Overview

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

Status:
Unknown status
Trial end date:
2020-04-15
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aristotle University Of Thessaloniki
Treatments:
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Long-Acting
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