Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

What Was Tested

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

It had two arms (groups): Normal Bolus (active comparator) and Super Bolus (experimental).

Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 72 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 12months,. Insulin pump therapy longer than 3 months,. Written informed consent to participate in the study signed by parents (and patient older than 16 years).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: celiac disease,; diabetes related complications (e.g. nephropathy),; BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2020-01-01 with completion listed for 2023-01-01.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Postprandial Glycemia (time frame: 90 minutes after the prandial bolus).

It also tracked 8 secondary outcomes, for example Hypoglycemia Episodes, Glucose Area Under the Curve (AUC), Mean amplitude of glycaemic excursion (MAGE), Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus, Glycemic rise (GR) and Peak glucose level (PG).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Lispro in 72 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.