Fast-Acting Insulin Aspart and Insulin Pump Settings

Kirsten Nørgaard

Status and phase: Unknown; Phase 4

Conditions: Type 1 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04620967

H-20022359 (Other Identifier)

2020-001158-23

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Iasp-Fiasp

Experimental group

Description:

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

Treatment:

Drug: Insulin aspart

Drug: Fast-acting insulin aspart

Fiasp-Iasp

Experimental group

Description:

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

Treatment:

Drug: Insulin aspart

Drug: Fast-acting insulin aspart