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De klinische studie NCT01454700 voor Type 1 diabetes mellitus is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Effect of CSII and CGM on Progression of Late Diabetic Complications Fase 4 60
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De klinische studie NCT01454700 onderzocht behandeling bij Type 1 diabetes mellitus. Deze Fase 4 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 60 deelnemers vanaf 1 december 2011. De studie werd geleid door Steen Andersen en was gepland te worden voltooid op 1 december 2014. Laatste update op ClinicalTrials.gov: 14 januari 2015.
Beknopte samenvatting
The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes
Uitgebreide beschrijving
80 type 1 diabetic patients with kidney function (GFR > 45 ml/min), but with urine albumin excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the study.
Before the study is initiated all patients rec...
Toon meerOfficiële titel
The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus
Aandoeningen
Type 1 diabetes mellitusPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- H-3-2011-122
NCT-ID
Startdatum (Werkelijk)
2011-12
Laatste update geplaatst
2015-01-14
Verwachte einddatum
2014-12
Inschrijving (Geschat)
60
Studietype
Interventioneel
FASE
Fase 4
Status
Afgerond
Trefwoorden
Type 1 diabetes mellitus
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelCSII plus CGM Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring. | Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) Randomization to 12 months with CSII plus CGM |
Actieve comparatorMultiple daily insulin injections randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). | Multiple daily insulin injections (MDI) Randomization12 months therapy with MDI |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
difference in change in urine albumine excretion from baseline to end of study (12 months) | Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months. | 12 months |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
difference in change of HbA1c from baseline to 12 months | 12 months | |
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles | 12 months | |
difference in change of 24-hour blood pressure | 12 months | |
difference in change of glomerular filtration rate (GFR) | 12 months | |
difference in the occurence or progression of retinopathy | 12 months | |
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP | 12 months | |
difference in endothelial cell dysfunction | 12 months | |
difference in carotid intima media thickness (CIMT) | 12 months |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 18-75 years of age,
- Type 1 diabetes according to WHO criteria,
- Urin albumine > 30 mg/g (albumine/creatinine ratio),
- HbA1c > 7.5 < 13.0%,
- No change in RAAS blocking treatment at least 4 weeks prior to screening.
- Kidney disease other that diabetic nephropathy,
- Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
- Use of insulin pump within 12 months,
- Acute myocardial infarction within 3 months,
- Severe arteriosclerosis as judged by the investigator,
- Heart failure (NYHA class 3 or 4),
- Abuse of alcohol or drugs,
- Any cancer diagnosis unless in remission at least 5 years prior to screening,
- Participation in other intervention studies,
- Pregnant or lactating women,
- Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.
Steen AndersenMedtronicVerantwoordelijke instantie
Steen Andersen, Sponsor-Onderzoeker, Chief physician, DMSc, Steno Diabetes Center Copenhagen
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Copenhagen
Steno Diabetes Center, Gentofte Municipality, Copenhagen, 2820, Denmark