Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes

What Was Tested

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

Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages.

Traditionally, insulin is injected before a meal.

It had two arms (groups): Group 1: A-F-A-F (active comparator) and Groupe 2: F-A-F-A (active comparator).

The registry classes the interventions as drug.

More on the Plan

The use of Insulin faster-acting aspart insulin will facilitate the functional insulin therapy.

Each treatment period will last 3 months.

CGM (free style libre, Abott) will be performed for 2 weeks at baseline and after each 4 months period.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 10 years with no upper age limit.

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

Examples of who could join: Patient with cystic fibrosis related diabetes aged over 10 years (no upper age limite). Patient treated by multiple insulin injections (minimal three insulin injections per day or basal bolus insulin regimen) or insulin pump. Naive patient of Fiasp or patient under Fiasp, having carried out a run-in period of one month with rapid acting insulin treatment. Affiliated to a social security scheme. Subject able to understand the objectives and the risks related to the research and to give a dated and signed informed consent.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: patient with type 1 or type 2 diabetes; patient with cystic fibrosis related diabetes treated with 2 injections / day; patient pregnant (positive urinary pregnancy test) or wishing to pregnancy.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-08-17 with completion listed for 2025-01-20.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of time in range of blood glucose variation ([amount hidden]/dl) versus baseline at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months) is assessed.

It also tracked 14 secondary outcomes, for example Other CGM parameters: mean glucose value per day (mg/dl), Markers of nutritional status: Body Mass Index (BMI), Markers of nutritional status : bioelectrical impedance - Albumin and Pre albumin, Markers of nutritional status : Albumin and Pre albumin (g/l), Markers of metabolic status: HbA1c (mmol/l and %) and Markers of metabolic status: daily exogenous need of insulin (UI/day).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 38 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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