Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart.

Study duration will be about 3 weeks per subject, 5 month overall.

It had two arms (groups): Fast-CL (experimental) and Regular-CL (active comparator).

Glucose control using DreaMed Glucositter and Fiasp® (Fast-CL).

Glucose control using DreaMed Glucositter and regular insulin Aspart.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 25 years.

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

Examples of who could join: The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment. Documented evidence should exist within the patient history of T1D. The subject is between 18 and 25 years of age (inclusive) at the time of enrolment. The subject has been treated with an insulin pump for at least 3 months. The subject is willing to follow all study instructions.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator; female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study; subject has a history of one or more episodes of diabetic ketoacidosis (dka) requiring hospitalization within a month prior to the screening.

How the Study Was Run

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

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.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-07-10 with completion listed for 2017-11-01.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time within range [amount hidden]/l ([amount hidden]/dl).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 20 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.