Normal Versus Dual Wave Insulin Bolus for High-protein Food

What Was Tested

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

Patients receive a standardized high-protein test meal at breakfast time.

Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump.

The 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 1 hour) and continuous glucose monitoring system (CGMS).

It had two arms (groups): Normal/ Dual-wave (experimental) and Dual-wave/Normal (experimental).

The registry classes the interventions as drug.

More on the Plan

The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient.

The aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus.

During this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave).

A high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery.

Who Took Part

Enrollment: 70 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. Written informed consent by patients and parents. Patients must be willing to wear a glucose sensor for two days.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: concomitant dietary restrictions (e.g. celiac disease or food allergy); diabetes related complications (e.g. nephropathy); any disease judged by the investigator to affect the trial.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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.

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

Only one side, usually the participants, was kept unaware of whether Insulin Aspart was given.

Those kept unaware of assignments: investigator.

It started in 2014-10 with completion listed for 2015-09.

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: 60 minutes after the meal). Postprandial glycemia (time frame: 120 minutes after the meal). Postprandial glycemia (time frame: 180 minutes after the meal).

It also tracked 3 secondary outcomes, for example Hypoglycemia episodes, Glucose Area Under the Curve (AUC) and Mean amplitude of glycemic excursion.

What This Means in Plain Language

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