Insulin Pump to Multiple Daily Injection Transition Clinical Trial

What Was Tested

The trial (phase 4) is built around Insulin Aspart.

It had two arms (groups): Standard of Care Transition (active comparator) and Inverstigational Transition (experimental).

Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections.

The registry classes the interventions as drug.

Who Took Part

38 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: Age ≥18 years and ≤ 65 years. Patients with T1D diagnosed for at least 12 months. Patients on CSII (any insulin pump) for at least past 6 months. Willing and able to wear a blinded CGM during the time of study period. Willing to perform self-monitoring of blood glucose (SMBG) at least 4 times a day.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: age \<18 years and \> 65years; less than 12 months of insulin treatment; patients with t1d using any glucose lowering medications other than insulin.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-01-10 with completion listed for 2020-10-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time Spent With CGM Glucose Levels >[amount hidden]/dl Between Two Groups.

It also tracked 6 secondary outcomes, for example Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization, Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups and Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 38 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.