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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04149262
• Other study ID #: AUTH-AC-1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 15, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: November 2019
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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®.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 15, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Fiasp
Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
• 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

Locations

Country	Name	City	State
Greece	Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

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