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De klinische studie NCT04620967 voor Type 1 diabetes is onbekend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Fast-Acting Insulin Aspart and Insulin Pump Settings Fase 4 40
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De klinische studie NCT04620967 onderzoekt behandeling bij Type 1 diabetes. Deze Fase 4 interventioneel-studie heeft de status onbekend. Het doel is om 40 deelnemers te includeren vanaf 1 februari 2021. De studie wordt geleid door Kirsten Nørgaard en de voltooiing is gepland op 30 juni 2022. Laatste update op ClinicalTrials.gov: 16 februari 2021.
Beknopte samenvatting
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...
Officiële titel
Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY
Aandoeningen
Type 1 diabetesAndere studie-ID's
- 2020-001158-23
- H-20022359 (Overige identificatiecode) (Scientific Ethical Committee of the Capital Region of Denmark)
NCT-ID
Startdatum (Werkelijk)
2021-02-01
Laatste update geplaatst
2021-02-16
Verwachte einddatum
2022-06-30
Inschrijving (Geschat)
40
Studietype
Interventioneel
FASE
Fase 4
Status
Onbekend
Trefwoorden
Insulin pump
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Drievoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelIasp-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 |
ExperimenteelFiasp-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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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 NørgaardVerantwoordelijke instantie
Kirsten Nørgaard, Sponsor-Onderzoeker, Senior Consultant, Steno Diabetes Center Copenhagen
Centraal Contactpersoon
Contact: Signe Schmidt, MD PhD, +45 51174785, [email protected]
1 Studielocaties in 1 landen
Steno Diabetes Center Copenhagen, Gentofte Municipality, 2820, Denmark
Signe Schmidt, MD PhD, Contact, +45 51174785, [email protected]
Ajenthen Ranjan, MD PhD, Subonderzoeker
Hanne-Charlotte Andersen, RN, Subonderzoeker
Signe Schmidt, MD PhD, Subonderzoeker
Rekruterend