A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes.

The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to.

This study will last approximately 12-18 days, not including screening.

It had 1 arm (groups): AID System Containing Insulin Lispro (experimental).

The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year. Have a body mass index of 18.5 to 35 kilogram per meter squared.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: have known allergies or history of hypersensitivity to insulin lispro; have had an episode of severe hypoglycemia within the past 6 months; have had more than 1 episode of diabetic ketoacidosis in the past 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 2017-11-08 with completion listed for 2018-02-09.

It ran at 1 site in United States.

Its stated primary purpose is device feasibility.

What Was Measured

Primary outcome: Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity (time frame: Up to 4 hours post challenge).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Insulin Lispro in 30 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 Lispro compound page, all human trials.