Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449839
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2007-03-20
Brief Title:
Changes of the Infusion Rate in Insulin Pump Treatment
Sponsor:
Aarhus University Hospital
Organization:
University of Aarhus
Study Overview
Official Title:
Changes of the Infusion Rate in Insulin Pump Treatment A Randomized Unblinded Cross-Over Study
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pharmacokinetic study of insulin pump treatment using Insulin Aspart The study consist of three different periods A B and C where a constant the insulin infusion rate is given during the periods In period B and C will the infusion start with a bolus
It will be investigated if a steady state of insulin will be obtained faster in period B and C then A
It will be investigated if a steady state of insulin will be obtained faster in period B and C then A
Detailed Description:
A pharmacokinetic study of insulin pump treatment using Insulin Aspart The study consist of three different periods A B and C where a constant the insulin infusion rate is given during the periods Each period will last 12 hours and blood will be drawn to measure absorbed Insulin Aspart During period A will a constant the infusion rate of insulin be given In period B and C will there at the start of the constant infusion rate be given a bolus The bolus in period C is calculated on the basis of the results in period B therefore will all participants experience period C last where as period A and B is randomized cross-over Period C is written in the protocol as optional and it is evaluated after period A and B if period C will be performed
The hypothesis is that steady state of insulin will be obtained faster in period B and C than A
The hypothesis is that steady state of insulin will be obtained faster in period B and C than A
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None