A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes

What Was Tested

This registered phase 2, phase 3 trial tested Insulin Lispro and Amylin (Islet Amyloid Polypeptide).

The researchers also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system.

It had three arms (groups): one (experimental), one (experimental) and Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Design- All participants will undergo three interventions in a random order: (i) Fully automated Lyumjev insulin-pramlintide delivery system.

(ii) Fully automated Lyumjev insulin-pramlintide delivery system.

(iii) Hybrid automated Lyumjev insulin-placebo delivery system with carbohydrate-matched boluses.

Participants who do not currently use Lyumjev will be switched to it for the duration of the study.

Who Took Part

Enrollment: 30 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: Individuals ≥ 18 years of age. Using insulin pump therapy for at least three months.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: individuals with confirmed gastroparesis; use of medication that alters gastrointestinal motility (ex: domperidone); use of hydroxyurea.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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

It started in 2023-11-30 with completion listed for 2025-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of time of glucose levels spent in the target range ([amount hidden]/L).

It also tracked 14 secondary outcomes, for example Mean glucose levels, Standard deviation of glucose levels, Coefficient of variance of glucose levels, Total pramlintide delivery (overall, basal, and bolus), Total insulin delivery (overall, basal, and bolus) and Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin Lispro and Amylin (Islet Amyloid Polypeptide) in 30 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 and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.