Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D

What Was Tested

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

It had two arms (groups): Lyumjev insulin using settings determined by experimental conversion factor (experimental) and Humalog or Novolog using optimized insulin settings (active comparator).

All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then use Lyumjev insulin for a two-week period with insulin settings determined using the conversion factor.

All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then remain on their home Humalog or Novolog for a two-week period using the optimized insulin settings. Each group will have their time-in-range during the randomized phase compared to that during the baseline period.

The registry classes the interventions as device.

More on the Plan

All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group.

After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings.

Participants will then be randomized to switch to Lyumjev insulin (with insulin settings determined using the conversion factor) or remain on their home Humalog or Novolog for a two-week period.

Each group will have their time-in-range during the randomized phase compared to that during the baseline period.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 12 years up to 22 years.

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

Examples of who could join: Age ≥12.0 and ≤22 years old at time of consent. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year. Currently using insulin for at least six months. Currently using the Tandem t:slim insulin pump with Control-IQ Technology® for at least two months. Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study.

The full record lists 16 inclusion and 9 exclusion criteria; among the exclusions: history of diabetic ketoacidosis (dka) in the 6 months prior to enrollment; severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment; current hba1c \<6.5 or \>12.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2025-07-23 with completion listed for 2026-02-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time in Range ([amount hidden]/dL).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Insulin Lispro in 11 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 and the Insulin Lispro compound page, all human trials.