Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump

What Was Tested

The trial (phase 3) is built around Insulin Aspart.

The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication.

In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal).

However, many patients perform their bolus after the meal.

It had two arms (groups): Group 1 (experimental) and Group 2 (experimental).

Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF). Intervention: drug (insulin Aspart).

Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE). Intervention: drug (insulin Aspart).

The registry classes the interventions as drug.

More on the Plan

In practice every day, some patients perform their bolus immediately after eating, not just before, allowing them to know exactly the amount of ingested carbohydrates and not the one provided in advance.

This study is very interesting because it allows to compare the injection of an analogous bolus of fast insulin before and after the meal.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Major patients with type 1 diabetes treated with insulin pump.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: unbalanced diabetes,; ongoing pregnancy known,; gastrointestinal neuropathy known,.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2015-09 with completion listed for 2016-03.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under Curve (AUC) of glycemia (time frame: During 14 days).

It also tracked 2 secondary outcomes, for example Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability and Area Under Curve (AUC) during 4H after a high-fat meal.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 22 people.

Its size is small, so on its own it can only give an early look.

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, all human trials.