Fast-Acting Insulin Aspart and Insulin Pump Settings

What Was Tested

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

To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.

The aim of this study is twofold: 1. to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy. 2. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.

It had two arms (groups): Iasp-Fiasp (experimental) and Fiasp-Iasp (experimental).

First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp.

First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp.

The registry classes the interventions as drug.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes for ≥ 5 years. Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion). CGM use for ≥ 6 months (all CGM makes are eligible for inclusion). Carbohydrate counting for all snacks and meals. Use of the insulin pump bolus calculator for all meals and snacks.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods; gastroparesis (clinical assessment); shift work.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2021-02-01 with completion listed for 2022-06-30.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in range (time frame: Last two weeks of the 16-week interventions).

It also tracked 12 secondary outcomes, for example Mean glucose, Coefficient of variation, Time below range level 1, Time below range level 2, Time above range level 1 and Time above range level 2.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 40 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.