Fast-Acting Insulin Aspart and Insulin Pump Settings

Study Overview
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Brief Summary
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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: 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. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.

Official Title
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Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin aspart
* Drug: Fast-acting insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes for ≥ 5 years HbA1c 53-75 mmol/mol (7.0-9.0%) Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion) CGM use for ≥ 6 months (all CGM makes are eligible for inclusion) Carbohydrate counting for all snacks and meals Use of the insulin pump bolus calculator for all meals and snacks Exclusion Criteria: Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods Gastroparesis (clinical assessment) Shift work Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns Use of a hybrid closed-loop system Use of flash glucose monitoring Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start Chronic paracetamol use Alcohol or drug abuse Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol Impaired renal function (eGFR< 60 ml/min/1.73 m2) History of local skin reactions to Fiasp and/or Iasp Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation Lack of compliance with key study procedures at the discretion of the investigator Unacceptable adverse events at the discretion of the investigator Less than 40 weeks guarantee remaining on insulin pump

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iasp-Fiasp<br>First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp | Drug: Insulin aspart<br>* Insulin aspart (Iasp) in insulin pump<br>Drug: Fast-acting insulin aspart<br>* Fast-acting insulin aspart (Fiasp) in insulin pump<br>|
| Experimental: Fiasp-Iasp<br>First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp | Drug: Insulin aspart<br>* Insulin aspart (Iasp) in insulin pump<br>Drug: Fast-acting insulin aspart<br>* Fast-acting insulin aspart (Fiasp) in insulin pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin pump