A Study of LY8888AX in Participants Using a Connected Insulin Management Platform

What Was Tested

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

The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform.

Approximately 50 participants will be enrolled in each country.

It had 1 arm (groups): Humalog Tempo Pen With CGM Monitoring (experimental).

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 36 actual participants took part.

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: Have been diagnosed (clinically) with T1D for at least 1 year or are patients with T2D on basal bolus insulin therapy for at least 6 months. Are currently using the Dexcom G6 CGM or agree to start using the Dexcom G6 during the study and agree to switch to Glooko RMA. Have in-home refrigeration for storage of insulin.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: previously used the glooko rma and/or dexcom g6 cgm and were judged by the investigator to be non-adherent; have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening; are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-10-05 with completion listed for 2024-09-16.

It ran at 9 sites in France (9).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 24 secondary outcomes, for example Coefficient of Variation for Glucose, Mean Glucose as Measured by CGM, Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? and Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin Lispro in 36 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.