Fast-Acting Insulin Aspart and Insulin Pump Settings

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620967
• Other study ID #: 2020-001158-23
• Secondary ID: H-20022359
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: Steno Diabetes Center Copenhagen
• Contact: Signe Schmidt, MD PhD
• Phone: +45 51174785
• Email: signe.schmidt[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin aspart
Insulin aspart (Iasp) in insulin pump
• Fast-acting insulin aspart
Fast-acting insulin aspart (Fiasp) in insulin pump

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Kirsten Nørgaard

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fructosamine	Difference in change in fructosamine between Fiasp and Iasp treatment	16 weeks
Secondary	Total daily insulin dose	Difference between Fiasp and Iasp treatment in total daily insulin dose	Last two weeks of the 16-week interventions
Secondary	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
Secondary	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
Secondary	Severe hypoglycemia	Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events	16 weeks
Secondary	Ketoacidosis	Difference between Fiasp and Iasp treatment in number of ketoacidosis events	16 weeks