Fast-Acting Insulin Aspart and Insulin Pump Settings

Phase 4

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin aspart; Drug: Fast-acting insulin aspart

• Registration Number: NCT04620967
• Lead Sponsor: Kirsten Nørgaard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Status Verified: 2021-02
• Study Start: 2021-02-01
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fiasp-Iasp	Fast-acting insulin aspart	First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp
Iasp-Fiasp	Fast-acting insulin aspart	First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp
Iasp-Fiasp	Insulin aspart	First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp
Fiasp-Iasp	Insulin aspart	First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp

Primary Outcome Measures

Name	Time	Method
Time in range	Last two weeks of the 16-week interventions	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

Secondary Outcome Measures

Name	Time	Method
Mean glucose	Last two weeks of the 16-week interventions	Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time below range level 1	Last two weeks of the 16-week interventions	Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Total daily bolus insulin dose	Last two weeks of the 16-week interventions	Difference between Fiasp and Iasp treatment in total daily bolus insulin dose
Coefficient of variation	Last two weeks of the 16-week interventions	Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time above range level 1	Last two weeks of the 16-week interventions	Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Time above range level 2	Last two weeks of the 16-week interventions	Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Total daily insulin dose	Last two weeks of the 16-week interventions	Difference between Fiasp and Iasp treatment in total daily insulin dose
Total daily basal insulin dose	Last two weeks of the 16-week interventions	Difference between Fiasp and Iasp treatment in total daily basal insulin dose
Time below range level 2	Last two weeks of the 16-week interventions	Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Severe hypoglycemia	16 weeks	Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events
Ketoacidosis	16 weeks	Difference between Fiasp and Iasp treatment in number of ketoacidosis events
Fructosamine	16 weeks	Difference in change in fructosamine between Fiasp and Iasp treatment

Trial Locations

Locations (1)

Steno Diabetes Center Copenhagen; 🇩🇰 Gentofte, Denmark