Back to resultsFiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
Primary Purpose
Type 1 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Fiasp
Novorapid
640G pump
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- Aristotle University of Thessaloniki
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fiasp/Novorapid
Novorapid/Fiasp
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Half-hour glucose levels on Fiasp
ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed
Half-hour glucose levels on Novorapid
ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed
2 hours glucose levels on Fiasp
ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed
2 hours glucose levels on Novorapid
ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed
Time in Range in Fiasp
Percent of time spent within 70-180 mg/dl during Fiasp® use
Time in Range in Novorapid
Percent of time spent within 70-180 mg/dl during Novorapid® use
Hypoglycemia in Fiasp
Percent of time spent below 70mg mg/dl during Fiasp® use
Hypoglycemia in Novorapid
Percent of time spent below 70mg mg/dl during Novorapid® use
Total Daily Dose in Fiasp
Units of insulin used per day during Fiasp® use
Total Daily Dose in Novorapid
Units of insulin used per day during Novorapid® use
Basal/Bolus in Fiasp
Units of insulin used per basal/bolus day during Fiasp® use
Basal/Bolus in Novorapid
Units of insulin used per basal/bolus day during Novorapid® use
eHbA1c in Fiasp
Estimated HbA1c levels during Fiasp® use
eHbA1c in Novorapid
Estimated HbA1c levels during Novorapid® use
Incidence of infusion sites reactions in Fiasp
Number of reactions involving infusion sites during Fiasp® use
Incidence of infusion sites reactions in Novorapid
Number of reactions involving infusion sites during Fiasp® use
Occlusion events in Fiasp
Number of occlusion events during Fiasp® use
Occlusion events in Novorapid
Number of occlusion events during Novorapid® use
Full Information
NCT ID
NCT04149262
First Posted
October 26, 2019
Last Updated
November 1, 2019
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT04149262
Brief Title
Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
April 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
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
5. Study Description
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fiasp/Novorapid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Novorapid/Fiasp
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fiasp
Intervention Description
Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
Intervention Type
Drug
Intervention Name(s)
Novorapid
Intervention Description
Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
Intervention Type
Device
Intervention Name(s)
640G pump
Intervention Description
MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link
Primary Outcome Measure Information:
Title
1-hour glucose levels on Fiasp
Description
ost-prandial 1-hour glucose levels on Fiasp® when used in the MiniMed 640G pump in children with type 1 diabetes.
Time Frame
Weeks 1 to 4
Title
1-hour glucose levels on Novorapid
Description
ost-prandial 1-hour glucose levels on Novorapid® when used in the MiniMed 640G pump in children with type 1 diabetes.
Time Frame
Weeks 1 to 4
Secondary Outcome Measure Information:
Title
Half-hour glucose levels on Fiasp
Description
ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed
Time Frame
Weeks 1 to 4
Title
Half-hour glucose levels on Novorapid
Description
ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed
Time Frame
Weeks 1 to 4
Title
2 hours glucose levels on Fiasp
Description
ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed
Time Frame
Weeks 1 to 4
Title
2 hours glucose levels on Novorapid
Description
ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed
Time Frame
Weeks 1 to 4
Title
Time in Range in Fiasp
Description
Percent of time spent within 70-180 mg/dl during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Time in Range in Novorapid
Description
Percent of time spent within 70-180 mg/dl during Novorapid® use
Time Frame
Weeks 1 to 4
Title
Hypoglycemia in Fiasp
Description
Percent of time spent below 70mg mg/dl during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Hypoglycemia in Novorapid
Description
Percent of time spent below 70mg mg/dl during Novorapid® use
Time Frame
Weeks 1 to 4
Title
Total Daily Dose in Fiasp
Description
Units of insulin used per day during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Total Daily Dose in Novorapid
Description
Units of insulin used per day during Novorapid® use
Time Frame
Weeks 1 to 4
Title
Basal/Bolus in Fiasp
Description
Units of insulin used per basal/bolus day during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Basal/Bolus in Novorapid
Description
Units of insulin used per basal/bolus day during Novorapid® use
Time Frame
Weeks 1 to 4
Title
eHbA1c in Fiasp
Description
Estimated HbA1c levels during Fiasp® use
Time Frame
Weeks 1 to 4
Title
eHbA1c in Novorapid
Description
Estimated HbA1c levels during Novorapid® use
Time Frame
Weeks 1 to 4
Title
Incidence of infusion sites reactions in Fiasp
Description
Number of reactions involving infusion sites during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Incidence of infusion sites reactions in Novorapid
Description
Number of reactions involving infusion sites during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Occlusion events in Fiasp
Description
Number of occlusion events during Fiasp® use
Time Frame
Weeks 1 to 4
Title
Occlusion events in Novorapid
Description
Number of occlusion events during Novorapid® use
Time Frame
Weeks 1 to 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aristotle University of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54246
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
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