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Clinical Trial NCT04620967 for Type 1 Diabetes is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Fast-Acting Insulin Aspart and Insulin Pump Settings Phase 4 40
Clinical Trial NCT04620967 is designed to study Treatment for Type 1 Diabetes. It is a Phase 4 interventional study that is unknown status, having started on 1 February 2021, with plans to enroll 40 participants. Led by Kirsten Nørgaard, it is expected to complete by 30 June 2022. The latest data from ClinicalTrials.gov was last updated on 16 February 2021.
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:
- 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.
- to determine differences in insulin pu...
Official Title
Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY
Conditions
Type 1 DiabetesOther Study IDs
- 2020-001158-23
- H-20022359 (Other Identifier) (Scientific Ethical Committee of the Capital Region of Denmark)
NCT ID Number
Start Date (Actual)
2021-02-01
Last Update Posted
2021-02-16
Completion Date (Estimated)
2022-06-30
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 4
Status
Unknown status
Keywords
Insulin pump
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIasp-Fiasp First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp | Insulin aspart Insulin aspart (Iasp) in insulin pump Fast-acting insulin aspart Fast-acting insulin aspart (Fiasp) in insulin pump |
ExperimentalFiasp-Iasp First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp | Insulin aspart Insulin aspart (Iasp) in insulin pump Fast-acting insulin aspart Fast-acting insulin aspart (Fiasp) in insulin pump |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean glucose | Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Coefficient of variation | Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time below range level 1 | Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time below range level 2 | Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time above range level 1 | Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time above range level 2 | Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Fructosamine | Difference in change in fructosamine between Fiasp and Iasp treatment | 16 weeks |
Total daily insulin dose | Difference between Fiasp and Iasp treatment in total daily insulin dose | Last two weeks of the 16-week interventions |
Total daily basal insulin dose | Difference between Fiasp and Iasp treatment in total daily basal insulin dose | Last two weeks of the 16-week interventions |
Total daily bolus insulin dose | Difference between Fiasp and Iasp treatment in total daily bolus insulin dose | Last two weeks of the 16-week interventions |
Severe hypoglycemia | Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events | 16 weeks |
Ketoacidosis | Difference between Fiasp and Iasp treatment in number of ketoacidosis events | 16 weeks |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Kirsten NørgaardStudy Responsible Party
Kirsten Nørgaard, Sponsor-Investigator, Senior Consultant, Steno Diabetes Center Copenhagen
Study Central Contact
Contact: Signe Schmidt, MD PhD, +45 51174785, [email protected]
1 Study Locations in 1 Countries
Steno Diabetes Center Copenhagen, Gentofte Municipality, 2820, Denmark
Signe Schmidt, MD PhD, Contact, +45 51174785, [email protected]
Ajenthen Ranjan, MD PhD, Sub-Investigator
Hanne-Charlotte Andersen, RN, Sub-Investigator
Signe Schmidt, MD PhD, Sub-Investigator
Recruiting