A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes

What Was Tested

This registered not phased trial tested Insulin Glargine and Insulin Lispro.

The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes.

The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone application.

The application will be used to record and track diabetes-data related information.

It had 1 arm (groups): IIM System (experimental).

The IIM system is comprised of an insulin lispro pen and/or an insulin glargine pen (both U-100), an investigational mobile medical application (MMA) that transmits data to cloud storage, an investigational Bluetooth Low Energy® (BLE)-paired insulin data transmission (IDT) module and a compatible commercially available BLE-paired blood glucose meter (BGM).

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 67 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: Diagnosed (clinically) with type 1 diabetes (T1D) for at least 1 year or type 2 diabetes (T2D) for at least 6 months. Using insulin injection regimen of basal/bolus or basal only for 3 months prior to screening, which includes:. For bolus insulin (U-100) - a rapid-acting insulin analog (glulisine, lispro, or aspart). For basal insulin - degludec (U-100 or U-200), detemir (U-100), or glargine (U- 100 or U-300). Participants with T1D must be on insulin only.

The full record lists 21 inclusion and 16 exclusion criteria; among the exclusions: have experienced an episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 3 months prior to screening; have hypoglycemia unawareness as judged by the investigator; history of renal transplantation, receiving renal dialysis, or diagnosed with stage iv chronic kidney disease.

How the Study Was Run

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

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

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

It started in 2020-07-14 with completion listed for 2020-12-22.

It ran at 5 sites in United States (5).

Its stated primary purpose is device feasibility.

What Was Measured

Researchers chose this as the main measure: Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients (time frame: 10 Weeks).

It also tracked 2 secondary outcomes, for example Overall Ease of Use of the IIM System and Likelihood of Site to Recommend the IIM System.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin Glargine and Insulin Lispro in 67 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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