Fast-Acting Insulin Aspart and Insulin Pump Settings

NCT ID: NCT04620967

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-06-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Iasp-Fiasp

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

Group Type: EXPERIMENTAL

Insulin aspart

Intervention Type: DRUG

Insulin aspart (Iasp) in insulin pump

Fast-acting insulin aspart

Intervention Type: DRUG

Fast-acting insulin aspart (Fiasp) in insulin pump

Fiasp-Iasp

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

Group Type: EXPERIMENTAL

Insulin aspart

Intervention Type: DRUG

Insulin aspart (Iasp) in insulin pump

Fast-acting insulin aspart

Intervention Type: DRUG

Fast-acting insulin aspart (Fiasp) in insulin pump

Interventions

Insulin aspart

Insulin aspart (Iasp) in insulin pump

Intervention Type: DRUG

Fast-acting insulin aspart

Fast-acting insulin aspart (Fiasp) in insulin pump

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirsten Nørgaard

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Nørgaard

Senior Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kirsten Nørgaard, MD DMSc

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Signe Schmidt, MD PhD

Role: CONTACT

signe.schmidt@regionh.dk

+45 51174785

Facility Contacts

Signe Schmidt, MD PhD

Role: primary

signe.schmidt@regionh.dk

+45 51174785

Other Identifiers

H-20022359

Identifier Type: OTHER

Identifier Source: secondary_id

2020-001158-23

Identifier Type: -

Identifier Source: org_study_id