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
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
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®.
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