A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system.

The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection.

It had three arms (groups): AID-count (active comparator), AID-estimate (experimental) and AID-detect (experimental).

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 12 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: Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria. Insulin pump use for at least 3 months. Willing to switch to Lyumjev insulin for the duration of the study.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: use of oral antihyperglycemic agents within 2 weeks of admission (sglt2i, metformin…); 1 month for glp1-ra; use of hydroxyurea; planned or ongoing pregnancy.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

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

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

It started in 2023-12-20 with completion listed for 2024-12.

It ran at 1 site in Canada.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Percentage of time of glucose levels spent in the target range ([amount hidden]/L).

It also tracked 11 secondary outcomes, for example Mean glucose levels, Standard deviation of glucose levels, Standard deviation of insulin delivery, Coefficient of variance of glucose levels, Coefficient of variance of insulin delivery and Total insulin delivery (overall, basal, and bolus).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 12 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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