To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed. The aim of this study is twofold: 1. to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy. 2. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Insulin aspart (Iasp) in insulin pump
Fast-acting insulin aspart (Fiasp) in insulin pump
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
RECRUITINGTime in range
Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time frame: Last two weeks of the 16-week interventions
Mean glucose
Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time frame: Last two weeks of the 16-week interventions
Coefficient of variation
Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time frame: Last two weeks of the 16-week interventions
Time below range level 1
Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time frame: Last two weeks of the 16-week interventions
Time below range level 2
Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time frame: Last two weeks of the 16-week interventions
Time above range level 1
Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time frame: Last two weeks of the 16-week interventions
Time above range level 2
Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
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Time frame: Last two weeks of the 16-week interventions
Fructosamine
Difference in change in fructosamine between Fiasp and Iasp treatment
Time frame: 16 weeks
Total daily insulin dose
Difference between Fiasp and Iasp treatment in total daily insulin dose
Time frame: Last two weeks of the 16-week interventions
Total daily basal insulin dose
Difference between Fiasp and Iasp treatment in total daily basal insulin dose
Time frame: Last two weeks of the 16-week interventions
Total daily bolus insulin dose
Difference between Fiasp and Iasp treatment in total daily bolus insulin dose
Time frame: Last two weeks of the 16-week interventions
Severe hypoglycemia
Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events
Time frame: 16 weeks
Ketoacidosis
Difference between Fiasp and Iasp treatment in number of ketoacidosis events
Time frame: 16 weeks