Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3774
Source ID: NCT04620967
Associated Drug: Insulin Aspart
Title: Fast-Acting Insulin Aspart and Insulin Pump Settings
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Insulin aspart|DRUG: Fast-acting insulin aspart
Outcome Measures: Primary: Time 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, Last two weeks of the 16-week interventions | Secondary: Mean glucose, Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring, 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, 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, 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, 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, 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, Last two weeks of the 16-week interventions|Fructosamine, Difference in change in fructosamine between Fiasp and Iasp treatment, 16 weeks|Total daily insulin dose, Difference between Fiasp and Iasp treatment in total daily insulin dose, 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, 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, Last two weeks of the 16-week interventions|Severe hypoglycemia, Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events, 16 weeks|Ketoacidosis, Difference between Fiasp and Iasp treatment in number of ketoacidosis events, 16 weeks
Sponsor/Collaborators: Sponsor: Kirsten Nørgaard
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-02-01
Completion Date: 2022-06-30
Results First Posted:
Last Update Posted: 2021-02-16
Locations: Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark
URL: https://clinicaltrials.gov/show/NCT04620967