Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?

What Was Tested

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

The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.

It had two arms (groups): Insulin Aspart (active comparator) and Insulin Fiasp (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 77 planned participants were the target.

It was open to people of any sex aged from 6 years up to 17 years.

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

Examples of who could join: ≥1 year of a history of type 1 diabetes;. Treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;. Using continuous glucose monitoring system for at least 1 month;. Consent to participate in the study obtained from the parent and the patient (\>16 years of age).

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: diabetes treated with multiple insulin injections with insulin pens (multiple daily injections, mdi);; the withdrawal of the consent to participate in the study.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

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

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

It started in 2021-03-01 with completion listed for 2023-03-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycaemia difference in time in range (TIR) [amount hidden]/dl. Glycaemia difference in time in range (TIR) [amount hidden]/dl.

It also tracked 6 secondary outcomes, for example Glycaemia difference in time below range (TBR), Glycaemia difference in time above range (TAR), Glycaemia difference in the coefficient of variation (CV), Difference in the average glycemia levels + standard deviation and Difference in the basal rate of insulin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 77 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, all human trials.