Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.

What Was Tested

The trial (phase 4) is built around Insulin Aspart and Insulin Lispro.

This is a randomized, cross-over study.

The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.

Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.

It had two arms (groups): group A (placebo comparator) and group B (active comparator).

The registry classes the interventions as drug.

More on the Plan

The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient.

Pure protein meal will be given 3 hours after a first breakfast.

Meal insulin will be given as a square bolus or no meal -insulin will be given at all.

The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS).

Who Took Part

70 planned participants were the target.

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. Written informed consent by patients and parents.

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

How the Study Was Run

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

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 2016-02 with completion listed for 2018-02.

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: 30 minutes after the meal). Postprandial glycemia (time frame: 60 minutes after the meal). Postprandial glycemia (time frame: 90 minutes after the meal).

It also tracked 4 secondary outcomes, for example Hypoglycemia episodes, Glucose Area Under the Curve (AUC), Mean amplitude of glycemic excursion and The difference between the maximum and baseline glucose level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Lispro in 70 people.

Its status is unknown; 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.