Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Aspart.

The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device.

This is to give participants insulin automatically.

The CGM device is already available for sale.

It had two arms (groups): Fast-acting insulin aspart, default tmax setting (experimental) and Fast-acting insulin aspart, non-default tmax setting (experimental).

Participants will receive fast-acting insulin aspart using the iLet™ with default tmax setting (t65 = 65 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort.

Participants will receive fast-acting insulin aspart using the iLet™ with non-default tmax setting (t50 = 50 minutes, t40 = 40 minutes or t30 = 30 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort.

The registry classes the interventions as device and drug.

Who Took Part

24 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age more than or equal to 18 years and less than or equal to 75 years at the time of signing informed consent. Diagnosed with type 1 diabetes mellitus more than or equal to 1 year prior to the day of screening. Treated with continuous subcutaneous insulin infusion more than or equal to 1 year prior to the day of screening. Familiar with continuous glucose monitoring as judged by the investigator.

The full record lists 11 inclusion and 16 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; previous participation in this trial. participation is defined as signed informed consent; participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2019-02-25 with completion listed for 2019-05-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in Low Interstitial Glucose (Defined as Below [amount hidden]/dL [[amount hidden]/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage). Time in Low Interstitial Glucose (Defined as Below [amount hidden]/dL [[amount hidden]/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median.

It also tracked 13 secondary outcomes, for example Number of Treatment Emergent Severe Hypoglycaemic Episodes, Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, Mean Interstitial-glucose Level and Number of Treatment Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 24 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 Aspart compound page, all human trials.