabetes
• Interventions: Drug: Fiasp; Drug: Novorapid; Device: 640G pump

• Registration Number: NCT04149262
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

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®.

Study Timeline

• Study First Submitted: 2019-10-26
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-01
• Last Update Submitted: 2019-11-01
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-04
• Study Start: 2019-11-15
• Primary Completion: 2020-03-31
• Study Completion: 2020-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Informed consent obtained by parents or legal caregivers before any trial-related activities.
2. Any age, age ≥ 2 years and age <18 years at the time of signing informed consent
3. Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study
4. 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.
5. Ability and willingness to use the same insulin infusion sets throughout the trial
6. Using the same insulin for at least 30 days prior to screening
7. HbA1c < 9.0% as assessed by local laboratory at screening
8. 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

1. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
2. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening
3. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
4. Any diabetic complication including renal disease, retinopathy, etc
5. History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening
6. Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fiasp/Novorapid	640G pump	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
Novorapid/Fiasp	640G pump	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
Fiasp/Novorapid	Novorapid	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
Novorapid/Fiasp	Novorapid	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
Fiasp/Novorapid	Fiasp	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
Novorapid/Fiasp	Fiasp	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

Primary Outcome Measures

Name	Time	Method
1-hour glucose levels on Fiasp	Weeks 1 to 4	ost-prandial 1-hour glucose levels on Fiasp® when used in the MiniMed 640G pump in children with type 1 diabetes.
1-hour glucose levels on Novorapid	Weeks 1 to 4	ost-prandial 1-hour glucose levels on Novorapid® when used in the MiniMed 640G pump in children with type 1 diabetes.

Secondary Outcome Measures

Name	Time	Method
Incidence of infusion sites reactions in Novorapid	Weeks 1 to 4	Number of reactions involving infusion sites during Fiasp® use
Occlusion events in Fiasp	Weeks 1 to 4	Number of occlusion events during Fiasp® use
Occlusion events in Novorapid	Weeks 1 to 4	Number of occlusion events during Novorapid® use
Hypoglycemia in Fiasp	Weeks 1 to 4	Percent of time spent below 70mg mg/dl during Fiasp® use
Half-hour glucose levels on Fiasp	Weeks 1 to 4	ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed
Half-hour glucose levels on Novorapid	Weeks 1 to 4	ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed
2 hours glucose levels on Fiasp	Weeks 1 to 4	ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed
2 hours glucose levels on Novorapid	Weeks 1 to 4	ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed
Time in Range in Fiasp	Weeks 1 to 4	Percent of time spent within 70-180 mg/dl during Fiasp® use
Time in Range in Novorapid	Weeks 1 to 4	Percent of time spent within 70-180 mg/dl during Novorapid® use
Hypoglycemia in Novorapid	Weeks 1 to 4	Percent of time spent below 70mg mg/dl during Novorapid® use
Total Daily Dose in Fiasp	Weeks 1 to 4	Units of insulin used per day during Fiasp® use
Total Daily Dose in Novorapid	Weeks 1 to 4	Units of insulin used per day during Novorapid® use
Basal/Bolus in Fiasp	Weeks 1 to 4	Units of insulin used per basal/bolus day during Fiasp® use
Basal/Bolus in Novorapid	Weeks 1 to 4	Units of insulin used per basal/bolus day during Novorapid® use
eHbA1c in Fiasp	Weeks 1 to 4	Estimated HbA1c levels during Fiasp® use
eHbA1c in Novorapid	Weeks 1 to 4	Estimated HbA1c levels during Novorapid® use
Incidence of infusion sites reactions in Fiasp	Weeks 1 to 4	Number of reactions involving infusion sites during Fiasp® use

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece