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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449839

Enrollment

Registered

2007-03-21

Start date

2007-04-30

Completion date

2008-10-31

Last updated

2009-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Insulin pump treatment CSII, Absorption, Insulin Aspart

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.

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.

Interventions

DRUGInsulin 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Informed consent * Healthy volunteer * Men and women between ≥18 and \<50 years * Women in the child-bearing age should be sufficient protected against pregnancy (use birth control pill or intrauterine device or be sterilized or hysterectomized) * BMI between 18-30 kg/m\^2 (both included)

Exclusion criteria

* Suspected or known allergy against the drug used in the study or similar drugs * Previous history of endocrinology disease (including Diabetes Mellitus) * Suspected or known alcohol- or drug abuse * Any disease influencing the study, evaluated by the investigator * Pregnancy, breast-feeding or the wish of becoming pregnant during the study period. Furthermore women in the child bearing age not sufficient protected against pregnancy (sufficient is: use of birth control pill or intrauterine device or be sterilized or hysterectomized) * Participation in other research projects during the last 3 months before this project

Design outcomes

Primary

Measure	Time frame
Absorbed Insulin Aspart	one year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026