Clinical trial NCT04620967: Fast-Acting Insulin Aspart and Insulin Pump Settings
Official title: Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Insulin pump
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time in range
timeFrame: Last two weeks of the 16-week interventions
Secondary outcomes:
measure: Mean glucose
timeFrame: Last two weeks of the 16-week interventions
measure: Coefficient of variation
timeFrame: Last two weeks of the 16-week interventions
measure: Time below range level 1
timeFrame: Last two weeks of the 16-week interventions
measure: Time below range level 2
timeFrame: Last two weeks of the 16-week interventions
measure: Time above range level 1
timeFrame: Last two weeks of the 16-week interventions
measure: Time above range level 2
timeFrame: Last two weeks of the 16-week interventions
measure: Fructosamine
timeFrame: 16 weeks
measure: Total daily insulin dose
timeFrame: Last two weeks of the 16-week interventions
measure: Total daily basal insulin dose
timeFrame: Last two weeks of the 16-week interventions
measure: Total daily bolus insulin dose
timeFrame: Last two weeks of the 16-week interventions
measure: Severe hypoglycemia
timeFrame: 16 weeks
measure: Ketoacidosis
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Kirsten Nørgaard, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References: