Fast-Acting Insulin Aspart and Insulin Pump Settings

NCT04620967 | Unknown Phase 4

• 2 other identifiers: 2020-001158-23H-20022359
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.

Conditions

Type 1 Diabetes

Keywords

Insulin pump

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Mean glucose

  Last two weeks of the 16-week interventions

• Coefficient of variation

  Last two weeks of the 16-week interventions

• Time below range level 1

  Last two weeks of the 16-week interventions

• Time below range level 2

  Last two weeks of the 16-week interventions

• Time above range level 1

  Last two weeks of the 16-week interventions

Study Arms (2)

Iasp-Fiasp

EXPERIMENTAL

First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp

Drug: Insulin aspart; Drug: Fast-acting insulin aspart

Fiasp-Iasp

EXPERIMENTAL

First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp

Drug: Insulin aspart; Drug: Fast-acting insulin aspart

Interventions

Insulin aspart DRUG

Insulin aspart (Iasp) in insulin pump

Fiasp-Iasp; Iasp-Fiasp

Fast-acting insulin aspart DRUG

Fast-acting insulin aspart (Fiasp) in insulin pump

Fiasp-Iasp; Iasp-Fiasp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes for ≥ 5 years
• HbA1c 53-75 mmol/mol (7.0-9.0%)
• Carbohydrate counting for all snacks and meals
• Use of the insulin pump bolus calculator for all meals and snacks

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsten Nørgaard: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kirsten Nørgaard, MD DMSc

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Signe Schmidt, MD PhD

CONTACT

+45 51174785; signe.schmidt@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: February 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

DK (1)