Clinical trial NCT04149262: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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®.

Eligibility criteria: 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

Primary outcomes:
measure: 1-hour glucose levels on Fiasp
timeFrame: Weeks 1 to 4
measure: 1-hour glucose levels on Novorapid
timeFrame: Weeks 1 to 4
Secondary outcomes:
measure: Half-hour glucose levels on Fiasp
timeFrame: Weeks 1 to 4
measure: Half-hour glucose levels on Novorapid
timeFrame: Weeks 1 to 4
measure: 2 hours glucose levels on Fiasp
timeFrame: Weeks 1 to 4
measure: 2 hours glucose levels on Novorapid
timeFrame: Weeks 1 to 4
measure: Time in Range in Fiasp
timeFrame: Weeks 1 to 4
measure: Time in Range in Novorapid
timeFrame: Weeks 1 to 4
measure: Hypoglycemia in Fiasp
timeFrame: Weeks 1 to 4
measure: Hypoglycemia in Novorapid
timeFrame: Weeks 1 to 4
measure: Total Daily Dose in Fiasp
timeFrame: Weeks 1 to 4
measure: Total Daily Dose in Novorapid
timeFrame: Weeks 1 to 4
measure: Basal/Bolus in Fiasp
timeFrame: Weeks 1 to 4
measure: Basal/Bolus in Novorapid
timeFrame: Weeks 1 to 4
measure: eHbA1c in Fiasp
timeFrame: Weeks 1 to 4
measure: eHbA1c in Novorapid
timeFrame: Weeks 1 to 4
measure: Incidence of infusion sites reactions in Fiasp
timeFrame: Weeks 1 to 4
measure: Incidence of infusion sites reactions in Novorapid
timeFrame: Weeks 1 to 4
measure: Occlusion events in Fiasp
timeFrame: Weeks 1 to 4
measure: Occlusion events in Novorapid
timeFrame: Weeks 1 to 4
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
References: