Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes

What Was Tested

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

This study is a multicenter, open-label, randomized, cross-over trial in 12 subjects.

It had two arms (groups): Lyumjev (insulin lispro) (experimental) and Humalog (insulin lispro) (active comparator).

The registry classes the interventions as drug.

More on the Plan

(Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1.

Both are insulin lispro, but additions to the insulin lispro allow the insulin to act faster with a shorter duration.

Study design: This study is a multicenter, open-label, randomized, cross-over trial which will be performed in a free-living environment.

Study population: The study population will comprise 12 subjects with diabetes type 1 using the AP system.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diagnosed with diabetes mellitus type 1;. Age between 18 and 75 years;. Willing and able to sign informed consent. Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months;. BMI \< 35 kg/m\^2;.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: impaired awareness of hypoglycemia (score ≥ 4) according to gold and/or clarke questionnaire;; pregnancy and/or breastfeeding;; hypersensitivity reactions to lyumjev or any of the excipients.

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.

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 2022-10-19 with completion listed for 2023-03-16.

It ran at 3 sites in Netherlands (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Time the Glucose Level is Above [amount hidden]/l.

It also tracked 10 secondary outcomes, for example Side Effects of Insulin, AP-related Parameters: Daily Insulin Usage (Units), AP-related Parameters: Glucagon Usage and AP-related Parameters: Algorithm Activity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Lispro in 12 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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