Type 1 Diabetes
Conditions
Keywords
Insulin pump
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.
Interventions
DRUGInsulin aspart
Insulin aspart (Iasp) in insulin pump
Fast-acting insulin aspart (Fiasp) in insulin pump
Sponsors
Kirsten Nørgaard
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | Last two weeks of the 16-week interventions | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of variation | Last two weeks of the 16-week interventions | Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring |
| Time below range level 1 | Last two weeks of the 16-week interventions | Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring |
| Time below range level 2 | Last two weeks of the 16-week interventions | Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring |
| Time above range level 1 | Last two weeks of the 16-week interventions | Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring |
| Time above range level 2 | Last two weeks of the 16-week interventions | Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring |
| Mean glucose | Last two weeks of the 16-week interventions | Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring |
| Total daily insulin dose | Last two weeks of the 16-week interventions | Difference between Fiasp and Iasp treatment in total daily insulin dose |
| Total daily basal insulin dose | Last two weeks of the 16-week interventions | Difference between Fiasp and Iasp treatment in total daily basal insulin dose |
| Total daily bolus insulin dose | Last two weeks of the 16-week interventions | Difference between Fiasp and Iasp treatment in total daily bolus insulin dose |
| Severe hypoglycemia | 16 weeks | Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events |
| Ketoacidosis | 16 weeks | Difference between Fiasp and Iasp treatment in number of ketoacidosis events |
| Fructosamine | 16 weeks | Difference in change in fructosamine between Fiasp and Iasp treatment |
Countries
Denmark
Contacts
Primary ContactSigne Schmidt, MD PhD
Outcome results
None listed