Effect of Splitting Mealtime Insulin Doses After Mixed Meals High in Fat and Protein

What Was Tested

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

However, several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals.

There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen.

It had three arms (groups): Arm 1 (usual treatment) (active comparator), one (active comparator) and one (active comparator).

Intervention A.

Intervention B.

Intervention C.

The registry classes the interventions as drug.

More on the Plan

The study will include children and adolescents aged 6 - 18 years, diagnosed with T1DM for at least 1 year, using multiple daily injection regimen and carbohydrate counting.

The test meals will consist of two slices of a deep pan pizza base topped with tomato sauce, mozzarella full fat soft cheese, and minced beef.

The meal will be consumed within 20 minutes.

Capillary blood glucose level will be measured by a calibrated finger-prick blood glucose meter before the meals and every hour for the next 6 hours after the test meals.

Who Took Part

Enrollment: 43 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Children and adolescents aged 6 - 18 years. Diagnosed with T1DM for at least 1 year. Using MDI regimen with advanced carbohydrate counting for at least 6 months.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: subjects with associated; diabetic autonomic neuropathy; celiac disease.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Lispro 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 Lispro and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2021-04-12 with completion listed for 2021-11-25.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Capillary blood glucose levels before the test meals (time frame: before the test meals). Capillary blood glucose levels one hour after the test meals (time frame: one hour after the test meal). Capillary blood glucose levels two hours after the test meals (time frame: two hours after the test meal).

It also tracked 2 secondary outcomes, for example assessment of serum cholesterol level three hours after the test meal following each intervention and assessment of serum triglyceride level three hours after the test meal following each intervention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 43 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.