An interventional study of Fiasp and Novorapid in Type 1 Diabetes, sponsored by University of Ljubljana, Faculty of Medicine. Completed at 2 sites in 2 countries. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of Ljubljana, Faculty of Medicine · Not applicable, Interventional, and Treatment
A double-blind, multinational, multicenter, randomised, 2-period crossover study to assess the efficacy and safety of advanced closed-loop insulin delivery with Minimed 670G 4.0 system comparing Faster Insulin Aspart to Standard Insulin Aspart therapy over 4 weeks in active children and adolescents with type 1 diabetes.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Ljubljana, Faculty of Medicine is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Drug: Fiasp
Drug: Novorapid
Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid
Time above range 180 mg/dl
The primary outcomes is a difference in CGM-measured metrics between periods (Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart) in superiority for proportion of time \>180 mg/dL (10.0 mmol/L)
Time frame: 12 weeks for each arm of the crossover
Time in range 70-180 mg/dl
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in time in range 70 to 180 mg/dL (3.9 to 10.0 mmol/L
Time frame: 4 weeks for each arm of the crossover
Time below range <70 mg/dl
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in time below range 70 mg/dl
Time frame: 4 weeks for each arm of the crossover
Mean glucose
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in mean glucose
Time frame: 4 weeks for each arm of the crossover
Plan to share: Undecided
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Ljubljana, Faculty of Medicine