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| ID | Type | Description | Link |
|---|---|---|---|
| H-20022359 | Other Identifier | Scientific Ethical Committee of the Capital Region of Denmark |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iasp-Fiasp | Experimental | First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp |
|
| Fiasp-Iasp | Experimental | First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin aspart | Drug | Insulin aspart (Iasp) in insulin pump |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Signe Schmidt, MD PhD | Contact | +45 51174785 | signe.schmidt@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Nørgaard, MD DMSc | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Recruiting | Gentofte Municipality | 2820 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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A randomized, double-blind, cross-over study with two 16-week intervention periods separated by a 3-week washout period comparing Fiasp with Iasp in adults with type 1 diabetes treated with insulin pump and CGM.
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Group allocation is concealed to participants as well as investigators until all participants have completed the study. The allocation for a participant may be revealed in a medical emergency if knowledge about the treatment allocation would influence the treatment of the person.
| Fast-acting insulin aspart |
| Drug |
Fast-acting insulin aspart (Fiasp) in insulin pump |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |