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

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

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

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Fiasp; Drug: Novorapid; Device: 640G pump

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54246
    • Aristotle University Of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fiasp/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	Drug: Fiasp; Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter; Drug: Novorapid; Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter; Device: 640G pump; MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link
Active Comparator: Novorapid/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	Drug: Fiasp; Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter; Drug: Novorapid; Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter; Device: 640G pump; MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2019
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): April 15, 2020

Study Registration Dates

• First Submitted: October 26, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: AUTH-AC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No