Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia

What Was Tested

The trial (not phased) is built around Insulin (regular human).

A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition.

Participants were asked to consume 10 different combinations of meal and bolus type.

It had two arms (groups): Adolescents with T1D on CSII (active comparator) and Healthy adolescents (no intervention).

3 standard meals with varying composition were consumed.

The registry classes the interventions as drug.

More on the Plan

The nutritional recommendations of children and adolescents with T1D should be similar to those of healthy people in order to achieve the desirable growth.

In order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII).

By using the CSII the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus.

The aim of this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals, in adolescents with T1D on CSII.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 11 years up to 20 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: subjects with eating disorders, food allergy, celiac disease and known diabetic complications.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2011-03 with completion listed for 2011-05.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: post-prandial euglycaemia (PPG) (time frame: 3 days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) 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 (regular human) compound page, all human trials.