The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart and Insulin Lispro.

It had two arms (groups): IPF (active comparator) and one (experimental).

Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).

The registry classes the interventions as drug.

Who Took Part

The registry lists 76 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Duration of type 1 diabetes longer than 12 months. Insulin pump therapy longer than 3 months. Treated by the same type of insulin longer than 3 months. Written informed consent by patients and parents.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: celiac disease; diabetes related complications (e.g. nephropathy); any disease judged by the investigator to affect the trial.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-10-01 with completion listed for 2024-03-27.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Postprandial glycemia (time frame: 30 minutes after meal). Postprandial glycemia (time frame: 60 minutes after meal). Postprandial glycemia (time frame: 90 minutes after meal).

It also tracked 4 secondary outcomes, for example Glucose Area Under the Curve (AUC), The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE), Hypoglycemia Episodes and Time in target postprandial glycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Lispro in 76 people.

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 and the Insulin Lispro compound page, all human trials.