Fast-Acting Insulin Aspart and Insulin Pump Settings

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Insulin aspart; Drug: Fast-acting insulin aspart

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Signe Schmidt, MD PhD; Phone Number: +45 51174785; Email: signe.schmidt@regionh.dk

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Recruiting
    • Steno Diabetes Center Copenhagen
    • Contact: Signe Schmidt, MD PhD; Phone Number: +45 51174785; Email: signe.schmidt@regionh.dk
    • Sub-Investigator: Ajenthen Ranjan, MD PhD
    • Sub-Investigator: Hanne-Charlotte Andersen, RN
    • Sub-Investigator: Signe Schmidt, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kirsten Nørgaard
• Investigators: Principal Investigator: Kirsten Nørgaard, MD DMSc, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Insulin pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: 2020-001158-23; H-20022359 (Other Identifier: Scientific Ethical Committee of the Capital Region of Denmark)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No