Changes of the Infusion Rate in Insulin Pump Treatment

What Was Tested

The trial (phase 4) is built around 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 had three arms (groups): A, CSII without bolus (other), B; CSII with bolus (other) and C; CSII with bolus, optional (other).

A constant subcutaneous insulin aspart infusion is given for 8 hours and upon start a bolus of insulin aspart is given. The bolus in arm C is of a different size then arm B. After the 8 hours of constant infusion follows 3 hours of blood sampling. Period C are optional and it is evaluated if it will be conducted after period A and B has been performed.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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).

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-04 with completion listed for 2008-10.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absorbed Insulin Aspart (time frame: one year).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.