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

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Nov 1, 2019

Keywords

ClinConnect Summary

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...

Gender

ALL

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