NCT00449839

Changes of the Infusion Rate in Insulin Pump Treatment

Changes of the Infusion Rate in Insulin Pump Treatment. A Randomized, Unblinded Cross-Over Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Insulin Aspart	A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus. C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-03-21
• Last updated: 2009-07-02

Locations

1 site across 1 country: Denmark